| 1. |
- Bureau, Christophe, et al.
(författare)
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Alfapump® system vs. large volume paracentesis for refractory ascites : a multicenter randomized controlled study
- 2017
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Ingår i: Journal of Hepatology. - : Elsevier. - 0168-8278 .- 1600-0641. ; 67:5, s. 940-949
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Tidskriftsartikel (refereegranskat)abstract
- Background and aims: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with a poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump® [AP]) compared with LVP standard of care [SoC].Methods: A randomized controlled trial, in seven centers, with six month patient observation was conducted. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival. Nutrition, hemodynamics, and renal injury biomarkers were assessed in a sub-study at three months.Results: Sixty patients were randomized and 58 were analyzed (27 AP, 31 SoC, mean age 61.9years, mean MELD 11.7). Eighteen patients were included in the sub-study. Compared with SoC, median time to first LVP was not reached after six months in the AP group, meaning a significant reduction in LVP requirement for the AP patients (AP, median not reached; SoC, 15.0days (HR 0.13; 95%CI 13.0-22.0; p<0.001), and AP patients also showed significantly improved Chronic Liver Disease Questionnaire (CLDQ) scores compared with SoC patients (p<0.05 between treatment arms). Improvements in nutritional parameters were observed for hand-grip strength (p=0.044) and body mass index (p<0.001) in the sub-study. Compared with SoC, more AP patients reported adverse events (AEs; 96.3% vs. 77.4%, p=0.057) and serious AEs (85.2 vs. 45.2%, p=0.002). AEs consisted predominantly of acute kidney injury in the immediate post-operative period, and re-intervention for pump related issues, and were treatable in most cases. Survival was similar in AP and SoC.Conclusions: The AP system is effective for reducing the need for paracentesis and improving quality of life in cirrhotic patients with RA. Although the frequency of SAEs (and by inference hospitalizations) was significantly higher in the AP group, they were generally limited and did not impact survival.Lay summary: The alfapump® moves abdominal fluid into the bladder from where it is then removed by urination. Compared with standard treatment, the alfapump reduces the need for large volume paracentesis (manual fluid removal by needle) in patients with medically untreatable ascites. This can improve life quality for these patients.
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| 2. |
- Enne, Marcelo, et al.
(författare)
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ALPPS as a salvage procedure after insufficient future liver remnant hypertrophy following portal vein occlusion
- 2017
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Ingår i: HPB. - : ELSEVIER SCI LTD. - 1365-182X .- 1477-2574. ; 19:12, s. 1126-1129
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Tidskriftsartikel (refereegranskat)abstract
- Background: A minimum future liver remnant (FLR) of 30% is required to avoid post hepatectomy liver failure (PHLF). Portal vein occlusion (PVO) is the main strategy to induce hypertrophy of the FLR, but some patients will not reach sufficient FLR hypertrophy to enable resection. Recently ALPPS has emerged as a "Salvage Procedure" for PVO failure. The aim of this study was to report the short term outcomes of ALPPS following PVO failure. Methods: A retrospective analysis of patients enrolled within the international ALPPS Registry between October 2012 and November 2015 (NCT01924741) was performed. Patients with documented PVO failure were included. The outcomes reported included feasibility, FLR growth rate and safety of ALPPS. Complications were recorded as per Clavien-Dindo classification. Results: From 510 patients enrolled in the Registry there were 22 patients with previous PVO failure. Two patients were excluded due to missing data and twenty patients were analysed. All of them completed the proposed ALPPS with a medium FLR increase of 88% (23-115%) between two stages and no 90-day mortality. Conclusion: In experienced centers, ALPPS following PVO failure is feasible and safe. The FLR hypertrophy was similar to other ALPPS series. ALPPS is a potential rescue strategy after PVO failure.
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| 3. |
- Hasselgren, Kristina, et al.
