Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis
Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis: a Randomized Controlled Trial
Changhai Hospital
158 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- Prior sphincter intervention.
- Not recovered from prior AP attack.
- Prior pancreatic surgery.
- Contraindications to ERCP.
- Major mental illness or serious health problems that are not suitable for participation in the study.
- Pregnancy or plan for pregnancy within 12 months of enrollment.
- Other conditions that inappropriate to participant in the study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will undergo ERCP and indomethacin will be administered rectally before procedure in participants with no known allergy to indomethacin. If the etiology of the participant is clearly defined during ERCP, the corresponding endoscopic treatment procedure will be performed. For others whose etiology are still unclear, pancreatic sphincterotomy and small caliber prophylactic pancreatic duct stent replacement will be performed. The participants will be observed closely after ERCP and record complications. Abdominal X-rays will be taken 2 weeks after ERCP to confirm spontaneous passage of the pancreatic duct stent, and the stent will be removed via gastroscopy if it still in place.
Participants will be given health education and conservative management of clinical routines. Clinical management is based on the pancreatic endocrine and exocrine function.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06364397