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.
Aged 18 to 70 years.
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.
Prior sphincter intervention.
Not recovered from prior AP attack.
Prior pancreatic surgery.
Contraindications to ERCP.
Parallel
ERCP
Procedure/SurgeryParticipants 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.
Health education and conservative management of clinical routines
Combination productParticipants will be given health education and conservative management of clinical routines. Clinical management is based on the pancreatic endocrine and exocrine function.
Recurrence rate of AP
Proportion of patients with at least one episode of AP 1 year after enrollment (AP within 1 month of the index ERCP was excluded).
Ratio of reduced AP episodes
Ratio of the reduced AP episodes (1 year before and after enrollment) to the AP episodes in 1 year before enrollment. AP within 1 month of the index ERCP was excluded.
Proportion of patients with reduced AP episodes
Proportion of patients whose AP episodes reduced (1 year before and after enrollment). AP within 1 month of the index ERCP was excluded.
Severity of AP
Proportion of patients with different severity of AP that according to the Atlanta criteria.
Evaluation of quality of life
Evaluate by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) that measures health on eight dimensions. For each dimension, item scores are coded, summed, and transformed into a scale from 0 (worst health) to 100 (best health).
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Changhai Hospital
Lead sponsor
Peking Union Medical College Hospital
Collaborator
First People's Hospital of Hangzhou
Collaborator
