| 1. |
- de Graaf, Nine, et al.
(författare)
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Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2) : study protocol for an international multicenter patient-blinded randomized controlled trial
- 2023
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Ingår i: Trials. - : BioMed Central Ltd. - 1745-6215. ; 24:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration: ISRCTN27483786. Registered on August 2, 2023. © 2023, BioMed Central Ltd., part of Springer Nature.
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| 2. |
- Engstrand, J., et al.
(författare)
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The Resection Rate of Synchronously Detected Liver and Lung Metastasis from Colorectal Cancer Is Low-A National Registry-Based Study
- 2023
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Ingår i: Cancers. - : MDPI AG. - 2072-6694. ; 15:5
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Tidskriftsartikel (refereegranskat)abstract
- Simple Summary Real-life data on the occurrence and treatment of synchronously detected liver and lung metastases from colorectal cancer are lacking. Through the merging of several Swedish nationwide patient quality registries, we aimed to answer these questions. We found that synchronous liver and lung colorectal metastases are rare and that a minority undergo resection of both metastatic sites, but if they do, they have an excellent survival. It is likely that a larger proportion of patients could be offered treatment that leads to a prolonged overall survival. We also found differences in regional treatment approaches across Sweden, but the reasons for this are unknown, which warrants further studies. Population-based data on the incidence and surgical treatment of patients with colorectal cancer (CRC) and synchronous liver and lung metastases are lacking as are real-life data on the frequency of metastasectomy for both sites and outcomes in this setting. This is a nationwide population-based study of all patients having liver and lung metastases diagnosed within 6 months of CRC between 2008 and 2016 in Sweden identified through the merging of data from the National Quality Registries on CRC, liver and thoracic surgery and the National Patient Registry. Among 60,734 patients diagnosed with CRC, 1923 (3.2%) had synchronous liver and lung metastases, of which 44 patients had complete metastasectomy. Surgery of liver and lung metastases yielded a 5-year OS of 74% (95% CI 57-85%) compared to 29% (95% CI 19-40%) if liver metastases were resected but not the lung metastases and 2.6% (95% CI 1.5-4%) if non-resected, p < 0.001. Complete resection rates ranged from 0.7% to 3.8% between the six healthcare regions of Sweden, p = 0.007. Synchronous liver and lung CRC metastases are rare, and a minority undergo the resection of both metastatic sites but with excellent survival. The reasons for differences in regional treatment approaches and the potential of increased resection rates should be studied further.
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| 3. |
- Johansen, Karin, 1990-
(författare)
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Effects of Pancreatic Surgery : Quality of Life, Cost-effectiveness and Postoperative Results
- 2023
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- BACKGROUND Pancreatic operations are large procedures with high rates of complications and other potentially impactful consequences such as diabetes and pancreatic exocrine insufficiency. Due to this, and due to the fact that the operations are often occasioned by periampullary tumours with a poor prognosis, it is important to evaluate how the operations affect patients in terms of postoperative results and quality of life. In the constantly developing field of pancreatic surgery, it is also important to evaluate the cost-effectiveness of new methods. METHODS The first study was a register study including all patients in the Swedish National Pancreatic and Periampullary Cancer Registry with a diagnosis from 2010-2018 who underwent pancreaticoduodenectomy (PD). Patients were divided into age groups of <70, 70-79 and ≥80 years old and were compared regarding preoperative, perioperative and postoperative data as well as survival. The second and third studies were based on the randomized controlled trial LAPOP performed in Linköping from 2015-2019 where 60 patients were randomized 1:1 to open or laparoscopic distal pancreatectomy and followed for two years with repeated quality of life questionnaires. For the second study, the EORTC QLQ-C30 and PAN26 questionnaires were collected and compared between groups. For the third study, the EQ-5D questionnaire was used in a cost-effectiveness analysis together with costs collected from patients’ medical records, including all health care-related costs up to 2 years postoperatively. Nonparametric bootstrapping with 10 000 samples was performed to compare quality-adjusted life years (QALYs) and costs between groups. The fourth