Clinical trial NCT04218669: The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity
Official title: A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sphincter of Oddi Laxity
Keywords: sphincter of Oddi laxity
hepatolithiasis
choledochojejunostomy
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized to choledochojejunostomy arm or T tube drainage arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: stone recurrence rate
timeFrame: 3 years
measure: biliary stricturer rate
timeFrame: 3 years
measure: Cholangitis rate
timeFrame: 3 years
Secondary outcomes:
measure: sphincter of oddi function
timeFrame: an expected average of 120 minutes
measure: Mortality
timeFrame: 90 days
measure: Biliary leakage
timeFrame: 90 days
measure: total bilirubin
timeFrame: 90 days
measure: quality of life grading
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Bao Fu Liu, PhD
role: STUDY_CHAIR
References:
citation: Chen JM, Yan XY, Zhu T, Chen ZX, Zhao YJ, Xie K, Liu FB, Geng XP. T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial. Trials. 2020 Jun 29;21(1):586. doi: 10.1186/s13063-020-04483-z.