| 1. |
- Labori, Knut Jørgen, et al.
(author)
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Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1) : a multicentre, randomised, phase 2 trial
- 2024
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In: The Lancet Gastroenterology & Hepatology. - : The Lancet Group. - 2468-1253. ; 9:3, s. 205-217
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Journal article (peer-reviewed)abstract
- BackgroundIn patients undergoing resection for pancreatic cancer, adjuvant modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) improves overall survival compared with alternative chemotherapy regimens. We aimed to compare the efficacy and safety of neoadjuvant FOLFIRINOX with the standard strategy of upfront surgery in patients with resectable pancreatic ductal adenocarcinoma.MethodsNORPACT-1 was a multicentre, randomised, phase 2 trial done in 12 hospitals in Denmark, Finland, Norway, and Sweden. Eligible patients were aged 18 years or older, with a WHO performance status of 0 or 1, and had a resectable tumour of the pancreatic head radiologically strongly suspected to be pancreatic adenocarcinoma. Participants were randomly assigned (3:2 before October, 2018, and 1:1 after) to the neoadjuvant FOLFIRINOX group or upfront surgery group. Patients in the neoadjuvant FOLFIRINOX group received four neoadjuvant cycles of FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and fluorouracil 400 mg/m2 bolus then 2400 mg/m2 over 46 h on day 1 of each 14-day cycle), followed by surgery and adjuvant chemotherapy. Patients in the upfront surgery group underwent surgery and then received adjuvant chemotherapy. Initially, adjuvant chemotherapy was gemcitabine plus capecitabine (gemcitabine 1000 mg/m2 over 30 min on days 1, 8, and 15 of each 28-day cycle and capecitabine 830 mg/m2 twice daily for 3 weeks with 1 week of rest in each 28-day cycle; four cycles in the neoadjuvant FOLFIRINOX group, six cycles in the upfront surgery group). A protocol amendment was subsequently made to permit use of adjuvant modified FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2 over 46 h on day 1 of each 14-day cycle; eight cycles in the neoadjuvant FOLFIRINOX group, 12 cycles in the upfront surgery group). Randomisation was performed with a computerised algorithm that stratified for each participating centre and used a concealed block size of two to six. Patients, investigators, and study team members were not masked to treatment allocation. The primary endpoint was overall survival at 18 months. Analyses were done in the intention-to-treat (ITT) and per-protocol populations. Safety was assessed in all patients who were randomly assigned and received at least one cycle of neoadjuvant or adjuvant therapy. This trial is registered with ClinicalTrials.gov, NCT02919787, and EudraCT, 2015-001635-21, and is ongoing.FindingsBetween Feb 8, 2017, and April 21, 2021, 77 patients were randomly assigned to receive neoadjuvant FOLFIRINOX and 63 to undergo upfront surgery. All patients were included in the ITT analysis. For the per-protocol analysis, 17 (22%) patients were excluded from the neoadjuvant FOLFIRINOX group (ten did not receive neoadjuvant therapy, four did not have pancreatic ductal adenocarcinoma, and three received another neoadjuvant regimen), and eight (13%) were excluded from the upfront surgery group (seven did not have pancreatic ductal adenocarcinoma and one did not undergo surgical exploration). 61 (79%) of 77 patients in the neoadjuvant FOLFIRINOX group received neoadjuvant therapy. The proportion of patients alive at 18 months by ITT was 60% (95% CI 49–71) in the neoadjuvant FOLFIRINOX group versus 73% (62–84) in the upfront surgery group (p=0·032), and median overall survival by ITT was 25·1 months (95% CI 17·2–34·9) versus 38·5 months (27·6–not reached; hazard ratio [HR] 1·52 [95% CI 1·00–2·33], log-rank p=0·050). The proportion of patients alive at 18 months in per-protocol analysis was 57% (95% CI 46–67) in the neoadjuvant FOLFIRINOX group versus 70% (55–83) in the upfront surgery group (p=0·14), and median overall survival in per-protocol population was 23·0 months (95% CI 16·2–34·9) versus 34·4 months (19·4–not reached; HR 1·46 [95% CI 0·99–2·17], log-rank p=0·058). In the safety population, 42 (58%) of 73 patients in the neoadjuvant FOLFIRINOX group and 19 (40%) of 47 patients in the upfront surgery group had at least one grade 3 or worse adverse event. 63 (82%) of 77 patients in the neoadjuvant group and 56 (89%) of 63 patients in the upfront surgery group had resection (p=0·24). One sudden death of unknown cause and one COVID-19-related death occurred after the first cycle of neoadjuvant FOLFIRINOX. Adjuvant chemotherapy was initiated in 51 (86%) of 59 patients with resected pancreatic ductal adenocarcinoma in the neoadjuvant FOLFIRINOX group and 44 (90%) of 49 patients with resected pancreatic ductal adenocarcinoma in the upfront surgery group (p=0·56). Adjuvant modified FOLFIRINOX was given to 13 (25%) patients in the neoadjuvant FOLFIRINOX group and 19 (43%) patients in the upfront surgery group. During adjuvant chemotherapy, neutropenia (11 [22%] patients in the neoadjuvant FOLFIRINOX group and five [11%] in the upfront surgery group) was the most common grade 3 or worse adverse event.InterpretationThis phase 2 trial did not show a survival benefit from neoadjuvant FOLFIRINOX in resectable pancreatic ductal adenocarcinoma compared with upfront surgery. Implementation of neoadjuvant FOLFIRINOX was challenging. Future trials on treatment sequencing in resectable pancreatic ductal adenocarcinoma should be biomarker driven.
