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

Primary Purpose

Cholangiojejunostomy, Cholelithiasis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cholangiojejunostomy
hepatectomy
T-tube
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiojejunostomy focused on measuring Moderate dilatation of common bile duct

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

participants receive cholangiojejunostomy

participants receive no cholangiojejunostomy

Arm Description

participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage

participants will receive hepatectomy and T-tube Drainage

Outcomes

Primary Outcome Measures

Recurrence of bile duct stones

Secondary Outcome Measures

Full Information

First Posted
July 6, 2016
Last Updated
September 26, 2016
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02915770
Brief Title
Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiojejunostomy, Cholelithiasis
Keywords
Moderate dilatation of common bile duct

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
participants receive cholangiojejunostomy
Arm Type
Experimental
Arm Description
participants will receive hepatectomy、cholangiojejunostomy and T-tube Drainage
Arm Title
participants receive no cholangiojejunostomy
Arm Type
Active Comparator
Arm Description
participants will receive hepatectomy and T-tube Drainage
Intervention Type
Procedure
Intervention Name(s)
cholangiojejunostomy
Intervention Description
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
Intervention Name(s)
hepatectomy
Intervention Type
Device
Intervention Name(s)
T-tube
Intervention Description
T-tube Drainage
Primary Outcome Measure Information:
Title
Recurrence of bile duct stones
Time Frame
2-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xin 1 zhao, doctor
Phone
86-23-68765805
Ext
1
Email
zhaoxinxnyy@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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