Evidence map›Paper›PMID 32600474›Full record

ArticleTrials2020

T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial.

Jiang-Ming Chen, Xi-Yang Yan, Tao Zhu, Zi-Xiang Chen, Yi-Jun Zhao, Kun Xie, Fu-Bao Liu, Xiao-Ping Geng

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04218669 (A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 89% 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.

NCT04218669 naunknown statusnot on this map

A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity

TypeinterventionalSponsorxpgengRan2020 to 2025Enrolled105ConditionsSphincter of Oddi LaxityArmsRoux-en-Y Hepaticojejunostomy, T-tube drainage
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

8 authors at 1 institution in 1 country.

Jiang-Ming ChenDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.
Xi-Yang YanDepartment of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, 230022, Anhui, China.
Tao ZhuDepartment of Anesthesiology, The First Affiliated Hospital of USTC, Tianehu Road 1#, Administrative District, Hefei, 230022, Anhui, China.
Zi-Xiang ChenDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.
Yi-Jun ZhaoDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.
Kun XieDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.
Fu-Bao LiuDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China. liufubao88@163.com.ORCID http://orcid.org/0000-0002-6247-0759
Xiao-Ping GengDepartment of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.
Anhui Medical University · CN

Funding

Anhui science and technology tackling key project NO1804h08020239.
6 · The paper itself

Abstract

backgroundResidual and recurrent stones remain one of the most important challenges of hepatolithiasis and are reported in 20 to 50% of patients treated for this condition. To date, the two most common surgical procedures performed for hepatolithiasis are choledochojejunostomy and T-tube drainage for biliary drainage. The goal of the present study was to evaluate the therapeutic safety and perioperative and long-term outcomes of choledochojejunostomy versus T-tube drainage for hepatolithiasis patients with sphincter of Oddi laxity (SOL). METHODS/

designIn total, 210 patients who met the following eligibility criteria were included and were randomized to the choledochojejunostomy arm or T-tube drainage arm in a 1:1 ratio: (1) diagnosed with hepatolithiasis with SOL during surgery; (2) underwent foci removal, stone extraction and stricture correction during the operation; (3) provided written informed consent; (4) was willing to complete a 3-year follow-up; and (5) aged between 18 and 70 years. The primary efficacy endpoint of the trial will be the incidence of biliary complications (stone recurrence, biliary stricture, cholangitis) during the 3 years after surgery. The secondary outcomes will be the surgical, perioperative and long-term follow-up outcomes. DISCUSSION: This is a prospective, single-centre and randomized controlled two-group parallel trial designed to demonstrate which drainage method (Roux-en-Y hepaticojejunostomy or T-tube drainage) can better reduce biliary complications (stone recurrence, biliary stricture, cholangitis) in hepatolithiasis patients with SOL.

trial registrationClinical Trials.gov: NCT04218669 . Registered on 6 January 2020.

Indexed as

CholedochostomyDrainageHumansLithiasisLiver DiseasesPostoperative ComplicationsProspective StudiesRandomized Controlled Trials as TopicRecurrenceSphincter of OddiTime FactorsTreatment OutcomeCholedochojejunostomyHepatolithiasisSphincter of OddiT-tube drainage

Identifiers

PMID32600474
PMCPMC7322885
OpenAlexW3037569521

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.