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| 2. |
- Ansari, Daniel, et al.
(author)
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Pancreatic cancer : Yesterday, today and tomorrow
- 2016
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In: Future Oncology. - : Future Medicine Ltd. - 1479-6694 .- 1744-8301. ; 12:16, s. 1929-1946
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Journal article (peer-reviewed)abstract
- Pancreatic cancer is one of our most lethal malignancies. Despite substantial improvements in the survival rates for other major cancer forms, pancreatic cancer survival rates have remained relatively unchanged since the 1960s. Pancreatic cancer is usually detected at an advanced stage and most treatment regimens are ineffective, contributing to the poor overall prognosis. Herein, we review the current understanding of pancreatic cancer, focusing on central aspects of disease management from radiology, surgery and pathology to oncology.
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| 3. |
- Ansari, Daniel, et al.
(author)
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Pancreaticoduodenectomy - the transition from a low- to a high-volume center.
- 2014
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In: Scandinavian Journal of Gastroenterology. - : Informa UK Limited. - 1502-7708 .- 0036-5521. ; 49:4, s. 481-484
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Journal article (peer-reviewed)abstract
- Abstract Objective. Previous studies have identified a significant volume-outcome relationship for hospitals performing pancreaticoduodenectomy (PD). However, scant information exists concerning the effects of increased caseload of PD within the same hospital. Here, we describe the effects of becoming a high-volume provider of PD. Material and methods. The study group comprised 221 patients who underwent PD between 2000 and 2012. Hospital volume was allocated into three groups: low-volume (<10 PDs/year), years 2000-2004, n = 25; medium-volume (10-24 PDs/year), years 2005-2009, n = 86; and high-volume (≥25 PDs/year), years 2010-2012, n = 110. Results. The annual number of PDs increased from 5 in 2000 to 39 in 2012. The median operative duration decreased over the volume categories (p < 0.001). Intraoperative blood loss dropped (p < 0.001). The need for intraoperative blood transfusion was reduced (p < 0.001). Increasing hospital volume was associated with fewer reoperations (p = 0.041) and shorter postoperative length of stay (p = 0.010). There was a tendency toward reduced mortality: 4.0% for the low-volume period, 2.3% for the medium-volume period, and 0% for the high-volume period (p = 0.066). Conclusions. The transition from a low- to a high-volume center resulted in optimized outcomes for PD and 0% operative mortality, favoring the continued centralization of this high-risk operation.
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| 4. |
- Augustinus, Simone, et al.
