Trial reportBJS open2023
Polyethylene glycol-coated haemostatic patch for prevention of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy: randomized clinical trial.
Trial report in BJS open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03419676 (Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.
- Preventing pancreatic fistula following pancreatectomy: meta-analysis of randomized clinical trials.BJS open · 2026Pooled it
- Pooled it
- Reporting Standards and Quality Assurance Methods for Pancreatoduodenectomy in Randomised Controlled Trials: A Structured Narrative Review.Journal of clinical medicine · 2026Review
- Multiaction Antimicrobial, Anti-inflammatory, and Prohealing Hydrogel as a Novel Strategy for Preventing Postoperative Pancreatic Fistula.Biomaterials research · 2025Article
- Development of Composite Sponge Scaffolds Based on Carrageenan (CRG) and Cerium Oxide Nanoparticles (CeOBiomimetics (Basel, Switzerland) · 2023Article
- Pancreatic Fistulas: Current Evidence and Strategy-A Narrative Review.Journal of clinical medicine · 2023Review
- Endoscopic Transmural Therapy of Pancreatic Fistulas in an Interdisciplinary Setting-A Retrospective Data Analysis.Journal of clinical medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 NUMBER: NCT03419676 (http://www.clinicaltrials.gov).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.