Evidence map›Paper›PMID 26473652›Full record

Trial reportAnnals of surgery2016

Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula.

Manabu Kawai, Seiko Hirono, Ken-Ichi Okada, Masayuki Sho, Yoshiyuki Nakajima, Hidetoshi Eguchi, Hiroaki Nagano, Hisashi Ikoma, Ryou Morimura, Yutaka Takeda and 4 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01384617 (Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy), which is not on this map. Cited by 56 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 5 pooled it
4.7field-weighted citation impact, top 3% 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.

NCT01384617 nacompletednot on this map

Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy

TypeinterventionalSponsorWakayama Medical UniversityRan2011 to 2016Enrolled136ConditionsPancreatic Cancer, Pancreatic Cystic Lesions, Chronic Pancreatitis, Pancreatic Neuroendocrine TumorsArmsStapling closure of the pancreatic stump, Roux-en-Y anastomosis of the pancreatic stump
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 5 syntheses or guidelines pooled it, 112 citations in OpenAlex.

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  8. Reinforced staplers for distal pancreatectomy.Langenbeck's archives of surgery · 2017
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Manabu Kawai*Second Department of Surgery, Wakayama Medical University, Wakayama, Japan†Department of Surgery, Nara Medical University, Nara, Japan‡Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan§Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan||Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan¶Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Hyogo, Japan.
Seiko Hirono
Ken-Ichi Okada
Masayuki Sho
Yoshiyuki Nakajima
Hidetoshi Eguchi
Hiroaki Nagano
Hisashi Ikoma
Ryou Morimura
Yutaka Takeda
Shin Nakahira
Kazuhiro Suzumura
Jiro Fujimoto
Hiroki Yamaue
Wakayama Medical University · JPNara Medical University · JPKansai Rosai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure.

backgroundSeveral studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump.

methodsOne hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617).

resultsSixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group (P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ (P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group (P = 0.080).

conclusionsPJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.

Indexed as

PancreaticojejunostomySurgical StaplingSuture TechniquesAdultAgedBody Mass IndexFemaleHumansMaleMiddle AgedOperative TimePancreatectomyPancreatic FistulaPancreatic NeoplasmsProspective StudiesRisk Factors

Identifiers

PMID26473652
PMCPMC4902322
OpenAlexW2205632361

What OpenQuestion holds

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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.