Effect of the Use of Reinforced Stapling on the Occurrence of Pancreatic Fistula After Distal Pancreatectomy: Results of the REPLAY (REinforcement of the Pancreas in distaL pAncreatectomY) Multicenter Randomized Clinical Trial.
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 11 2022
01 11 2022
Historique:
pubmed:
26
7
2022
medline:
12
10
2022
entrez:
25
7
2022
Statut:
ppublish
Résumé
The aim of the study was to evaluate the impact of the use of a reinforced stapler (RS) during distal pancreatectomy (DP) on postoperative outcomes. DP remains associated with significant postoperative morbidity owing to pancreatic fistula (PF). To date, there is no consensus on the management of the pancreatic stump. The use of an RS potentially represents a simple way to decrease the rate of PF. The REPLAY study (NCT03030170) is a prospective, multicenter, randomized study. Patients who underwent DP were randomized (1:1 ratio) in 2 groups for the use of a standard stapler (SS) or an RS to close remnant pancreatic parenchyma. The primary endpoint was the rate of overall PF. Secondary endpoints included severity of PF, length of hospital stay, overall morbidity, and rate of readmission for a PF within 90 days. Participants were blinded to the procedure actually carried out. A total of 199 were analyzed (SS, n=99; RS, n=100). One patient who did not undergo surgery was excluded. Baseline characteristics were comparable in both groups. The rate of overall PF was higher in RS group (SS: 67.7%, RS: 83%, P =0.0121), but the rate of clinically relevant PF was similar (SS: 11.1%, RS: 14%, P =0.5387). Mean length of total hospital stay, readmission for PF, postoperative morbidity, and mortality at 90 days were similar. The results of this randomized clinical trial did not favor the use of RS during DP to reduce the rate of PF.
Sections du résumé
OBJECTIVE
The aim of the study was to evaluate the impact of the use of a reinforced stapler (RS) during distal pancreatectomy (DP) on postoperative outcomes.
BACKGROUND
DP remains associated with significant postoperative morbidity owing to pancreatic fistula (PF). To date, there is no consensus on the management of the pancreatic stump. The use of an RS potentially represents a simple way to decrease the rate of PF.
METHODS
The REPLAY study (NCT03030170) is a prospective, multicenter, randomized study. Patients who underwent DP were randomized (1:1 ratio) in 2 groups for the use of a standard stapler (SS) or an RS to close remnant pancreatic parenchyma. The primary endpoint was the rate of overall PF. Secondary endpoints included severity of PF, length of hospital stay, overall morbidity, and rate of readmission for a PF within 90 days. Participants were blinded to the procedure actually carried out.
RESULTS
A total of 199 were analyzed (SS, n=99; RS, n=100). One patient who did not undergo surgery was excluded. Baseline characteristics were comparable in both groups. The rate of overall PF was higher in RS group (SS: 67.7%, RS: 83%, P =0.0121), but the rate of clinically relevant PF was similar (SS: 11.1%, RS: 14%, P =0.5387). Mean length of total hospital stay, readmission for PF, postoperative morbidity, and mortality at 90 days were similar.
CONCLUSION
The results of this randomized clinical trial did not favor the use of RS during DP to reduce the rate of PF.
Identifiants
pubmed: 35876371
doi: 10.1097/SLA.0000000000005618
pii: 00000658-202211000-00005
doi:
Banques de données
ClinicalTrials.gov
['NCT03030170']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
769-775Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest.
Références
Montorsi M, Zerbi A, Bassi C, et al. Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial. Ann Surg. 2012;256:853–860.
Paye F, Micelli Lupinacci R, Bachellier P, et al. Distal pancreatectomy for pancreatic carcinoma in the era of multimodal treatment. Br J Surg. 2015;102:229–236.
Kneuertz PJ, Patel SH, Chu CK, et al. Laparoscopic distal pancreatectomy: trends and lessons learned through an 11-year experience. J Am Coll Surg. 2012;215:167–176.
Mendoza AS, Han H-S, Ahn S, et al. Predictive factors associated with postoperative pancreatic fistula after laparoscopic distal pancreatectomy: a 10-year single-institution experience. Surg Endosc. 2016;30:649–656.
