Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Lianghao Hu, M.D.
lianghao-hu@smmu.edu.cn
+86-13817593520
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 158
Treatments
Experimental: ERCP group
Participants will undergo ERCP. 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 accept health education and conservative management of clinical routines. Follow-up visits for participants occurred at 3, 6, 9 and 12 months after enrollment.
Active_comparator: conservative treatment group
Participants will be given health education and conservative management of clinical routines. Follow-up visits for participants occurred at 3, 6, 9 and 12 months after enrollment.
Sponsors
Collaborators: Peking Union Medical College Hospital, First People's Hospital of Hangzhou
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov