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NCT Number: NCT01459549

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

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.

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Key information

Conditions

Hepatolithiasis Bile Duct Diseases Biliary Dyskinesia Biliary Tract Diseases Common Bile Duct Diseases Digestive System Diseases Sphincter of Oddi Dysfunction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 and 80 years
  • diagnosed with SOL during operation
  • suitable for a radical surgery including RYHJ
  • hopeful to clear stones via operation or combined with subsequent choledochoscopy
  • provided written informed consent
  • 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

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

Treatment and study plan

Roux-en-Y hepaticojejunostomy

Procedure

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.

Primary outcomes

  1. The incidence of stones, including residual and recurrent stones, within three years postoperatively.

    Time frame: 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 outcomes

  1. Major complications

    Time frame: 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.

  2. Episodes of cholangitis

    Time frame: 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.

  3. Invasive re-interventions for stones and related complications

    Time frame: 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.

  4. Postoperative hospital stays

    Time frame: perioperation

    Hospital stays arising during unplanned readmission were also taken into account

  5. Medical expenses

    Time frame: perioperation

    Medical expenses covered all costs incurred throughout the course, including planned choledochoscopy and unplanned readmissions.

  6. Unplanned readmission within 30 days postoperatively

    Time frame: perioperation

Other outcomes

  1. Cholangiocarcinoma arising

    Time frame: 3-year follow-up period

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2011
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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