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

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Status: Not yet enrolling

Conditions: Sphincter of Oddi Laxity

Treatments: Procedure: T-tube drainage; Procedure: Roux-en-Y Hepaticojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04218669

1804h08020239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

T-tube drainage

Active Comparator group

Description:

The T-tube was placed for biliary drainage

Treatment:

Procedure: T-tube drainage

Roux-en-Y Hepaticojejunostomy

Experimental group

Description:

biliary-enteric anastomosis was performed

Treatment:

Procedure: Roux-en-Y Hepaticojejunostomy