Evaluating ERCP for treating idiopathic recurrent acute pancreatitis
Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis: a Randomized Controlled Trial
This study is testing if a procedure called ERCP can help adults with unexplained repeated bouts of pancreatitis feel better and have fewer episodes compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06364397 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the effectiveness of endoscopic retrograde cholangiopancreatography (ERCP) in treating idiopathic recurrent acute pancreatitis (IRAP) in adults. Participants will be randomly assigned to receive either ERCP, which includes pancreatic sphincterotomy and stent placement, or conservative treatment. The study will assess whether ERCP can reduce the frequency of pancreatitis episodes and help identify the underlying causes of IRAP. Participants will be monitored for one year to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have experienced two or more episodes of acute pancreatitis with no identifiable cause after thorough clinical investigations.
Not a fit: Patients who have had prior sphincter interventions, are not fully recovered from a previous acute pancreatitis attack, or have contraindications to ERCP may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that significantly reduces the frequency of pancreatitis episodes in patients with idiopathic recurrent acute pancreatitis.
How similar studies have performed: While there is limited high-quality evidence on the use of ERCP for IRAP, previous smaller studies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 to 70 years. 2. Patients diagnosed with IRAP: 1. 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. 2. 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. 3. At least 1 episode of AP one year prior to enrollment. 4. Consent to participate in the study and sign the informed consent form. Exclusion Criteria: 1. Prior sphincter intervention. 2. Not recovered from prior AP attack. 3. Prior pancreatic surgery. 4. Contraindications to ERCP. 5. Major mental illness or serious health problems that are not suitable for participation in the study. 6. Pregnancy or plan for pregnancy within 12 months of enrollment. 7. Other conditions that inappropriate to participant in the study.
Where this trial is running
Shanghai, Shanghai Municipality
- Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lianghao Hu, M.D.
- Email: lianghao-hu@smmu.edu.cn
- Phone: +86-13817593520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.