(författare)
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Neoadjuvant chemotherapy does not affect future liver remnant growth and outcomes of associating liver partition and portal vein ligation for staged hepatectomy
- 2017
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Ingår i: Surgery. - : MOSBY-ELSEVIER. - 0039-6060 .- 1532-7361. ; 161:5, s. 1255-1265
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Tidskriftsartikel (refereegranskat)abstract
- Background. The only potentially curative treatment for patients with colorectal liver metastases is hepatectomy. Associating liver partition and portal vein ligation for staged hepatectomy has emerged as a method of treatment for patients with inadequate future liver remnant. One concern about associating liver partition and portal vein ligation for staged hepatectomy is that preoperative chemotherapy may negatively affect the volume increase of the future liver remnant and outcomes. Methods. This study from the International Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy Registry (NCT01924741) includes 442 patients with colorectal liver metastases registered from 2012-2016. Future liver remnant hypertrophy (absolute increase, percent increase, and kinetic growth rate) and clinical outcome were analyzed retrospectively in relation to type and amount of chemotherapy. The analyzed groups included patients with no chemotherapy, 1 regimen of chemotherapy, amp;gt; 1 regimen, and a group that received monoclonal antibodies in addition to chemotherapy. Results. Ninety percent of the patients received neoadjuvant oncologic therapy including 42% with 1 regimen of chemotherapy, 44% with monoclonal antibodies, and 4% with amp;gt; 1 regimen. Future liver remnant increased between 74-92% with the largest increase in the group with 1 regimen of chemotherapy. The increase in milliliters was between 241 mL (amp;gt; 1 regimen) and 306 mL (1 regimen). Kinetic growth rate was between 14-18% per week and was greatest for the group with 1 regimen of chemotherapy. No statistical significance was found between the groups with any of the measurements of future liver remnant hypertrophy. Conclusion. Neoadjuvant chemotherapy, including monoclonal antibodies, does not negatively affect future liver remnant growth. Patients with colorectal liver metastases who might be potential candidates for associating liver partition and portal vein ligation for staged hepatectomy should be considered for neoadjuvant chemotherapy. (Surgery 2017;161:1255-65.)
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| 4. |
- Lang, Hauke, et al.
(författare)
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10th Anniversary of ALPPS-Lessons Learned and quo Vadis
- 2019
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Ingår i: Annals of Surgery. - : LIPPINCOTT WILLIAMS & WILKINS. - 0003-4932 .- 1528-1140. ; 269:1, s. 114-119
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) has been tested in various indications and clinical scenarios, leading to steady improvements in safety. This report presents the current status of ALPPS. Summary Background Data: ALPPS offers improved resectability, but drawbacks are regularly pointed out regarding safety and oncologic benefits. Methods: During the 12th biennial congress of the European African-Hepato-Pancreato-Biliary Association (Mainz, Germany, May 23-26, 2017) an expert meeting "10th anniversary of ALPP" was held to discuss indications, management, mechanisms of regeneration, as well as pitfalls of this novel technique. The aim of the meeting was to make an inventory of what has been achieved and what remains unclear in ALPPS. Results: Precise knowledge of liver anatomy and its variations is paramount for success in ALPPS. Technical modifications, mainly less invasive approaches like partial, mini- or laparoscopic ALPPS, mostly aiming at minimizing the extensiveness of the first-stage procedure, are associated with improved safety. In fibrotic/cirrhotic livers the degree of future liver remnant hypertrophy after ALPPS appears some less than that in noncirrhotic. Recent data from the only prospective randomized controlled trial confirmed significant higher resection rates in ALPPS with similar peri-operative morbidity and mortality rates compared with conventional 2-stage hepatectomy including portal vein embolization. ALPPS is effective reliably even after failure of portal vein embolization. Conclusions: Although ALPPS is now an established 2-stage hepatectomy additional data are warranted to further refine indication and technical aspects. Long-term oncological outcome results are needed to establish the place of ALPPS in patients with initially nonresectable liver tumors.
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| 5. |
- Linecker, Michael, et al.
