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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatolithiasis, Sphincter of Oddi Laxity

Intervention / Treatment
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* Procedure: Roux-en-Y choledochojejunostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatolithiasis, sphincter of oddi laxity, choledochojejunostomy