Evidence map›Paper›PMID 27530630›Full record

Trial reportTrials2016

One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial.

Shu-Bo Pan, Wei Geng, Da-Chen Zhou, Jiang-Ming Chen, Hong-Chuan Zhao, Fu-Bao Liu, Sheng-Xue Xie, Hui Hou, Yi-Jun Zhao, Kun Xie and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02511951 (A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02511951 phase3unknown statusnot on this map

A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy

TypeinterventionalSponsorThe Second Hospital of Anhui Medical UniversityRan2015 to 2018Enrolled114ConditionsPancreatic FistulaArmspancreaticojejunostomy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Severity of Pancreatic Leak in Relation to Gut Restoration After Pancreaticoduodenectomy: The Role of the Roux-en-Y Configuration.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2022
    Article
  5. Pancreaticojejunostomy-a review of modern techniques.Langenbeck's archives of surgery · 2020
    Review
  6. 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

12 authors.

Shu-Bo PanDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
Wei GengDepartment of Liver Surgery, Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University, No. 1630 Dongfang Road, Shanghai, 200127, China.
Da-Chen ZhouDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
Jiang-Ming ChenDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
Hong-Chuan ZhaoDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
Fu-Bao LiuDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
Sheng-Xue XieDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
Hui HouDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
Yi-Jun ZhaoDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
Kun XieDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
Guo-Bin WangDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
Xiao-Ping GengDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China. xp_geng@163.net.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough various pancreaticojejunal duct-to-mucosa anastomosis methods have been developed to reduce the postoperative risks of pancreaticoduodenectomy, pancreatic fistula remains the most serious complication with a high incident rate. The aim of this study is to compare the safety and effectiveness of one-layer and two-layer duct-to-mucosa pancreaticojejunostomy in patients undergoing pancreaticoduodenectomy. METHODS/

designIn this study, adult patients who sign consent forms will be recruited and scheduled for elective pancreaticoduodenectomy. One hundred and fourteen patients will be included and randomized before pancreaticojejunal reconstruction and after resection of the lesion from the pancreatic or periampullary region. The primary efficacy endpoint is the incident rate of postoperative pancreatic fistula. Statistical analysis will be based on the intention-to-treat population. Patients will be followed up for 3 months by monitoring for complications and other adverse events. DISCUSSION: This prospective, single-center, randomized, single-blinded, two-group parallel trial is designed to compare one-layer with two-layer duct-to-mucosa anastomosis for pancreaticojejunal anastomosis during elective pancreaticoduodenectomy.

trial registrationClinical Trials.gov: NCT02511951 . Registered on 29 July 2015.

Indexed as

PancreaticoduodenectomyAdolescentAdultAgedAged, 80 and overChinaClinical ProtocolsFemaleHumansIntestinal MucosaJejunumMaleMiddle AgedPancreatic DuctsPancreatic FistulaPancreaticojejunostomyDuct-to-mucosaPancreaticoduodenectomyPancreaticojejunostomyPostoperative pancreatic fistula

Identifiers

PMID27530630
PMCPMC4988010

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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.