Clinical trial NCT01459549: Roux-en-Y Hepaticojejunostomy for Hepatolithiasis With Sphincter of Oddi Laxity
Official title: The Role of Roux-en-Y Hepaticojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatolithiasis
Sphincter of Oddi Dysfunction
Keywords: Hepatolithiasis
Sphincter of Oddi Dysfunction
Roux-en-Y hepaticojejunostomy
randomized controlled trial
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of stones, including residual and recurrent stones, within three years postoperatively.
timeFrame: A three-year postoperative period
Secondary outcomes:
measure: Major complications
timeFrame: perioperation
measure: Episodes of cholangitis
timeFrame: 3-year follow-up period
measure: Invasive re-interventions for stones and related complications
timeFrame: 3-year follow-up period
measure: Postoperative hospital stays
timeFrame: perioperation
measure: Medical expenses
timeFrame: perioperation
measure: Unplanned readmission within 30 days postoperatively
timeFrame: perioperation
Other outcomes:
measure: Cholangiocarcinoma arising
timeFrame: 3-year follow-up period
Locations:
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: