Roux-en-Y Hepaticojejunostomy for Hepatolithiasis With Sphincter of Oddi Laxity

Not Applicable

Completed

• Conditions: Hepatolithiasis; Sphincter of Oddi Dysfunction

• Registration Number: NCT01459549
• Lead Sponsor: Zhejiang University

Brief Summary

Objective: Evaluate the role of Roux-en-Y hepaticojejunostomy (RYHJ) in hepatolithiasis patients with sphincter of Oddi laxity (SOL).

Summary Background Data: Hepatolithiasis poses high risks of residual, recurrence, and re-intervention. SOL significantly impacts this condition. RYHJ has been recommended for hepatolithiasis concomitant SOL but without prospective evidence.

Methods: This is an open-label randomized controlled trial recruiting patients with hepatolithiasis concurrent SOL. Patients were randomly assigned (1:1) to undergo RYHJ or not. The primary endpoint was stone occurrence, including residual and recurrence, within a three-year postoperative period. Secondary endpoints incorporated perioperative and long-term outcomes, like episodes of cholangitis and invasive re-interventions for stones and related complications. The analyses followed the intention-to-treat principle.

Detailed Description

Hepatolithiasis (HL) is prevalent in East Asia, especially in China. While this condition results from multiple etiological factors, obstructive cholangitis is usually the main cause. In our clinical experience, the investigators have found few cases with obstruction of the common bile duct or sphincter of Oddi; to the contrary, almost half of our clinical cases showed sphincter of Oddi laxity (SOL). SOL results in reflux of duodenal fluid and Escherichia coli (E. coli) infection, which lead to the formation of stones in the biliary tract. Thus, HL tends to recur in SOL patients. For these patients, Roux-en-Y choledochojejunostomy(choledochojejunostomy with an anti-reflux ansa intestinalis) may be the most promising therapy.

Study Timeline

• Study Start: 2010-12-13
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. aged between 18 and 80 years
2. diagnosed with SOL during operation
3. suitable for a radical surgery including RYHJ
4. hopeful to clear stones via operation or combined with subsequent choledochoscopy
5. provided written informed consent
6. willing to complete a 3-year follow-up

An intraoperative diagnosis of SOL was established if the rhythmic contraction and relaxation of the sphincter of Oddi were not observed under choledochoscope and the flexible choledochoscope (CHF-P20, external diameter, 4.9 mm; Olympus, Tokyo, Japan) could navigate smoothly to the duodenum through the sphincter of Oddi without any pre-dilation interventions.

Exclusion Criteria

1. with imaging evidences of tumor preoperatively
2. had congenital biliary malformations
3. had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of stones, including residual and recurrent stones, within three years postoperatively.	A three-year postoperative period	The term "stone occurrence" pertained to the identification of any bile duct stones with the most reliable imaging modality available during the follow-up period. "Stone residual" described a patient in whom stones were detected during the initial follow-up examination, while "stone recurrence" referred to a patient who exhibited no stones at the first follow-up visit but subsequently presented with stones during later follow-up assessments.

Secondary Outcome Measures

Name	Time	Method
Medical expenses	perioperation	Medical expenses covered all costs incurred throughout the course, including planned choledochoscopy and unplanned readmissions.
Unplanned readmission within 30 days postoperatively	perioperation
Major complications	perioperation	Postoperative complications were graded according to the Clavien-Dindo definition and those ranked Grade III or above were defined as major complications. Complications arising during unplanned readmission were also taken into account.
Episodes of cholangitis	3-year follow-up period	Episodes of cholangitis, regardless of definite or suspected one. The diagnosis of cholangitis were initially established according to the Tokyo 2007 guidelines and were subsequently revised following the Tokyo 2018 guidelines.
Invasive re-interventions for stones and related complications	3-year follow-up period	The term "invasive re-interventions" covered operation, percutaneous transhepatic cholangioscopy, and endoscopic retrograde cholangiopancreatography. The planned choledochoscopy following the initial surgical procedure was not lumped into invasive re-interventions.
Postoperative hospital stays	perioperation	Hospital stays arising during unplanned readmission were also taken into account

Trial Locations

Locations (1)

Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China