(författare)
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Risk Adjustment in ALPPS Is Associated With a Dramatic Decrease in Early Mortality and Morbidity
- 2017
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Ingår i: Annals of Surgery. - : LIPPINCOTT WILLIAMS & WILKINS. - 0003-4932 .- 1528-1140. ; 266:5, s. 779-786
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To longitudinally assess whether risk adjustment in Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) occurred over time and is associated with postoperative outcome. Background: ALPPS is a novel 2-stage hepatectomy enabling resection of extensive hepatic tumors. ALPPS has been criticized for its high mortality, which is reported beyond accepted standards in liver surgery. Therefore, adjustments in patient selection and technique have been performed but have not yet been studied over time in relation to outcome. Methods: ALPPS centers of the International ALPPS Registry having performed amp;gt;= 10 cases over a period of amp;gt;= 3 years were assessed for 90-day mortality and major interstage complications (amp;gt;= 3b) of the longitudinal study period from 2009 to 2015. The predicted prestage 1 and 2 mortality risks were calculated for each patient. In addition, questionnaires were sent to all centers exploring center-specific risk adjustment strategies. Results: Among 437 patients from 16 centers, a shift in indications toward colorectal liver metastases from 53% to 77% and a reverse trend in biliary tumors from 24% to 9% were observed. Over time, 90-day mortality decreased from initially 17% to 4% in 2015 (P = 0.002). Similarly, major interstage complications decreased from 10% to 3% (P = 0.011). The reduction of 90-day mortality was independently associated with a risk adjustment in patient selection (P amp;lt; 0.001; OR: 1.62; 95% CI: 1.36-1.93) and using less invasive techniques in stage-1 surgery (P = 0.019; OR: 0.39; 95% CI: 0.18-0.86). A survey indicated risk adjustment of patient selection in all centers and ALPPS technique in the majority (80%) of centers. Conclusions: Risk adjustment of patient selection and technique in ALPPS resulted in a continuous drop of early mortality and major postoperative morbidity, which has meanwhile reached standard outcome measures accepted for major liver surgery.
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| 6. |
- Mantini, Cesare, et al.
(författare)
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Influence of image reconstruction parameters on cardiovascular risk reclassification by Computed Tomography Coronary Artery Calcium Score
- 2018
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Ingår i: European Journal of Radiology. - : Elsevier BV. - 0720-048X. ; 101, s. 1-7
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To investigate the influence of different CT reconstruction parameters on coronary artery calcium scoring (CACS) values and reclassification of predicted cardiovascular (CV) risk. Methods: CACS was evaluated in 113 patients undergoing ECG-gated 64-slice CT. Reference CACS protocol included standard kernel filter (B35f) with slice thickness/increment of 3/1.5 mm, and field-of-view (FOV) of 150–180 mm. Influence of different image reconstruction algorithms (reconstructed slice thickness/increment 2.0/1.0–1.5/0.8–3.0/2.0–3.0/3.0 mm; slice kernel B30f-B45f; FOV 200–250 mm) on Agatston score was assessed by Bland-Altman plots and concordance correlation coefficient (CCC) analysis. Classification of CV risk was based on the Mayo Clinic classification. Results: Different CACS reconstruction parameters showed overall good accuracy and precision when compared with reference protocol. Protocols with larger FOV, thinner slices and sharper kernels were associated with significant CV risk reclassification. Use of kernel B45f showed a moderate positive correlation with reference CACS protocol (Agatston CCC = 0.67), and yielded significantly higher CACS values (p <.05). Reconstruction parameters using B30f or B45f kernels, 250 mm FOV, or slice thickness/increment of 2.0/1.0 mm or 1.5/0.8 mm, were associated with significant reclassification of CV risk (p <.05). Conclusions: Kernel, FOV, slice thickness and increment are major determinants of accuracy and precision of CACS measurement. Despite high agreement and overall good correlation of different reconstruction protocols, thinner slices thickness and increment, and sharper kernels were associated with significant upward reclassification of CV risk. Larger FOV determined both upward and downward reclassification of CV risk.
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