Evidence map›Paper›PMID 31567180›Full record

Trial reportAnnals of surgery2019

Permanent Pancreatic Duct Occlusion With Neoprene-based Glue Injection After Pancreatoduodenectomy at High Risk of Pancreatic Fistula: A Prospective Clinical Study.

Vincenzo Mazzaferro, Matteo Virdis, Carlo Sposito, Christian Cotsoglou, Michele Droz Dit Busset, Marco Bongini, Maria Flores, Natalie Prinzi, Jorgelina Coppa

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Annals of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03738787 (Efficacy and Safety of Exocrine Pancreatectomy With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 14% 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.

NCT03738787 phase2completednot on this map

Efficacy and Safety of Exocrine Pancreatectomy With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy (PD) in Patients With Pancreatic, Papilla, Duodenal, and Distal Choledochus Neoplasm

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2015 to 2019Enrolled40ConditionsPancreatic Fistula, Pancreatic Neoplasms, Postoperative ComplicationsArmsPancreatic duct occlusion with Neoprene, Pancreato-Jejunal anastomosis
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  13. The using of sealants in pancreatic surgery: A Systematic Review.Annals of medicine and surgery (2012) · 2021
    Review
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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 2 institutions in 1 country.

Vincenzo MazzaferroDepartment of Oncology, University of Milan, Milan, Italy.
Matteo VirdisHepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Carlo SpositoDepartment of Oncology, University of Milan, Milan, Italy.
Christian CotsoglouHepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Michele Droz Dit BussetHepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Marco BonginiHepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Maria FloresHepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Natalie PrinziClinical Oncology and Endocrinology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Jorgelina CoppaHepato-Pancreatic-Biliary Surgery and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to assess safety and efficacy of pancreatic duct occlusion (PDO) with neoprene-based glue in selected patients undergoing pancreatoduodenectomy (PD) at high risk of postoperative pancreatic fistula (POPF). BACKGROUND DATA: PD is the reference standard approach for tumors of the pancreaticoduodenal region. POPF is the most relevant complication after PD. PDO has been proposed as an alternative to anastomosis to manage the pancreatic stump.

methodsA single-center, prospective, nonrandomized trial enrolled 100 consecutive PD for cancer. Patients at high risk for POPF according to Fistula Risk Score (FRS) >15% (≥6 points) were treated with PDO using neoprene glue (study cohort); patients with FRS ≤15% (≤5 points) received pancreaticojejunal anastomosis (PJA: control cohort). Primary endpoint was complication rate grade ≥3 according to Dindo-Clavien Classification (DCC). Other postoperative outcomes were monitored (ClinicalTrials.gov NCT03738787).

resultsFifty-one patients underwent PDO and 49 PJA. DCC ≥3, postoperative mortality, and POPF grade B-C were 25.5% versus 24.5% (P = 0.91), 5.9% versus 2% (P = 0.62), and 11.8% versus 16.3% (P = 0.51) in the study versus control cohort, respectively. At 1 and 3 years, new-onset diabetes was diagnosed in 13.7% and 36.7% of the study cohort versu 4.2% and 12.2% in controls (P = 0.007).

conclusionsPDO with neoprene-based glue is a safe technique that equalizes early outcome of selected patients at high risk of POPF to those at low risk undergoing PJA. Neoprene-based PDO, however, triples the risk of diabetes at 1 and 3 years.

Indexed as

AdultAgedDisease-Free SurvivalFemaleFollow-Up StudiesHumansInjections, IntralesionalKaplan-Meier EstimateMaleMiddle AgedNeoprenePancreatic DuctsPancreatic FistulaPancreatic NeoplasmsPancreaticoduodenectomyProspective StudiesNeopreneTissue Adhesives

Identifiers

PMID31567180
PMCPMC6867669
OpenAlexW2975381739

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.