Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06364397

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

Led by Changhai Hospital · Updated on 2024-07-12

158

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

C

Changhai Hospital

Lead Sponsor

P

Peking Union Medical College Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 70 years
  • Diagnosed with idiopathic recurrent acute pancreatitis (IRAP) defined by at least two separate acute pancreatitis episodes with full recovery between episodes
  • No irreversible structural or functional pancreatic changes
  • Unknown cause of recurrent acute pancreatitis after routine tests including history, labs, CT, MRI/MRCP, or EUS
  • At least one acute pancreatitis episode within one year prior to enrollment
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Previous sphincter intervention
  • Not fully recovered from a previous acute pancreatitis attack
  • Previous pancreatic surgery
  • Contraindications to ERCP
  • Major mental illness or serious health problems unsuitable for study participation
  • Pregnant or planning pregnancy within 12 months
  • Any other condition deemed inappropriate for study participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

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Research Team

L

Lianghao Hu, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Risk of Recurrent Pancreatitis and Progression to Chronic Pancreatitis After a First Episode of Acute Pancreatitis.

Usama Ahmed Ali, Yama Issa, Julia C Hagenaars...

https://pubmed.ncbi.nlm.nih.gov/26772149

Prevention of pancreatitis in patients with idiopathic recurrent pancreatitis: a prospective nonblinded randomized study using endoscopic stents.

L Jacob, J E Geenen, M F Catalano...

https://pubmed.ncbi.nlm.nih.gov/11473324

Similar efficacies of biliary, with or without pancreatic, sphincterotomy in treatment of idiopathic recurrent acute pancreatitis.

Gregory A Coté, Thomas F Imperiale, Suzette E Schmidt...

https://pubmed.ncbi.nlm.nih.gov/22982183