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

The Role of Roux-en-Y Hepaticojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity: an Open-label Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sphincter of Oddi Dysfunction; Hepatolithiasis
• Intervention / Treatment: Procedure: Roux-en-Y hepaticojejunostomy

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Zhejiang University school of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; The common bile duct will be maintained for bile drainage in the control arm.
Experimental: Trial arm; Roux-en-Y hepaticojejunostomy will be performed for bile drainage in the trial arm.	Procedure: Roux-en-Y hepaticojejunostomy; All participants received routine perioperative care and followed the same surgical principles: removing affected liver segments, clearing stones, correcting strictures, and then restoring bile drainage. The primary indications for hepatectomy were unilobar or segmental diseases and the presence of the following lesions in the affected liver segment or lobe: 1) multiple stones with biliary strictures that cannot be cured via choledochoscopy, 2) atrophy, fibrosis, and multiple abscesses, and 3) suspicious neoplasia. Biliary exploration was routinely conducted to facilitate stone removal, rectify strictures, and assess the functionality of the Oddi sphincter. Following this, patients would be evaluated for eligibility and assigned accordingly. The sole distinction between the two arms was performing RYHJ or maintaining the common bile duct for bile drainage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of stones, including residual and recurrent stones, within three years postoperatively.	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.	A three-year postoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complications	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.	perioperation
Episodes of cholangitis	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.	3-year follow-up period
Invasive re-interventions for stones and related complications	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.	3-year follow-up period
Postoperative hospital stays	Hospital stays arising during unplanned readmission were also taken into account	perioperation
Medical expenses	Medical expenses covered all costs incurred throughout the course, including planned choledochoscopy and unplanned readmissions.	perioperation
Unplanned readmission within 30 days postoperatively		perioperation

Other Outcome Measures

Outcome Measure	Time Frame
Cholangiocarcinoma arising	3-year follow-up period

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2010
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimated): October 25, 2011

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; Sphincter of Oddi Dysfunction; Hepatolithiasis; Roux-en-Y hepaticojejunostomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Dyskinesia; Common Bile Duct Diseases; Sphincter of Oddi Dysfunction
• Other Study ID Numbers: ZYYYSOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No