Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct

NCT ID: NCT02915770

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cholangiojejunostomy Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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participants receive cholangiojejunostomy

participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage

Group Type EXPERIMENTAL

cholangiojejunostomy

Intervention Type PROCEDURE

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

hepatectomy

Intervention Type PROCEDURE

T-tube

Intervention Type DEVICE

T-tube Drainage

participants receive no cholangiojejunostomy

participants will receive hepatectomy and T-tube Drainage

Group Type ACTIVE_COMPARATOR

hepatectomy

Intervention Type PROCEDURE

T-tube

Intervention Type DEVICE

T-tube Drainage

Interventions

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cholangiojejunostomy

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

Intervention Type PROCEDURE

hepatectomy

Intervention Type PROCEDURE

T-tube

T-tube Drainage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Dajiang li

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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xin 1 zhao, doctor

Role: primary

86-23-68765805 ext. 1

Other Identifiers

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2014(18)

Identifier Type: -

Identifier Source: org_study_id

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