study was a qualitative interview study in which 20 patients undergoing total pancreatectomy (TP) from 2020-2021 in Linköping or Karolinska University Hospitals were interviewed 6-9 months postoperatively about symptoms and life changes after the operation. RESULTS In the first study, 2793 patients underwent PD in the study period, of which 1137 patients were 70-79 years of age, and 148 patients were ≥80 years of age. There were no significant differences between groups regarding short-term mortality or the rate of severe complications according to the Clavien-Dindo classification of complications. Patients in the two older groups had a worse preoperative condition and a higher rate of medical and some surgical complications postoperatively. In the LAPOP trial, 54 patients were included in the quality of life analysis. There was a significant difference in six of the quality of life-domains measured with QLQ-C30 and PAN26 with better results in the laparoscopic group. When comparing values at the two-year measurement, 3 domains had a significant difference and 16 domains a clinically relevant difference of 10 or more, all with better results in the laparoscopic group. In the cost-effectiveness analysis, 56 patients were included in the analysis. Mean health care costs were €3 863 lower in the laparoscopic group (95% CI: -€8 020 to €385), and the QALYs were 0.08 higher (95% CI: -0.09 to 0.25). In the bootstrap analysis, 79% of samples had higher QALYs and lower costs for the laparoscopic group, and 95% were in favour of laparoscopic resection with a cost-per-QALY threshold of €50 000. Patients undergoing total pancreatectomy voiced symptoms and life changes that revolved around the two main themes: ‘changes in everyday life’ and ‘psychological journey’. In the former, patients described the impact of diabetes, food intake, diarrhoea and the process of recovery, where diabetes in particular appeared to be challenging for some. In the second theme, patients outlined the diagnosis processing, the importance of support from family, friends and the health care system, and a need for more thorough information. CONCLUSIONS Despite a worse preoperative condition, elderly patients undergoing PD did not have an increase in short-term mortality or serious complications. With continued careful preoperative examination, in particular regarding cardiovascular comorbidity, octogenarians can likely safely continue to be offered to undergo PD. After distal pancreatectomy, there was a considerable difference between groups regarding postoperative quality of life in favour of the laparoscopic method, which seemed to remain as long as 2 years postoperatively. The laparoscopic method was also favoured in the cost-effectiveness analysis where it was associated with lower costs and higher QALYs. These results support the ongoing transition from open to minimally invasive distal pancreatectomies. After TP, patients struggle with a lack of support and education, particularly regarding their diabetes treatment. Efforts should be undertaken to improve and standardize the diabetes care for this group.
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| 4. |
- Johansen, Karin, 1990-, et al.
(författare)
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Laparoscopic distal pancreatectomy is more cost-effective than open resection: results from a Swedish randomized controlled trial
- 2023
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Ingår i: HPB. - : ELSEVIER SCI LTD. - 1365-182X .- 1477-2574. ; 25:8, s. 972-979
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundLaparoscopic distal pancreatectomy is being implemented worldwide. The aim of this study was to perform a cost-effectiveness analysis from a health care perspective.MethodsThis cost-effectiveness analysis was based on the randomized controlled trial LAPOP, where 60 patients were randomized to open or laparoscopic distal pancreatectomy. For the follow-up of two years, resource use from a health care perspective was recorded, and health-related quality of life was assessed using the EQ-5D-5L. The per-patient mean cost and quality-adjusted life years (QALYs) were compared using nonparametric bootstrapping.ResultsFifty-six patients were included in the analysis. The mean health care costs were lower, €3863 (95% CI: -€8020 to €385), for the laparoscopic group. Postoperative quality of life improved with laparoscopic resection and resulted in a gain in QALYs of 0.08 (95% CI: −0.09 to 0.25). The laparoscopic group had lower costs and improved QALYs in 79% of bootstrap samples. With a cost-per-QALY threshold of €50 000, 95.4% of the bootstrap samples were in favour of laparoscopic resection.ConclusionLaparoscopic distal pancreatectomy is associated with numerically lower health care costs and improvements in QALYs compared with the open approach. The results support the ongoing transition from open to laparoscopic distal pancreatectomies.
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| 5. |
- Korrel, Maarten, et al.
