Status:
COMPLETED
Roux-en-Y Hepaticojejunostomy for Hepatolithiasis With Sphincter of Oddi Laxity
Lead Sponsor:
Zhejiang University
Conditions:
Hepatolithiasis
Sphincter of Oddi Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
NA
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 resi...
Eligibility Criteria
Inclusion
- 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
- with imaging evidences of tumor preoperatively
- had congenital biliary malformations
- had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy
Key Trial Info
Start Date :
December 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01459549
Start Date
December 13 2010
End Date
February 28 2022
Last Update
July 9 2025
Active Locations (1)
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1
Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003