Chang YR, Kang JS, Jang J-Y, et al. Prediction of pancreatic fistula after distal pancreatectomy based on cross-sectional images. World J Surg. 2017;41:1610–1617.
Ecker B, McMillan M, Allegrini V, et al. Risk factors and mitigation strategies for pancreatic fistula after distal pancreatectomy: analysis of 2026 resections from the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019;269:143–149.
Miao Y, Lu Z, Yeo CJ, et al. Management of the pancreatic transection plane after left (distal) pancreatectomy: expert consensus guidelines by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2020;168:72–84.
Diener MK, Seiler CM, Rossion I, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011;377:1514–1522.
Probst P, Hüttner FJ, Klaiber U, et al. Stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy. Cochrane Database Syst Rev. 2015;11:CD008688.
Sa Cunha A, Carrere N, Meunier B, et al. Stump closure reinforcement with absorbable fibrin collagen sealant sponge (TachoSil) does not prevent pancreatic fistula after distal pancreatectomy: the FIABLE multicenter controlled randomized study. Am J Surg. 2015;210:739–748.
Park JS, Lee D, Jang J-Y, et al. Use of TachoSil patches to prevent pancreatic leaks after distal pancreatectomy: a prospective, multicenter, randomized controlled study. J Hepatobiliary Pancreat Sci. 2016;23:110–117.
Hüttner FJ, Mihaljevic AL, Hackert T, et al. Effectiveness of Tachosil in the prevention of postoperative pancreatic fistula after distal pancreatectomy: a systematic review and meta-analysis. Langenbecks Arch Surg. 2016;401:151–159.
Deng Y, He S, Cheng Y, et al. Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery. Cochrane Database Syst Rev. 2020;2020:CD009621.
Hamilton NA, Porembka MR, Johnston FM, et al. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy: a single-blinded, randomized controlled trial. Ann Surg. 2012;255:1037–1042.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: an International Study Group (ISGPF) definition. Surgery. 2005;138:8–13.
Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–591.
Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142:761–768.
Wente MN, Veit JA, Bassi C, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–25.
Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–213.
Kondo N, Uemura K, Nakagawa N, et al. A multicenter, randomized, controlled trial comparing reinforced staplers with bare staplers during distal pancreatectomy (HiSCO-07 Trial). Ann Surg Oncol. 2019;26:1519–1527.
Wennerblom J, Ateeb Z, Jönsson C, et al. Reinforced versus standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial. Br J Surg. 2021;108:265–270.
Kang MK, Kim H, Byun Y, et al. Optimal stapler cartridge selection to reduce post-operative pancreatic fistula according to the pancreatic characteristics in stapler closure distal pancreatectomy. HPB. 2021;23:633–640.
Pulvirenti A, Landoni L, Borin A, et al. Reinforced stapler versus ultrasonic dissector for pancreatic transection and stump closure for distal pancreatectomy: a propensity matched analysis. Surgery. 2019;166:271–276.
Landoni L, De Pastena M, Fontana M, et al. A randomized controlled trial of stapled versus ultrasonic transection in distal pancreatectomy. Surg Endosc. 2022;36:4033–4041.
Jang J-Y, Shin YC, Han Y, et al. Effect of polyglycolic acid mesh for prevention of pancreatic fistula following distal pancreatectomy: a randomized clinical trial. JAMA Surg. 2017;152:150–155.
Ratnayake CBB, Wells C, Hammond J, et al. Network meta-analysis comparing techniques and outcomes of stump closure after distal pancreatectomy. Br J Surg. 2019;106:1580–1589.
de Rooij T, van Hilst J, van Santvoort H, et al. Minimally invasive versus open distal pancreatectomy (LEOPARD): a multicenter patient-blinded randomized controlled trial. Ann Surg. 2019;269:2–9.
Sulpice L, Farges O, Goutte N, et al. Laparoscopic distal pancreatectomy for pancreatic ductal adenocarcinoma: time for a randomized controlled trial? Results of an all-inclusive national observational study. Ann Surg. 2015;262:868–874.