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The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3?mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea.

ABSTRACT: BACKGROUND:Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (POPF) is an important complication because of several consequent complications, including intraabdominal haemorrhage, often increasing hospital stays and surgical mortality. Although many kinds of pancreaticojejunostomy aimed at reducing POPF have been examined to date, the technique has not yet been standardized. We devised a new method using double-coated polyglycolic acid felt after pancreaticojejunostomy. The aim of the PLANET-PJ trial is to evaluate the superiority of polyglycolic acid felt reinforcement in preventing POPF after pancreaticojejunostomy in patients undergoing partial pancreatoduodenectomy to previous anastomosis methods. METHODS:Patients diagnosed with pancreatic or periampullary lesions in whom it is judged that the main pancreatic duct diameter was 3?mm or less on the left side of the portal vein without pancreatic parenchymal atrophy due to obstructive pancreatitis are considered eligible for inclusion. This study is designed as a multicentre randomized phase III trial in Japan and the Republic of Korea. Eligible patients will be centrally randomized to either group A (polyglycolic acid felt reinforcement) or group B (control). In total, 514 patients will be randomized in 31 high-volume centres in Japan and Republic of Korea. The primary endpoint is the incidence of POPF (International Study Group of Pancreatic Surgery grade B/C). DISCUSSION:The PLANET-PJ trial evaluates the efficacy of a new method using double-coated polyglycolic acid felt reinforcement for preventing POPF after pancreaticojejunostomy. This new method may reduce POPF. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03331718 . University Hospital Medical Information Network Clinical Trials Registry, UMIN000029647. Registered on 30 November 2017. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033874.

SUBMITTER: Shibuya K

PROVIDER: S-EPMC6688253 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea.

Shibuya Kazuto K Jang Jin-Young JY Satoi Sohei S Sho Masayuki M Yamada Suguru S Kawai Manabu M Kim Hongbeom H Kim Song Cheol SC Heo Jin Seok JS Yoon Yoo-Seok YS Park Joon Seong JS Hwang Ho Kyoung HK Yoshioka Isaku I Shimokawa Toshio T Yamaue Hiroki H Fujii Tsutomu T

Trials 20190809 1

<h4>Background</h4>Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (POPF) is an important complication because of several consequent complications, including intraabdominal haemorrhage, often increasing hospital stays and surgical mortality. Although many kinds of pancreaticojejunostomy aimed at reducing POPF have been examined to date, th ...[more]

PMID: 31399139

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Project description:ImportancePostoperative pancreatic fistula is a potentially life-threatening complication after pancreatoduodenectomy. Evidence for best management is lacking.ObjectiveTo evaluate the clinical outcome of patients undergoing catheter drainage compared with relaparotomy as primary treatment for pancreatic fistula after pancreatoduodenectomy.Design, setting, and participantsA multicenter, retrospective, propensity-matched cohort study was conducted in 9 centers of the Dutch Pancreatic Cancer Group from January 1, 2005, to September 30, 2013. From a cohort of 2196 consecutive patients who underwent pancreatoduodenectomy, 309 patients with severe pancreatic fistula were included. Propensity score matching (based on sex, age, comorbidity, disease severity, and previous reinterventions) was used to minimize selection bias. Data analysis was performed from January to July 2016.ExposuresFirst intervention for pancreatic fistula: catheter drainage or relaparotomy.Main outcomes and measuresPrimary end point was in-hospital mortality; secondary end points included new-onset organ failure.ResultsOf the 309 patients included in the analysis, 209 (67.6%) were men, and mean (SD) age was 64.6 (10.1) years. Overall in-hospital mortality was 17.8% (55 patients): 227 patients (73.5%) underwent primary catheter drainage and 82 patients (26.5%) underwent primary relaparotomy. Primary catheter drainage was successful (ie, survival without relaparotomy) in 175 patients (77.1%). With propensity score matching, 64 patients undergoing primary relaparotomy were matched to 64 patients undergoing primary catheter drainage. Mortality was lower after catheter drainage (14.1% vs 35.9%; P = .007; risk ratio, 0.39; 95% CI, 0.20-0.76). The rate of new-onset single-organ failure (4.7% vs 20.3%; P = .007; risk ratio, 0.15; 95% CI, 0.03-0.60) and new-onset multiple-organ failure (15.6% vs 39.1%; P = .008; risk ratio, 0.40; 95% CI, 0.20-0.77) were also lower after primary catheter drainage.Conclusions and relevanceIn this propensity-matched cohort, catheter drainage as first intervention for severe pancreatic fistula after pancreatoduodenectomy was associated with a better clinical outcome, including lower mortality, compared with primary relaparotomy.

