The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity (BD)
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|ClinicalTrials.gov Identifier: NCT04218669|
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sphincter of Oddi Laxity||Procedure: Roux-en-Y Hepaticojejunostomy Procedure: T-tube drainage||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients were randomized to choledochojejunostomy arm or T tube drainage arm|
|Masking:||Double (Investigator, Outcomes Assessor)|
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.
|Official Title:||A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||September 30, 2025|
|Estimated Study Completion Date :||December 30, 2025|
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.
- stone recurrence rate [ Time Frame: 3 years ]A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)
- biliary stricturer rate [ Time Frame: 3 years ]Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)
- Cholangitis rate [ Time Frame: 3 years ]The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)
- sphincter of oddi function [ Time Frame: an expected average of 120 minutes ]Grading criteria for the SO function were as follows: Normal; Laxity and Loss of function
- Mortality [ Time Frame: 90 days ]Operative mortality was defined as any death resulting from a complication during surgery
- Biliary leakage [ Time Frame: 90 days ]Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
- total bilirubin [ Time Frame: 90 days ]serum total bilirubin on 3 postoperative day (umol/L)
- quality of life grading [ Time Frame: 3 years ]Quality of life will be assessed by Visick score (Ⅰ～Ⅳ).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218669
|Contact: Bao F Liu, firstname.lastname@example.org|
|Contact: Ming J Chen, email@example.com|
|Study Chair:||Bao Fu Liu, PhD||The First Affiliated Hospital of Anhui Medical University|