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

NCT ID: NCT04218669

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2025-12-30

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.

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.

Conditions

Sphincter of Oddi Laxity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

T-tube drainage

The T-tube was placed for biliary drainage

Group Type: ACTIVE_COMPARATOR

T-tube drainage

Intervention Type: PROCEDURE

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

Roux-en-Y Hepaticojejunostomy

biliary-enteric anastomosis was performed

Group Type: EXPERIMENTAL

Roux-en-Y Hepaticojejunostomy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

xpgeng

OTHER

Sponsor Role: lead

Responsible Party

xpgeng

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bao Fu Liu, PhD

Role: STUDY_CHAIR

The First Affiliated Hospital of Anhui Medical University

Central Contacts

Bao F Liu, doctor

Role: CONTACT

liufubao88@163.com

+8613515662646

Ming J Chen, doctor

Role: CONTACT

chenjm10@126.com

+8615855518651

References

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.

Reference Type: DERIVED

PMID: 32600474 (View on PubMed)

Other Identifiers

1804h08020239

Identifier Type: -

Identifier Source: org_study_id