Project description:BackgroundThe potential of haemostatic patches to reduce the rate of postoperative pancreatic fistula remains unclear. The aim of this trial was to evaluate the impact of a polyethylene glycol-coated haemostatic patch on the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy.MethodsIn this randomized, single-centre, clinical trial, patients undergoing pancreatoduodenectomy were randomized 1 : 1 to receive pancreatojejunostomy reinforced with two polyethylene glycol-coated haemostatic patches (patch group) or without any reinforcement (control group). The primary outcome was clinically relevant postoperative pancreatic fistula, defined as grade B/C according to International Study Group of Pancreatic Surgery criteria, within 90 days. Key secondary outcomes were length of hospital stay, total rate of postoperative pancreatic fistula, and overall complication rate.ResultsFrom 15 May 2018 to 22 June 2020, 72 patients were randomized, and 64 were included in the analyses (31 in the patch group and 33 in the control group). The risk of clinically relevant postoperative pancreatic fistula was reduced by 90 per cent (OR 0.10, 95 per cent c.i. 0.01 to 0.89, P = 0.039). Moreover, the use of the polyethylene glycol-coated patch retained its protective effect on clinically relevant postoperative pancreatic fistula in a multivariable regression model, significantly reducing the risk of clinically relevant postoperative pancreatic fistula by 93 per cent (OR 0.07, 95 per cent c.i. 0.01 to 0.67, P = 0.021), regardless of patient age, sex, or fistula risk score. The incidence of secondary outcomes did not significantly differ between the groups. One patient died within 90 days in the patch group versus three patients in the control group.ConclusionsA polyethylene glycol-coated haemostatic patch reduced the incidence of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy.Registration numberNCT03419676 (http://www.clinicaltrials.gov).

Project description:Postoperative pancreatic fistula (POPF) is the most common and intractable complication after partial pancreatectomy, with an incidence of 13% to 64%. Polyglycolic acid (PGA) mesh is a new technique that is designed to prevent POPF, and its effect has been evaluated in several randomized controlled trials and some retrospective cohort studies. In this study, we systematically and comprehensively analyzed the efficacy of PGA mesh based on reported studies.We searched Medline, Embase, and Cochrane Library databases in English between January 2010 and October 2019. Analysis was performed by using Review Manger 5.3 software.Three RCTs and 8 nonrandomized studies were eligible with a total of 1598 patients including 884 PGA group patients and 714 control group patients. For pancreatoduodenectomy (PD), distal pancreatectomy (DP), and the 2 partial pancreatectomy (PD or DP), we found significant statistical differences in overall POPF (relative risk [RR] = 0.75, 95% confidence interval [CI] = 0.61-0.91, P = .004; RR = 0.74, 95% CI = 0.57-0.96, P = .02; RR = 0.76, 95% CI = 0.64-0.89, P = .0009, respectively) and clinical pancreatic fistula (PF) (RR = 0.5, 95% CI = 0.37-0.68, P < .00001; RR = 0.31, 95% CI = 0.21-0.46, P < .00001; RR = 0.41, 95% CI = 0.32-0.52, P < .00001, respectively) in favor of PGA. For partial pancreatectomy, significant statistical differences were found in overall complications (RR = 0.77, 95% CI: 0.67-0.88, P = .0002) and estimated blood loss (weighted mean difference [WMD] = -53.58; 95% CI: -101.20 to -5.97, P = .03) in favor of PGA. We did not find significant differences regarding operative time (WMD = -8.86; 95% CI: -27.59 to 9.87, P = .35) and hospital stay (WMD = -2.73; 95% CI: -7.53 to 2.06, P = .26).This meta-analysis shows the benefits of the PGA mesh technique regarding POPF, clinical PF, and postoperative complications. This still needs to be verified by more randomized control trials.

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