(author)
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Ideal Outcome After Pancreatoduodenectomy : A Transatlantic Evaluation of a Harmonized Composite Outcome Measure
- 2023
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In: Annals of Surgery. - 0003-4932. ; 278:5, s. 740-747
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Journal article (peer-reviewed)abstract
- Objective: The aim of this study is to define and assess Ideal Outcome in the national or multicenter registries of North America, Germany, the Netherlands, and Sweden. Background: Assessing outcomes after pancreatoduodenectomy among centers and countries requires a broad evaluation that cannot be captured by a single parameter. Previously, 2 composite outcome measures (textbook outcome and optimal pancreatic surgery) for pancreatoduodenectomy have been described from Europe and the United States. These composites were harmonized into ideal outcome (IO). Methods: This analysis is a transatlantic retrospective study (2018-2020) of patients after pancreatoduodenectomy within the registries from North America, Germany, The Netherlands, and Sweden. After 3 consensus meetings, IO for pancreatoduodenectomy was defined as the absence of all 6 parameters: (1) in-hospital mortality, (2) severe complications - Clavien-Dindo ≥3, (3) postoperative pancreatic fistula - International Study Group of Pancreatic Surgery (ISGPS) grade B/C, (4) reoperation, (5) hospital stay >75th percentile, and (6) readmission. Outcomes were evaluated using relative largest difference (RLD) and absolute largest difference (ALD), and multivariate regression models. Results: Overall, 21,036 patients after pancreatoduodenectomy were included, of whom 11,194 (54%) reached IO. The rate of IO varied between 55% in North America, 53% in Germany, 52% in The Netherlands, and 54% in Sweden (RLD: 1.1, ALD: 3%, P<0.001). Individual components varied with an ALD of 2% length of stay, 4% for in-hospital mortality, 12% severe complications, 10% postoperative pancreatic fistula, 11% reoperation, and 9% readmission. Age, sex, absence of chronic obstructive pulmonary disease, body mass index, performance status, American Society of Anesthesiologists (ASA) score, biliary drainage, absence of vascular resection, and histologic diagnosis were associated with IO. In the subgroup of patients with pancreatic adenocarcinoma, country, and neoadjuvant chemotherapy also was associated with improved IO. Conclusions: The newly developed composite outcome measure "Ideal Outcome"can be used for auditing and comparing outcomes after pancreatoduodenectomy. The observed differences can be used to guide collaborative initiatives to further improve the outcomes of pancreatic surgery.
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| 5. |
- Davis, Catherine H., et al.
(author)
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Impact of Neoadjuvant Therapy for Pancreatic Cancer : Transatlantic Trend and Postoperative Outcomes Analysis
- 2024
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In: Journal of the American College of Surgeons. - 1879-1190. ; 238:4, s. 613-621
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Journal article (peer-reviewed)abstract
- BACKGROUND: The introduction of modern chemotherapy a decade ago has led to increased use of neoadjuvant therapy (NAT) in patients with pancreatic ductal adenocarcinoma (PDAC). A recent North American study demonstrated increased use of NAT and improved operative outcomes in patients with PDAC. The aims of this study were to compare the use of NAT and short-term outcomes in patients with PDAC undergoing pancreatoduodenectomy (PD) among registries from the US and Canada, Germany, the Netherlands, and Sweden. STUDY DESIGN: Databases from 2 multicenter (voluntary) and 2 nationwide (mandatory) registries were queried from 2018 to 2020. Patients undergoing PD for PDAC were compared based on the use of upfront surgery vs NAT. Adoption of NAT was measured in each country over time. Thirty-day outcomes, including the composite measure (ideal outcomes), were compared by multivariable analyses. Sensitivity analyses of patients undergoing vascular resection were performed. RESULTS: Overall, 11,402 patients underwent PD for PDAC with 33.7% of patients receiving NAT. The use of NAT increased steadily from 28.3% in 2018 to 38.5% in 2020 (p < 0.0001). However, use of NAT varied widely by country: the US (46.8%), the Netherlands (44.9%), Sweden (11.0%), and Germany (7.8%). On multivariable analysis, NAT was significantly (p < 0.01) associated with reduced rates of serious morbidity, clinically relevant pancreatic fistulae, reoperations, and increased ideal outcomes. These associations remained on sensitivity analysis of patients undergoing vascular resection. CONCLUSIONS: NAT before PD for pancreatic cancer varied widely among 4 Western audits yet increased by 26% during 3 years. NAT was associated with improved short-term outcomes.
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| 6. |
- Ekström, Eva, et al.
