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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatolithiasis; Sphincter of Oddi Laxity
• Intervention / Treatment: Procedure: Roux-en-Y choledochojejunostomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • the First Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Liang TingBo, MD, PHD; Phone Number: 086-571-87236688; Email: liangtingbo@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Just clear the stone without choledochojejunostomy
Experimental: Experimental Group; Clear the stone combined with Roux-en-y choledochojejunostomy	Procedure: Roux-en-Y choledochojejunostomy; Roux-en-Y choledochojejunostomy must be operated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recurrence rate of hepatolithiasis	within five years after the operation

Collaborators and Investigators

• Sponsor: TingBo Liang

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: hepatolithiasis; sphincter of oddi laxity; choledochojejunostomy
• Other Study ID Numbers: ZYYYSOL