The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity

Not Applicable

Not yet recruiting

• Conditions: Sphincter of Oddi Laxity
• Interventions: Procedure: Roux-en-Y Hepaticojejunostomy; Procedure: T-tube drainage

• Registration Number: NCT04218669
• Lead Sponsor: xpgeng

Brief Summary

Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.

Detailed Description

Background: SOL results in reflux of duodenal fluid and enteric bacteria infection, which lead to the formation of stones in the biliary tract. Roux-en-Y hepaticojejunostomy (HJ) shows considerable advantage for prevention of reflux of intestinal content into the bile duct. As a result, A randomized controlled trial (RCT) evaluate the therapeutic safety, and perioperative and long-term outcomes of HJ versus T tube drainage for hepatolithiasis with SOL.

Intervention: In total, 210 patients who met the following eligibly criteria were included and were randomized to choledochojejunostomy arm or T tube drainage in a 1:1 ratio.

Clinical data include: the incidence of biliary complications (stone recurrence; biliary stricture; cholangitis); sphincter of oddi function; biliary leakage; mortality; hepatic injury; quality of life.

Study Timeline

• Study First Submitted: 2019-12-31
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-02
• Study First Posted: 2020-01-06
• Last Update Posted: 2020-01-06
• Study Start: 2020-02-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Age age between 18 and 70 years
2. Diagnosed as hepatolithiasis with sphincter of oddi laxity during operation
3. Achieved removing the focus, extraction of stones and correction of stricture during the operation
4. Written Informed consent
5. Willingness for complete 3-year follow-up.

Exclusion Criteria

1. Participation in concurrent intervention trials with interference of outcome of this study
2. Associated tumor
3. Diagnosed as sphincter of oddi complete loss of function or normal
4. Underwent choledochojejunostomy at past
5. Lack of compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roux-en-Y Hepaticojejunostomy	Roux-en-Y Hepaticojejunostomy	biliary-enteric anastomosis was performed
T-tube drainage	T-tube drainage	The T-tube was placed for biliary drainage

Primary Outcome Measures

Name	Time	Method
stone recurrence rate	3 years	A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)
biliary stricturer rate	3 years	Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)
Cholangitis rate	3 years	The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)

Secondary Outcome Measures

Name	Time	Method
sphincter of oddi function	an expected average of 120 minutes	Grading criteria for the SO function were as follows: Normal; Laxity and Loss of function
Mortality	90 days	Operative mortality was defined as any death resulting from a complication during surgery
quality of life grading	3 years	Quality of life will be assessed by Visick score (Ⅰ～Ⅳ).
Biliary leakage	90 days	Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
total bilirubin	90 days	serum total bilirubin on 3 postoperative day (umol/L)