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

NCT04218669 | Unknown DMC

• 1 other identifier: 1804h08020239
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sphincter of Oddi Laxity

Keywords

sphincter of Oddi laxity; hepatolithiasis; choledochojejunostomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• sphincter of oddi function

  an expected average of 120 minutes

• Mortality

  90 days

• Biliary leakage

  90 days

• total bilirubin

  90 days

• quality of life grading

  3 years

Study Arms (2)

T-tube drainage

ACTIVE COMPARATOR

The T-tube was placed for biliary drainage

Procedure: T-tube drainage

Roux-en-Y Hepaticojejunostomy

EXPERIMENTAL

biliary-enteric anastomosis was performed

Procedure: Roux-en-Y Hepaticojejunostomy

Interventions

Roux-en-Y Hepaticojejunostomy PROCEDURE

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.

Roux-en-Y Hepaticojejunostomy

T-tube drainage PROCEDURE

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

T-tube drainage

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• xpgeng: lead

Related Publications (1)

• 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.

  PMID: 32600474 DERIVED

Study Officials

• Bao Fu Liu, PhD

  The First Affiliated Hospital of Anhui Medical University

  STUDY CHAIR

Central Study Contacts

Bao F Liu, doctor

CONTACT

+8613515662646; liufubao88@163.com

Ming J Chen, doctor

CONTACT

+8615855518651; chenjm10@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: Patients were randomized to choledochojejunostomy arm or T tube drainage arm

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 6, 2020
• Study Start: February 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 6, 2020

Record last verified: 2020-01