Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218669
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
xpgeng, The Second Hospital of Anhui Medical University

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients 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
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 30, 2025

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.




Primary Outcome Measures :
  1. 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. (%)

  2. biliary stricturer rate [ Time Frame: 3 years ]
    Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)

  3. Cholangitis rate [ Time Frame: 3 years ]
    The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)


Secondary Outcome Measures :
  1. 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

  2. Mortality [ Time Frame: 90 days ]
    Operative mortality was defined as any death resulting from a complication during surgery

  3. 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

  4. total bilirubin [ Time Frame: 90 days ]
    serum total bilirubin on 3 postoperative day (umol/L)

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Bao F Liu, doctor +8613515662646 liufubao88@163.com
Contact: Ming J Chen, doctor +8615855518651 chenjm10@126.com

Sponsors and Collaborators
xpgeng
Investigators
Layout table for investigator information
Study Chair: Bao Fu Liu, PhD The First Affiliated Hospital of Anhui Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: xpgeng, professor, The Second Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT04218669    
Other Study ID Numbers: 1804h08020239
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by xpgeng, The Second Hospital of Anhui Medical University:
sphincter of Oddi laxity
hepatolithiasis
choledochojejunostomy