(author)
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Impact of body constitution on complications following pancreaticoduodenectomy : A retrospective cohort study
- 2017
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In: International Journal of Surgery. - : Ovid Technologies (Wolters Kluwer Health). - 1743-9191. ; 48, s. 116-121
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Journal article (peer-reviewed)abstract
- Background Overweight, defined by body mass index (BMI), is correlated to complications following pancreaticoduodenectomy (PD). The aim of this study was to evaluate the impact of body constitution, measured with different anthropometric measures, and diabetes on complications following PD. Materials and methods Patients who underwent PD between 2000 and 2015 at Skåne University Hospital were retrospectively included. Body mass index (BMI), body surface area (BSA) and body fat percentage (BF%) were calculated. Overweight and obesity were defined by BMI according to the WHO classification (overweight ≥25 and obesity ≥30). Values equal to or above the median value were considered as large by BSA (≥1.87) and overweight by BF% (≥29.6% (male) and ≥38.9% (female)). Main endpoints were events of postoperative pancreatic fistula (POPF), post pancreatectomy hemorrhage (PPH), delayed gastric emptying (DGE) and complications classified according to the Clavien-Dindo classification. Multivariable analysis was performed using logistic regression and a subgroup analysis on diabetic patients was performed. Results In total 328 patients were included. The incidence of POPF grades B and C was increased among overweight and large patients defined by BMI (OR 4.16; p = 0.001), BSA (OR 2.88; p = 0.018) and BF% (OR 3.94; p = 0.001). However, the risk was not increased among diabetic patients with BMI≥25 and BMI≥30. DGE and complications classified as Clavien grade ≥3 were more common in patients defined as overweight by both BMI (OR 1.72; p = 0.024 and OR 2.63; p = 0.003, respectively) and BF% (OR 2.13; p = 0.001 and OR 2.31; p = 0.009, respectively). PPH was not more frequent in overweight or large patients. Conclusion Body constitution has an impact on the risk of severe complications following PD. BMI, BSA and BF% can all be used to identify risk groups. The risk of developing POPF grades B and C was significantly increased in overweight and large patients, but not in patients with coexisting diabetes.
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| 7. |
- Gleeson, Elizabeth M., et al.
(author)
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Failure to Rescue After Pancreatoduodenectomy : A Transatlantic Analysis
- 2021
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In: Annals of Surgery. - 1528-1140. ; 274:3, s. 459-466
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Journal article (peer-reviewed)abstract
- OBJECTIVE: This analysis aimed to compare failure to rescue (FTR) after pancreatoduodenectomy across the Atlantic. SUMMARY BACKGROUND DATA: FTR, or mortality after development of a major complication, is a quality metric originally created to compare hospital results. FTR has been studied in North American and Northern European patients undergoing pancreatoduodenectomy (PD). However, a direct comparison of FTR after PD between North America and Northern Europe has not been performed. METHODS: Patients who underwent PD in North America, the Netherlands, Sweden and Germany (GAPASURG dataset) were identified from their respective registries (2014-17). Patients who developed a major complication defined as Clavien-Dindo ≥3 or developed a grade B/C postoperative pancreatic fistula (POPF) were included. Preoperative, intraoperative, and postoperative variables were compared between patients with and without FTR. Variables significant on univariable analysis were entered into a logistic regression for FTR. RESULTS: Major complications occurred in 6188 of 22,983 patients (26.9%) after PD, and 504 (8.1%) patients had FTR. North American and Northern European patients with complications differed, and rates of FTR were lower in North America (5.4% vs 12%, P < 0.001). Fourteen factors from univariable analysis contributing to differences in patients who developed FTR were included in a logistic regression. On multivariable analysis, factors independently associated with FTR were age, American Society of Anesthesiology ≥3, Northern Europe, POPF, organ failure, life-threatening complication, nonradiologic intervention, and reoperation. CONCLUSIONS: Older patients with severe systemic diseases are more difficult to rescue. Failure to rescue is more common in Northern Europe than North America. In stable patients, management of complications by interventional radiology is preferred over reoperation.
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| 8. |
- Hau, Sofie Olsson, et al.
(author)
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Chemotherapy, host response and molecular dynamics in periampullary cancer : The CHAMP study
- 2020
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In: BMC Cancer. - : Springer Science and Business Media LLC. - 1471-2407. ; 20:1
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Journal article (peer-reviewed)abstract
- Background: Pancreatic cancer is a devastating disease with a dismal prognosis. Despite profound medical advances in systemic therapies for other types of aggressive tumours during recent years, a diagnosis of pancreatic cancer is still often synonymous with a fatal outcome. The term periampullary cancer includes pancreatic cancer and applies to the group of tumours found in proximity to the ampulla of Vater. Molecular events and immune response in the host during chemotherapy remain largely unexplored in this group of tumours. Therefore, the "Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer (CHAMP)" study aims to monitor these processes to gain new insight into this perplexing disease. Methods: The CHAMP study is a prospective, single-arm observational study. All patients diagnosed with pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, are invited to participate. Clinical and pathological data will be compiled at study entry. A single tissue microarray (TMA) block is constructed for each patient with a resected tumour and blood samples are drawn before, during and after chemotherapy in order to sample peripheral blood mononuclear cells (PBMC), cytokines and circulating tumour DNA (ctDNA). Next generation sequencing will be performed on tumour tissue and ctDNA to detect changes in the clonal landscape over space and time. Discussion: Despite the recent emergence of some promising biomarkers for periampullary cancer, there has been a lack of success in clinical implementation. Cancer cells continuously adapt and become resistant to treatment during chemotherapy. To be able to keep pace with and hopefully overtake this rapid evolution we must, with the help of new diagnostic tools, be ready to adapt and alter treatment accordingly. It seems to us that the only way forward is to gain a better understanding of the dynamics of the disease during treatment. With insights gained from the CHAMP study we hope to find answers to key questions in this largely unexplored territory. Trial registration: This study has been registered 30th October 2018 at clinicaltrials.gov as NCT03724994.
