NCT02915770

Brief Summary

This study evaluates the clinical application of cholangiojejunostomy in the surgical treatment of cholelithiasis with Moderate dilatation of common bile duct. Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage, while the other half will receive hepatectomy and T-tube Drainage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

July 6, 2016

Last Update Submit

September 26, 2016

Conditions

CholangiojejunostomyCholelithiasis

Keywords

Moderate dilatation of common bile duct

Outcome Measures

Primary Outcomes (1)

  • Recurrence of bile duct stones

    2-3 years

Study Arms (2)

participants receive cholangiojejunostomy

EXPERIMENTAL

participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage

Procedure: cholangiojejunostomyProcedure: hepatectomyDevice: T-tube

participants receive no cholangiojejunostomy

ACTIVE COMPARATOR

participants will receive hepatectomy and T-tube Drainage

Procedure: hepatectomyDevice: T-tube

Interventions

cholangiojejunostomyPROCEDURE

Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage,while the other half will receive hepatectomy and T-tube Drainage

participants receive cholangiojejunostomy
hepatectomyPROCEDURE
participants receive cholangiojejunostomyparticipants receive no cholangiojejunostomy
T-tubeDEVICE

T-tube Drainage

participants receive cholangiojejunostomyparticipants receive no cholangiojejunostomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatic bile duct stone disease, need surgery
  • No residual stones in the operation
  • Extrahepatic bile duct dilatation, 15-30 mm in diam.
  • No relaxation or stenosis of the sphincter of Oddi

You may not qualify if:

  • Patient involuntary
  • Surgical treatment can not be performed because of various reasons.
  • Intrahepatic and extrahepatic bile duct stones can not be taken away
  • with other biliary tract diseases, such as bile duct cancer
  • Oddi sphincter relaxation or stenosis
  • loss to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Cholelithiasis

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 6, 2016

First Posted

September 27, 2016

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

CN(1)