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

Sphincter of Oddi Laxity Clinical Trial

— BD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04218669
• Other study ID #: 1804h08020239
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2020
• Source: The Second Hospital of Anhui Medical University
• Contact: Bao F Liu, doctor
• Phone: +8613515662646
• Email: liufubao88[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sphincter of Oddi Laxity

Intervention

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 ? 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.
• T-tube drainage
The T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
xpgeng

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone recurrence rate	A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)	3 years
Primary	biliary stricturer rate	Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)	3 years
Primary	Cholangitis rate	The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)	3 years
Secondary	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
Secondary	Mortality	Operative mortality was defined as any death resulting from a complication during surgery	90 days
Secondary	Biliary leakage	Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems	90 days
Secondary	total bilirubin	serum total bilirubin on 3 postoperative day (umol/L)	90 days
Secondary	quality of life grading	Quality of life will be assessed by Visick score (?~?).	3 years