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| 9. |
- Kuemmerli, Christoph, et al.
(author)
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Are enhanced recovery protocols after pancreatoduodenectomy still efficient when applied in elderly patients? A systematic review and individual patient data meta-analysis
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In: Journal of Hepato-Biliary-Pancreatic Sciences. - 1868-6974.
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Research review (peer-reviewed)abstract
- Background: This meta-analysis investigated the effects of enhanced recovery after surgery (ERAS) protocols compared to conventional care on postoperative outcomes in patients aged 70 years or older undergoing pancreatoduodenectomy (PD). Methods: Five databases were systematically searched. Comparative studies with available individual patient data (IPD) were included. The main outcomes were postoperative morbidity, length of stay, readmission and postoperative functional recovery elements. To assess an age-dependent effect, the group was divided in septuagenarians (70–79 years) and older patients (≥80 years). Results: IPD were obtained from 15 of 31 eligible studies comprising 1109 patients. The overall complication and major complication rates were comparable in both groups (OR 0.92 [95% CI: 0.65–1.29], p =.596 and OR 1.22 [95% CI: 0.61–2.46], p =.508). Length of hospital stay tended to be shorter in the ERAS group compared to the conventional care group (−0.14 days [95% CI: −0.29 to 0.01], p =.071) while readmission rates were comparable and the total length of stay including days in hospital after readmission tended to be shorter in the ERAS group (−0.28 days [95% CI: −0.62 to 0.05], p =.069). In the subgroups, the length of stay was shorter in octogenarians treated with ERAS (−0.36 days [95% CI: −0.71 to −0.004], p =.048). The readmission rate increased slightly but not significantly while the total length of stay was not longer in the ERAS group. Conclusion: ERAS in the elderly is safe and its benefits are preserved in the care of even in patients older than 80 years. Standardized care protocol should be encouraged in all pancreatic centers.
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| 10. |
- Kuemmerli, Christoph, et al.
(author)
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Impact of enhanced recovery protocols after pancreatoduodenectomy : meta-analysis
- 2022
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In: The British journal of surgery. - : Oxford University Press (OUP). - 1365-2168 .- 0007-1323. ; 109:3, s. 256-266
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Journal article (peer-reviewed)abstract
- BACKGROUND: This individual-patient data meta-analysis investigated the effects of enhanced recovery after surgery (ERAS) protocols compared with conventional care on postoperative outcomes in patients undergoing pancreatoduodenectomy. METHODS: The Cochrane Library, MEDLINE, Embase, Scopus, and Web of Science were searched systematically for articles reporting outcomes of ERAS after pancreatoduodenectomy published up to August 2020. Comparative studies were included. Main outcomes were postoperative functional recovery elements, postoperative morbidity, duration of hospital stay, and readmission. RESULTS: Individual-patient data were obtained from 17 of 31 eligible studies comprising 3108 patients. Time to liquid (mean difference (MD) -3.23 (95 per cent c.i. -4.62 to -1.85) days; P < 0.001) and solid (-3.84 (-5.09 to -2.60) days; P < 0.001) intake, time to passage of first stool (MD -1.38 (-1.82 to -0.94) days; P < 0.001) and time to removal of the nasogastric tube (3.03 (-4.87 to -1.18) days; P = 0.001) were reduced with ERAS. ERAS was associated with lower overall morbidity (risk difference (RD) -0.04, 95 per cent c.i. -0.08 to -0.01; P = 0.015), less delayed gastric emptying (RD -0.11, -0.22 to -0.01; P = 0.039) and a shorter duration of hospital stay (MD -2.33 (-2.98 to -1.69) days; P < 0.001) without a higher readmission rate. CONCLUSION: ERAS improved postoperative outcome after pancreatoduodenectomy. Implementation should be encouraged.
