Randomized Controlled Trial of Treating Hepatolithiasis (Accompanied With SOL) With Choledochojejunostomy

Hepatolithiasis Clinical Trial

Official title:

Randomized Controlled Trial of Treating Hepatolithiasis(Accompanied With Sphincter of Oddi Laxity) With Roux-en-Y Choledochojejunostomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01459549
• Other study ID #: ZYYYSOL
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2011
• Last updated: January 25, 2017
• Start date: October 2011
• Est. completion date: November 2020

Study information

• Verified date: January 2017
• Source: Zhejiang University
• Contact: Liang TingBo, MD,PHD
• Phone: 086-571-87236688
• Email: liangtingbo[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Roux-en-Y choledochojejunostomy is a more effective treatment for the hepatolithiasis patients accompanied with Sphincter of Oddi Loose.

Description:

Hepatolithiasis (HL) is prevalent in East Asia, especially in China. While this condition results from multiple etiological factors, obstructive cholangitis is usually the main cause. In our clinical experience, the investigators have found few cases with obstruction of the common bile duct or sphincter of Oddi; to the contrary, almost half of our clinical cases showed sphincter of Oddi laxity (SOL). SOL results in reflux of duodenal fluid and Escherichia coli (E. coli) infection, which lead to the formation of stones in the biliary tract. Thus, HL tends to recur in SOL patients. For these patients, Roux-en-Y choledochojejunostomy(choledochojejunostomy with an anti-reflux ansa intestinalis) may be the most promising therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2020
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed as hepatolithiasis

• sphincter of oddi laxity is diagnosed during operation

• sign the informed consent form voluntary

• can cooperate well with the followup

• anticipated to be tolerant of Roux-en-Y choledochojejunostomy

Exclusion Criteria:

• already underwent choledochojejunostomy at past, which make the function of Sphincter of Oddi unable to be evaluated

• a lot of stones remain in biliary tract after operation, which make the recurrence or progression of hepatolithiasis unable to be evaluated

Related Conditions & MeSH terms

• Hepatolithiasis
• Sphincter of Oddi Laxity

Intervention

Procedure:
• Roux-en-Y choledochojejunostomy
Roux-en-Y choledochojejunostomy must be operated

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
TingBo Liang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate of hepatolithiasis		within five years after the operation