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

Sponsor

xpgeng (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04218669

Collaborator

(none)

105

Enrollment

Arms

70.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sphincter of Oddi Laxity	Procedure: Roux-en-Y Hepaticojejunostomy Procedure: T-tube drainage	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients were randomized to choledochojejunostomy arm or T tube drainage armPatients were randomized to choledochojejunostomy arm or T tube drainage arm

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Blinding of the surgeons and patients is not feasible due to the obviously different characteristics of the two types of biliary drainage. Investigator and outcome assessors will be blinded to the trial intervention.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
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)
quality of life grading [3 years]
Quality of life will be assessed by Visick score (Ⅰ～Ⅳ).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

xpgeng

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

xpgeng, professor, The Second Hospital of Anhui Medical University

ClinicalTrials.gov Identifier:

NCT04218669

Other Study ID Numbers:

1804h08020239

First Posted:

Jan 6, 2020

Last Update Posted:

Jan 6, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by xpgeng, professor, The Second Hospital of Anhui Medical University

sphincter of Oddi laxity

hepatolithiasis

choledochojejunostomy

Study Results

No Results Posted as of Jan 6, 2020