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| 11. |
- Latenstein, Anouk E.J., et al.
(author)
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The use and clinical outcome of total pancreatectomy in the United States, Germany, the Netherlands, and Sweden
- 2021
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In: Surgery (United States). - : Elsevier BV. - 0039-6060. ; 170:2, s. 563-570
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Journal article (peer-reviewed)abstract
- Background: Total pancreatectomy has high morbidity and mortality and differences among countries are currently unknown. This study compared the use and postoperative outcomes of total pancreatectomy among 4 Western countries. Methods: Patients who underwent one-stage total pancreatectomy were included from registries in the United States, Germany, the Netherlands, and Sweden (2014–2018). Use of total pancreatectomy was assessed by calculating the ratio total pancreatectomy to pancreatoduodenectomy. Primary outcomes were major morbidity (Clavien Dindo ≥3) and in-hospital mortality. Predictors for the primary outcomes were assessed in multivariable logistic regression analyses. Sensitivity analysis assessed the impact of volume (low-volume <40 or high-volume ≥40 pancreatoduodenectomies annually; data available for the Netherlands and Germany). Results: In total, 1,579 patients underwent one-stage total pancreatectomy. The relative use of total pancreatectomy to pancreatoduodenectomy varied up to fivefold (United States 0.03, Germany 0.15, the Netherlands 0.03, and Sweden 0.15; P <.001). Both the indication and several baseline characteristics differed significantly among countries. Major morbidity occurred in 423 patients (26.8%) and differed (22.3%, 34.9%, 38.3%, and 15.9%, respectively; P <.001). In-hospital mortality occurred in 85 patients (5.4%) and also differed (1.8%, 10.2%, 10.8%, 1.9%, respectively; P <.001). Country, age ≥75, and vascular resection were predictors for in-hospital mortality. In-hospital mortality was lower in high-volume centers in the Netherlands (4.9% vs 23.1%; P =.002), but not in Germany (9.8% vs 10.6%; P =.733). Conclusion: Considerable differences in the use of total pancreatectomy, patient characteristics, and postoperative outcome were noted among 4 Western countries with better outcomes in the United States and Sweden. These large, yet unexplained, differences require further research to ultimately improve patient outcome.
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| 12. |
- Mackay, Tara M., et al.
(author)
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Transatlantic registries of pancreatic surgery in the United States of America, Germany, the Netherlands, and Sweden : Comparing design, variables, patients, treatment strategies, and outcomes
- 2020
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In: Surgery (United States). - : Elsevier BV. - 0039-6060.
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Journal article (peer-reviewed)abstract
- Background: Registries of pancreatic surgery have become increasingly popular as they facilitate both quality improvement and clinical research. We aimed to compare registries for design, variables collected, patient characteristics, treatment strategies, clinical outcomes, and pathology. Methods: Registered variables and outcomes of pancreatoduodenectomy (2014–2017) in 4 nationwide or multicenter pancreatic surgery registries from the United States of America (American College of Surgeons National Surgical Quality Improvement Program), Germany (Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie - Studien-, Dokumentations- und Qualitätszentrum), the Netherlands (Dutch Pancreatic Cancer Audit), and Sweden (Swedish National Pancreatic and Periampullary Cancer Registry) were compared. A core registry set of 55 parameters was identified and evaluated using relative and absolute largest differences between extremes (smallest versus largest). Results: Overall, 22,983 pancreatoduodenectomies were included (15,224, 3,558, 2,795, and 1,406 in the United States of America, Germany, the Netherlands, and Sweden). Design of the registries varied because 20 out of 55 (36.4%) core parameters were not available in 1 or more registries. Preoperative chemotherapy in patients with pancreatic ductal adenocarcinoma was administered in 27.6%, 4.9%, 7.0%, and 3.4% (relative largest difference 8.1, absolute largest difference 24.2%, P < .001). Minimally invasive surgery was performed in 7.8%, 4.5%, 13.5%, and unknown (relative largest difference 3.0, absolute largest difference 9.0%, P < .001). Median length of stay was 8.0, 16.0, 12.0, and 11.0 days (relative largest difference 2.0, absolute largest difference 8.0, P < .001). Reoperation was performed in 5.7%, 17.1%, 8.7%, and 11.2% (relative largest difference 3.0, absolute largest difference 11.4%, P < .001). In-hospital mortality was 1.3%, 4.7%, 3.6%, and 2.7% (relative largest difference 3.6, absolute largest difference 3.4%, P < .001). Conclusion: Considerable differences exist in the design, variables, patients, treatment strategies, and outcomes in 4 Western registries of pancreatic surgery. The absolute largest differences of 24.3% for the use of preoperative chemotherapy, 9.0% for minimally invasive surgery, 11.4% for reoperation rate, and 3.4% for in-hospital mortality require further study and improvement. This analysis provides 55 core parameters for pancreatic surgery registries.
