UnknownNot Applicable

Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis

China158 participantsStarted 2024-07-01

Plain-language summary

The goal of this clinical trial is to learn if endoscopic retrograde cholangiopancreatography (ERCP) works to treat idiopathic recurrent pancreatitis (IRAP) in adults. It also clarify the efficacy of ERCP in the diagnosis of IRAP. The main questions it aims to answer are: Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients? Does ERCP contribute to identify the etiology of IRAP patients? Participants will be randomly allocated to receive ERCP (pancreatic sphincterotomy and pancreatic stent placement) or conservative treatment and be followed for 1 year.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 18 to 70 years.
. Patients diagnosed with IRAP:
. Previously experienced 2 or more distinct episodes of acute pancreatitis (AP) with complete resolution between each episode, and absence of irreversible structural and functional changes in pancreas. The diagnosis of AP is based on the Atlanta criteria and is documented in the medical record.
. The etiology of RAP remains undetermined after routine clinical investigations, including history, laboratory examination, imaging examination (CT, MRI/MRCP, EUS). Patients who still have AP episodes after elimination of the etiology also be included.
. At least 1 episode of AP one year prior to enrollment.
. Consent to participate in the study and sign the informed consent form.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence rate of AP

Timeframe: 1 year after enrollment

Trial details

NCT IDNCT06364397

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Lianghao Hu, M.D.

+86-13817593520 lianghao-hu@smmu.edu.cn

View on ClinicalTrials.gov More Recurrent Acute Pancreatitis trials