Idiopathic recurrent acute pancreatitis.
Nalini M Guda, Guru Trikudanathan, Martin L Freeman
https://pubmed.ncbi.nlm.nih.gov/30215363Actively Recruiting
Led by Changhai Hospital · Updated on 2024-07-12
158
Participants Needed
1
Research Sites
8 weeks
Total Duration
C
Changhai Hospital
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
Researchers are evaluating the use of endoscopic retrograde cholangiopancreatography (ERCP) to diagnose and treat idiopathic recurrent acute pancreatitis (IRAP) in adults. IRAP is a condition where patients have repeated episodes of acute pancreatitis without a clear cause, even after routine examinations. This study aims to find out if ERCP can reduce the number of pancreatitis episodes and help identify the cause of IRAP, addressing a current lack of high-quality evidence on this treatment. Participants will be randomly assigned to one of two groups: one group will receive ERCP treatment, which includes pancreatic sphincterotomy and placement of a small pancreatic stent. Indomethacin will be given rectally before the procedure for those without allergies. If the cause of pancreatitis is found during ERCP, appropriate endoscopic treatment will be performed. For participants without a clear cause, pancreatic sphincterotomy and stent placement will be done as a preventive measure. The other group will receive conservative treatment and health education. Follow-up visits will occur at 3, 6, 9, and 12 months after enrollment. During the study, participants will be closely monitored for complications after ERCP, including abdominal X-rays two weeks later to check stent passage, with removal if necessary. The main outcome measured will be the recurrence rate of acute pancreatitis one year after enrollment. Secondary measures include the reduction in pancreatitis episodes, severity of episodes, quality of life, psychological condition, and how often ERCP helps diagnose IRAP. The study lasts for one year, with regular follow-up to assess these outcomes.
CONDITIONS
Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial procedure and 2 weeks post-procedure monitoring
Participants in the ERCP group will undergo ERCP with indomethacin administered rectally before the procedure if no allergy is present. Depending on findings during ERCP, appropriate endoscopic treatment will be performed, or pancreatic sphincterotomy and stent placement will be done if the cause remains unclear. Participants will be closely observed after ERCP including abdominal X-rays 2 weeks post-procedure to check stent passage, with removal if necessary. Participants in the conservative treatment group will receive health education and conservative clinical management based on pancreatic function.
1 procedure visit and 1 follow-up visit 2 weeks later
Duration - 12 months
Participants in both groups will have follow-up visits to assess recurrence and clinical outcomes at 3, 6, 9, and 12 months after enrollment.
4 visits (in-person) at 3, 6, 9, and 12 months
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
L
Lianghao Hu, M.D.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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