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

Cholelithiasis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02915770
• Other study ID #: 2014(18)
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2016
• Last updated: September 26, 2016
• Start date: December 2015
• Est. completion date: May 2017

Study information

• Verified date: September 2016
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiojejunostomy
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

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

Device:
• T-tube
T-tube Drainage

Locations

Country	Name	City	State
China	Hepatobiliary Surgery Institute, Southwest Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of bile duct stones		2-3 years	Yes