Evidence map›Paper›PMID 34137446›Full record

SynthesisBJS open2021

Randomized clinical trial and meta-analysis of the impact of a fibrin sealant patch on pancreatic fistula after distal pancreatectomy: CPR trial.

T H Mungroop, N van der Heijde, O R Busch, I H de Hingh, J J Scheepers, M G Dijkgraaf, B Groot Koerkamp, M G Besselink, C H van Eijck

Registry-linked trialOpen access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in BJS open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06814249 (A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
1.9field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT06814249 naenrolling by invitationnot on this mapstarted 2024, after this paper: background citation

A Prospective Cohort Study on Ligation of Pancreatic Stump With Quantified Force During Distal Pancreatectomy

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2024 to 2025Enrolled60ConditionsDistal Pancreatectomy, Postoperative Pancreatic FistulaArmsligation of pancreatic stump with a quantified force, Manual suturing or stapling closure.
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  19. Pancreatic Fistula after Distal Pancreatectomy with Stapler.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

T H MungroopDepartment of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-4464-3510
N van der HeijdeDepartment of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-0961-4108
O R BuschDepartment of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
I H de HinghDepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands.
J J ScheepersDepartment of Surgery, Erasmus MC, Rotterdam, the Netherlands.
M G DijkgraafDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
B Groot KoerkampDepartment of Surgery, Erasmus MC, Rotterdam, the Netherlands.
M G BesselinkDepartment of Surgery, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-2650-9350
C H van EijckDepartment of Surgery, Erasmus MC, Rotterdam, the Netherlands.
Amsterdam University Medical Centers · NLErasmus MC · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative pancreatic fistula (POPF) remains the main cause of morbidity in patients after distal pancreatectomy. The objective of this study was to investigate whether an absorbable fibrin sealant patch could prevent POPF after distal pancreatectomy.

methodsA multicentre, patient-blinded, parallel-group randomized superiority trial was performed in seven Dutch hospitals. Allocation was done using a computer-generated randomization list with a 1 : 1 allocation ratio and concealed varying permuted block sizes. Pancreatic stump closure with a fibrin patch was compared with standard treatment in patients undergoing distal pancreatectomy. The primary endpoint was the development of grade B/C POPF. A systematic review and meta-analysis was performed which combined the present findings with all available evidence.

resultsBetween October 2010 and August 2017, 247 patients were enrolled. Fifty-four patients (22.2 per cent) developed a POPF, 25 of 125 patients in the patch group versus 29 of 122 in the control group (20.0 versus 23.8 per cent; P = 0·539). No related adverse effects were observed. In the meta-analysis, no significant difference was seen between the patch and control groups (19.7 versus 22.0 per cent; odds ratio 0.89, 95 per cent c.i. 0.60 to 1.32; P = 0·556).

conclusionApplication of a fibrin patch to the pancreatic stump does not reduce the incidence of POPF in distal pancreatectomy. Future studies should focus on alternative fistula mitigation strategies, considering pancreatic neck thickness and duct size as risk factors. Trial registration number NL5876 (Netherlands Trial Registry).

Indexed as

Fibrin Tissue AdhesivePancreatic FistulaHumansMulticenter Studies as TopicPancreasPancreatectomyRandomized Controlled Trials as TopicFibrin Tissue Adhesive

Identifiers

PMID34137446
PMCPMC8262074
OpenAlexW3172419471

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.