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

A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sphincter of Oddi Laxity
• Intervention / Treatment: Procedure: T-tube drainage; Procedure: Roux-en-Y Hepaticojejunostomy

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 Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bao F Liu, doctor; Phone Number: +8613515662646; Email: liufubao88@163.com
• Study Contact Backup: Name: Ming J Chen, doctor; Phone Number: +8615855518651; Email: chenjm10@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T-tube drainage; The T-tube was placed for biliary drainage	Procedure: T-tube drainage; The T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures.
Experimental: Roux-en-Y Hepaticojejunostomy; biliary-enteric anastomosis was performed	Procedure: Roux-en-Y Hepaticojejunostomy; The common hepatic duct was cut and the duodenal side is closed by suture. The small intestine was cut off 15 cm below the ligament of Treitz. The distal end was lifted, and a 1-2 cm incision was made at the jejunal wall 4-5 cm from the jejunal stump. The anastomosis is used a 5-0 PSD Ⅱ suture, with double needles, inside-out in the jejunum and outside-in in the hepatic duct. One side of needles was used to continuely penetrate and suture the whole layer of the posterior-lateral wall of the jejunum, the posterior-lateral wall of the biliary duct, and the other side of needles was used to continuely stuere the anterior part of the anastomosis. Mucosa-to-mucosa contact should be ensured with every stitch.The anastomotic stomas were then checked for leakage. Enteric-enteric anastomosis was performed 60 cm below the site of the hepatojejunal anastomosis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: xpgeng
• Investigators: Study Chair: Bao Fu Liu, PhD, The First Affiliated Hospital of Anhui Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hepatolithiasis; choledochojejunostomy; sphincter of Oddi laxity
• Other Study ID Numbers: 1804h08020239

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No