HepatolithiasisNCT01459549
Roux-en-Y Hepaticojejunostomy for Hepatolithiasis With Sphincter of Oddi Laxity
A study testing Roux-en-Y hepaticojejunostomy in people with Hepatolithiasis and Sphincter of Oddi Dysfunction, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatolithiasis, Sphincter of Oddi Dysfunction
- What is being tested?
- Roux-en-Y hepaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2010to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- with imaging evidences of tumor preoperatively
- had congenital biliary malformations
- had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatolithiasis, Sphincter of Oddi Dysfunction
- Being tested
- Roux-en-Y hepaticojejunostomy
- Keywords
- Hepatolithiasis, Sphincter of Oddi Dysfunction, Roux-en-Y hepaticojejunostomy, randomized controlled trial
- Medical subject headings
- Sphincter of Oddi Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y hepaticojejunostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | The common bile duct will be maintained for bile drainage in the control arm. |
| Trial arm | Experimental | Roux-en-Y hepaticojejunostomy will be performed for bile drainage in the trial arm. Receives: Procedure: Roux-en-Y hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A three-year postoperative period
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 3-year follow-up period
Postoperative hospital stays
Hospital stays arising during unplanned readmission were also taken into account
Measured: perioperation
Medical expenses
Medical expenses covered all costs incurred throughout the course, including planned choledochoscopy and unplanned readmissions.
Measured: perioperation
Unplanned readmission within 30 days postoperatively
Measured: perioperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study start13 Dec 2010
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatolithiasisStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459549
- Sponsor's protocol ID
- ZYYYSOL
- Status last verified
- Jul 2025
- First submitted
- 21 Oct 2011
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Roux-en-Y Hepaticojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity: an Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01459549
- Acronym / sponsor ID
- ZYYYSOL
- Conditions
- Hepatolithiasis, Sphincter of Oddi Dysfunction
- Keywords
- Hepatolithiasis, Sphincter of Oddi Dysfunction, Roux-en-Y hepaticojejunostomy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 13 Dec 2010 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –The common bile duct will be maintained for bile drainage in the control arm. |
| Trial arm | Experimental | Procedure: Roux-en-Y hepaticojejunostomyRoux-en-Y hepaticojejunostomy will be performed for bile drainage in the trial arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- with imaging evidences of tumor preoperatively
- had congenital biliary malformations
- had ever received biliary operation abandoning the Oddi sphincter, such as choledochoduodenostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y hepaticojejunostomyAll 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. | Procedure or surgery | Trial arm |
Primary outcome
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.
6 secondary outcomes
Major complications
Time frame: perioperation
Episodes of cholangitis
Time frame: 3-year follow-up period
Invasive re-interventions for stones and related complications
Time frame: 3-year follow-up period
Postoperative hospital stays
Time frame: perioperation
Medical expenses
Time frame: perioperation
Unplanned readmission within 30 days postoperatively
Time frame: perioperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y hepaticojejunostomy in people with Hepatolithiasis and Sphincter of Oddi Dysfunction, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of stones, including residual and recurrent stones, within three years postoperatively. (time frame: A three-year postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.