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| 13. |
- Olsson Hau, Sofie, et al.
(author)
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Sex and gender differences in treatment intention, quality of life and performance status in the first 100 patients with periampullary cancer enrolled in the CHAMP study
- 2023
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In: BMC Cancer. - 1471-2407. ; 23:1
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Journal article (peer-reviewed)abstract
- BACKGROUND: Periampullary cancer is a term for cancers arising in or in close proximity to the pancreas. Pancreatic cancer is the 3rd leading cause of cancer death for both sexes and while surgery is the only option for cure, chemotherapy is given in both the adjuvant and palliative settings. The aim of this study was to investigate any sex and gender differences in patients with pancreatic and other periampullary adenocarcinomas enrolled in a prospective, observational trial.METHODS: The study cohort consists of the first 100 patients, 49 women and 51 men, enrolled in the Chemotherapy, Host Response and Molecular dynamics in Periampullary cancer (CHAMP) study, an ongoing study of patients undergoing neoadjuvant, adjuvant or first-line palliative chemotherapy treatment. Twenty-five patients had surgery with curative intent and subsequent adjuvant treatment, and 75 patients were treated with palliative chemotherapy. Data regarding health-related quality of life (HRQoL, EORTC-QLQ-C30) at baseline, demographic and clinicopathological factors were examined and stratification by treatment intention according to sex. Overall survival (OS) was calculated through Kaplan-Meier analysis.RESULTS: There was a statistically significant difference between male and female patients treated with curative intent, with fewer women having undergone surgery (18 vs 7, p = 0.017), also after adjustment for age, tumor location and performance status. No statistical differences were found between the sexes regarding age, comorbidities, or clinicopathological factors. Before start of chemotherapy treatment, health-related quality of life (HRQoL) was lower in female than in male patients. However, HRQoL was not associated with performance status in female patients, whereas in male patients several HRQoL indicators were significantly positively associated with poorer performance status at baseline.CONCLUSIONS: This study shows no clear differences between the sexes regarding biological factors concluding that gender bias might be responsible for the discrepancy between men and women being offered curative surgery. The observed difference between women and men regarding the association between HRQoL and performance status is unprecedented. Altogether these findings underline the importance of taking gender into consideration when assessing eligibility for curative surgery in order to improve biological outcome and decrease suffering in both sexes.TRIAL REGISTRATION: NCT03724994.
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| 14. |
- Williamsson, Caroline, et al.
(author)
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A wait-and-see strategy with subsequent self-expanding metal stent on demand is superior to prophylactic bypass surgery for unresectable periampullary cancer.
- 2016
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In: HPB : the official journal of the International Hepato Pancreato Biliary Association. - : Elsevier BV. - 1477-2574 .- 1365-182X. ; 18:1, s. 107-12
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Journal article (peer-reviewed)abstract
- A patient with unresectable periampullary malignancy found at laparotomy has traditionallyreceived a prophylactic double bypass (biliary and duodenal), associated with considerable morbidity. With modern endoscopic treatments, surgical bypass has become questionable. This study aims to compare the two strategies. Sahlgrenska University Hospital (SU) performs a double bypass (DoB) routinely, and Skåne University Hospital Lund (SUL) secures biliary drainage endoscopically and treats only symptomatic duodenal obstruction (Wait and See, WaS).
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| 15. |
- Williamsson, Caroline, et al.
(author)
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An analysis of gender differences in treatment and outcome of periampullary tumours in Sweden – A national cohort study
- 2021
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In: HPB. - : Elsevier BV. - 1365-182X. ; 23:6, s. 847-853
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Journal article (peer-reviewed)abstract
- Background: Little is known of possible gender differences in treatment of periampullary tumours and outcome after pancreatoduodenectomy (PD), and the aim of this study was therefore to investigate any variances from national multicentre perspective. Methods: Data from the Swedish National Registry for Pancreatic and Periampullary Cancer for all patients diagnosed with a periampullary tumour from 2012 throughout 2017 was collected. The material was analysed in two groups, men and women, for palliative treatment and curative intended resection. Results: A total of 5677 patients were included, 2906 (51%) men and 2771 (49%) women. Women were older than men, 72 (65–78) years vs. 70 (64–76), p < 0.001. A lesser proportion of women were planned for resection (1131 (41%) vs. 1288 (44%), p = 0.008), but after adjusting for age and tumour location no difference was seen. Postoperative morbidity was equal, but women had significantly better long-term survival than men. The survival was equal for palliative men and women. Conclusion: No gender bias could be established when analysing treatment for periampullary tumours in Sweden, even though less women were offered surgery. Data suggest that even though women were older they tolerate surgery well and hence offering PD at a higher age for women could be suggested.
