PancreatitisNCT07455227
ERCP Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.
A study testing ERCP in people with Pancreatitis, run by Fu Jen Catholic University Hospital.
Trial summary
to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of gallstone-related pancreatitis (classified as mild pancreatitis according to the 2012 revised Atlanta classification and definitions).
- Imaging studies reveal the presence of gallstones or sludge, along with at least one of the following conditions: i. Imaging evidence of common bile duct dilation (common bile duct diameter > 8 mm for patients aged ≤ 75 years; > 10 mm for patients aged > 75 years).
- Biochemical evidence of cholestasis with total bilirubin levels between 1.8 - 4 mg/dL.
- Alanine aminotransferase (ALT) levels greater than twice the upper limit of normal.
- -
Who cannot join
None listed.
About this study
Official title: Comparison of Endoscopic Sphincterotomy and Conservative Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.
to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis.
- Conditions
- Pancreatitis
- Being tested
- ERCP
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
ERPC endoscopic sphictotomy
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | Not described |
| ERCP | Experimental | Not described Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent pancreatitis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455227
- Sponsor's protocol ID
- Biliary01
- Status last verified
- May 2025
- First submitted
- 3 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Sphincterotomy and Conservative Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07455227
- Acronym / sponsor ID
- Biliary01
- Conditions
- Pancreatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- 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.
to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | – |
| ERCP | Experimental | Procedure: ERCP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of gallstone-related pancreatitis (classified as mild pancreatitis according to the 2012 revised Atlanta classification and definitions).
- Imaging studies reveal the presence of gallstones or sludge, along with at least one of the following conditions: i. Imaging evidence of common bile duct dilation (common bile duct diameter > 8 mm for patients aged ≤ 75 years; > 10 mm for patients aged > 75 years).
- Biochemical evidence of cholestasis with total bilirubin levels between 1.8 - 4 mg/dL.
- Alanine aminotransferase (ALT) levels greater than twice the upper limit of normal.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ERCPERPC endoscopic sphictotomy | Procedure or surgery | ERCP |
Primary outcome
recurrent pancreatitis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP in people with Pancreatitis, run by Fu Jen Catholic University Hospital.
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 5 inclusion and 0 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
recurrent pancreatitis (time frame: 1 year). 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 6 Mar 2026.