Evidence map›Paper›PMID 29103084›Full record

Trial reportLangenbeck's archives of surgery2017

Reinforced staplers for distal pancreatectomy.

Manabu Kawai, Seiko Hirono, Ken-Ichi Okada, Sohei Satoi, Hiroaki Yanagimoto, Masanori Kon, Yoshiaki Murakami, Naru Kondo, Masayuki Sho, Takahiro Akahori and 9 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Langenbeck's archives of surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02270554 (A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 13% 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.

NCT02270554 phase2completednot on this map

A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy

TypeinterventionalSponsorWakayama Medical UniversityRan2014 to 2016Enrolled120ConditionsPancreatic NeoplasmsArmsEndo GIA Reinforced Reload with Tri-Staple technology
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. 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

19 authors at 11 institutions in 1 country.

Manabu KawaiSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.
Seiko HironoSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.
Ken-Ichi OkadaSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.
Sohei SatoiDepartment of Surgery, Kansai Medical University, Hirakata, Japan.
Hiroaki YanagimotoDepartment of Surgery, Kansai Medical University, Hirakata, Japan.
Masanori KonDepartment of Surgery, Kansai Medical University, Hirakata, Japan.
Yoshiaki MurakamiDepartment of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Naru KondoDepartment of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Masayuki ShoDepartment of Surgery, Nara Medical University, Kashihara, Japan.
Takahiro AkahoriDepartment of Surgery, Nara Medical University, Kashihara, Japan.
Hirochika ToyamaDivision of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Takumi FukumotoDivision of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Tsutomu FujiiDepartment of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.
Ippei MatsumotoDivision of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kindai University, Higashi-osaka, Japan.
Hidetoshi EguchiDepartment of Surgery, Osaka University Graduate School of Medicine, Suita, Japan.
Hisashi IkomaDivision of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Yutaka TakedaDepartment of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Jiro FujimotoDepartment of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
Hiroki YamaueSecond Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan. yamaue-h@wakayama-med.ac.jp.
Wakayama Medical University · JPKansai Medical University · JPHiroshima University · JPKobe University · JPNara Medical University · JPHyogo Medical University · JPKansai Rosai Hospital · JPKindai University · JPKyoto Prefectural University of Medicine · JPNagoya University · JPOsaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe safety and efficacy of reinforced staplers during distal pancreatectomy (DP) remain controversial because of the small sample size. This multicenter single-arm prospective study aims to evaluate the safety and efficacy of reinforced staplers with bioabsorbable material during DP.

methodsBetween October 2014 and August 2015, 121 patients scheduled for DP were enrolled in this study at 11 institutions in Japan. The primary endpoint was the incidence of clinically relevant pancreatic fistula. Protocol treatment was defined as "distal pancreatectomy using reinforced staplers."

resultsPer-protocol analysis of 105 patients was performed; 16 of the patients were excluded based on discontinuation of protocol treatment criteria. Clinically relevant pancreatic fistula occurred in 13 (12.4%) of 105 patients. The overall morbidity rate was 29.5% (31 of 105 patients) and severe complication (Clavien classification IIIa or more) was 10.5% (11/105). Mortality rate was 0%, although reoperations were performed on two patients (1.9%). Multivariate logistic regression analysis of independent risk factors for clinically relevant pancreatic fistula after DP using reinforced stapler closure was operative time more than 240 min (P = 0.047, odds ratio 5.79), registration numbers less than 10 (P = 0.046, odds ratio 13.01), and staple line hemorrhage (P = 0.003, odds ratio 16.34).

conclusionThis study confirms the safety of reinforced staplers for pancreatic stump closure during DP. However, the efficacy of reinforced staplers for decreasing clinically relevant pancreatic fistula could not be drawn from this study.

trial registrationThis prospective study was registered with ClinicalTrials.gov (NCT02270554) and UMIN Clinical Trial Registry (UMIN000015384).

Indexed as

AdultAgedAged, 80 and overFemaleHumansIncidenceMaleMiddle AgedOperative TimePancreatectomyPancreatic FistulaPancreatic NeoplasmsPostoperative ComplicationsProspective StudiesRisk FactorsSurgical StaplersDistal pancreatectomyMesh reinforcementPancreatic fistulaStapler closure

Identifiers

PMID29103084
OpenAlexW2766175575

What OpenQuestion holds

Textmetadata
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.