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| 16. |
- Williamsson, Caroline, et al.
(author)
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Impact of a fast-track surgery programme for pancreaticoduodenectomy.
- 2015
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In: British Journal of Surgery. - : Oxford University Press (OUP). - 1365-2168 .- 0007-1323. ; 102:9, s. 1133-1141
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Journal article (peer-reviewed)abstract
- Fast-track (FT) programmes are multimodal, evidence-based approaches to optimize patient outcome after surgery. The aim of this study was to evaluate the safety, clinical outcome and patients' experience of a FT programme after pancreaticoduodenectomy (PD) in a high-volume institution in Sweden.
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| 17. |
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| 18. |
- Williamsson, Caroline, et al.
(author)
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Postoperative pancreatic fistula-impact on outcome, hospital cost and effects of centralization
- 2017
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In: HPB. - : Elsevier BV. - 1365-182X. ; 19:5, s. 436-442
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Journal article (peer-reviewed)abstract
- Background: One of the most serious complications after pancreaticoduodenectomy (PD) is postoperative pancreatic fistula (POPF). This study investigated the incidence of POPF before and after centralization of pancreatic surgery in Southern Sweden and its impact on outcome and health care costs. Methods: The local registry comprising all pancreatic resections at Skåne University Hospital, Lund, Sweden, was searched for PDs from 2005 to 2015. The patients were analysed in three groups: low-volume, high-volume and after introduction of an enhanced recovery program. Only the clinically relevant POPF grades B and C (CR-POPF) were investigated. Results: 322 consecutive patients were identified. The annual operation volume increased almost threefold and the postoperative length of stay and total hospital cost decreased concurrently. The incidence of CR-POPF did not decrease over time. The group with CR-POPF had more complications and prolonged length of stay. The cost was 1.5 times higher for patients with CR-POPF and the cost did not decline despite the increase of hospital volume. Conclusion: Centralization of pancreatic surgery did not decrease the rate of CR-POPF nor its subsequent impact on LOS and costs. Further efforts must be made to reduce the incidence of CR-POPF.
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| 19. |
- Zdanowski, A. H., et al.
(author)
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Predictive Factors for Delayed Gastric Emptying After Pancreatoduodenectomy: A Swedish National Registry-Based Study
- 2023
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In: WORLD JOURNAL OF SURGERY. - 0364-2313. ; 47, s. 3289-3297
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Journal article (peer-reviewed)abstract
- Background Delayed gastric emptying (DGE) is a common complication after pancreatoduodenectomy (PD). DGE causes prolonged hospital stay and a decrease in quality of life. This study analyzes predictive factors for development of DGE after PD, also in the absence of surgical complications.Method Data from the Swedish National Pancreatic Cancer Registry for patients undergoing standard and pylorus preserving open PD from January 2010 until June 30, 2018, were collected. Data were analyzed in two groups, no DGE and DGE. A subgroup of patients with DGE but without surgical complications was compared to patients without DGE or any other surgical complication.Results In total, 2503 patients were included, of which 470 (19%) had DGE. In the DGE group, 238 had other coexisting surgical complications and 232 had not. Postoperative pancreatic fistula (OR = 4.22, p < 0.001), surgical infection (OR = 1.44, p = 0.013), heart disease (OR = 1.32, p = 0.023) and medical complications (OR = 1.35, p = 0.025) increased the risk for DGE. A standard PD compared with pylorus preserving resection (OR = 1.69, p = 0.001) and a reconstruction with a pancreaticojejunostomy compared with a pancreaticogastrostomy (OR = 1.83, p < 0.001) increased the risk. For patients without surgical complications, a standard PD and reconstruction with pancreaticojejunostomy still increased the risk for DGE.Conclusion DGE is more common after standard PD compared to pylorus preserving PD and after reconstruction with PJ compared to PG in this national cohort, both in the presence of other surgical complications as well as in the absence of other complications.
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