(författare)
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Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial
- 2023
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Ingår i: The Lancet Regional Health. - : ELSEVIER. - 2666-7762. ; 31
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Tidskriftsartikel (refereegranskat)abstract
- Background The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, & GE;1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of -7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI -6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0-30.0] vs 23.0 [14.0-32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0-30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5-5.5] vs 5 [95% CI 4.7-5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67-1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society. Copyright & COPY; 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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| 6. |
- Trulsson, Charlotte, et al.
(författare)
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Attitudes and perceptions of healthcare professionals related to family participation in surgical cancer care - A mixed method study
- 2023
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Ingår i: Nursing Open. - : Wiley. - 2054-1058. ; 10:4, s. 2530-2539
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Tidskriftsartikel (refereegranskat)abstract
- AimThis study investigated healthcare professionals attitudes and perceptions towards the familys participation in surgical cancer care. DesignA prospective mixed method study. MethodsThe study was conducted at three hospitals in Sweden with registered nurses, assistant nurses and surgeons. Data included 43 completed Families Importance in Nursing Care (FINC-NA) questionnaires answered by registered nurses and qualitative data from 14 interviews with surgeons and assistant nurses. Data analysis was performed according to the Creswell convergent parallel mixed method. ResultsBoth quantitative and qualitative data demonstrated that the family was an important resource in nursing care, was highly valued as a conversational partner and had resources that should be considered. Each family should be supported in determining their role and as implements for maintaining a functioning family constellation and increasing their participation. Patient or Public ContributionNo patient or public contribution.
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| 7. |
- van Ramshorst, Tess M. E., et al.
(författare)
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Benchmarking of robotic and laparoscopic spleen-preserving distal pancreatectomy by using two different methods
- 2023
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Ingår i: British Journal of Surgery. - : Oxford University Press. - 0007-1323 .- 1365-2168. ; 110:1, s. 76-83
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Tidskriftsartikel (refereegranskat)abstract
- Background Benchmarking is an important tool for quality comparison and improvement. However, no benchmark values are available for minimally invasive spleen-preserving distal pancreatectomy, either laparoscopically or robotically assisted. The aim of this study was to establish benchmarks for these techniques using two different methods. Methods Data from patients undergoing laparoscopically or robotically assisted spleen-preserving distal pancreatectomy were extracted from a multicentre database (2006-2019). Benchmarks for 10 outcomes were calculated using the Achievable Benchmark of Care (ABC) and best-patient-in-best-centre methods. Results Overall, 951 laparoscopically assisted (77.3 per cent) and 279 robotically assisted (22.7 per cent) procedures were included. Using the ABC method, the benchmarks for laparoscopically assisted and robotically assisted spleen-preserving distal pancreatectomy respectively were: 150 and 207 min for duration of operation, 55 and 100 ml for blood loss, 3.5 and 1.7 per cent for conversion, 0 and 1.7 per cent for failure to preserve the spleen, 27.3 and 34.0 per cent for overall morbidity, 5.1 and 3.3 per cent for major morbidity, 3.6 and 7.1 per cent for pancreatic fistula grade B/C, 5 and 6 days for duration of hospital stay, 2.9 and 5.4 per cent for readmissions, and 0 and 0 per cent for 90-day mortality. Best-patient-in-best-centre methodology revealed milder benchmark cut-offs for laparoscopically and robotically assisted procedures, with operating times of 254 and 262.5 min, blood loss of 150 and 195 ml, conversion rates of 5.8 and 8.2 per cent, rates of failure to salvage spleen of 29.9 and 27.3 per cent, overall morbidity rates of 62.7 and 55.7 per cent, major morbidity rates of 20.4 and 14 per cent, POPF B/C rates of 23.8 and 24.2 per cent, duration of hospital stay of 8 and 8 days, readmission rates of 20 and 15.1 per cent, and 90-day mortality rates of 0 and 0 per cent respectively. Conclusion Two benchmark methods for minimally invasive distal pancreatectomy produced different values, and should be interpreted and applied differently. This study established benchmark values for laparoscopically and robotically assisted spleen-preserving distal pancreatectomy in both unselected and low-risk patients using two validated methodologies. The benchmark values require different interpretation and application based on the purpose of benchmarking and the patient cohort, and can be used for in-hospital and interhospital comparison and improvement purposes.
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