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

April 17, 2024 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Recurrent acute pancreatitis (RAP) is defined as 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. RAP has an estimated annual incidence of 8-10 per 100,000 and the recurrence rate is as high as 10-30% in AP patients. At present, biliary, alcoholic and hypertriglyceridemia are common causes of RAP. There are also a variety of causes that may contribute to recurrent episodes of AP, such as gene mutations, pancreas divisum, ampullary neoplasms and sphincter of Oddi dysfunction. About 80% of RAP patients can be identified through routine clinical investigations (include proper history, physical examination, imaging examination); however, the etiology in up to 20% of cases still not be clarified and these patients is called idiopathic recurrent acute pancreatitis (IRAP).

Endoscopic retrograde cholangiopancreatography (ERCP) is an important minimally invasive treatment for pancreatic diseases. However, the role of ERCP in IRAP patients with normal biliary and pancreatic anatomy remains controversial and there is a lack of high-quality clinical research evidence on endoscopic treatment of IRAP. In a small sample size (N=34) open-label randomized controlled study, IRAP patients were assigned to the experimental group with pancreatic duct stent placement and the control group with selective pancreatograms but no stent. This study demonstrated that stent placement was able to reduce the recurrence rate of AP (53% vs 11%, P < 0.02). Coté et al performed an open-label randomized trial (N=89) of ERCP with sphincter of Oddi manometry for IRAP patients. Among patients with pancreatic sphincter dysfunction, they found that biliary sphincterotomy and combination of biliary and pancreatic sphincterotomy have similar effects in preventing recurrence of AP, and there was also no significant difference between biliary sphincterotomy and sham surgery in patients with normal sphincter of Oddi manometry. However, some retrospective studies had shown that sphincterotomy works to reduce the recurrence rate of acute pancreatitis.

Currently, there is a shortage of high-quality evidence, and the wide variation in different study designs has led to controversial conclusions. Given the long-standing controversy, we propose to conduct a randomized controlled trial to investigate the efficacy of ERCP in the diagnosis and treatment of Idiopathic recurrent acute pancreatitis.

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 70 years.

  2. Patients diagnosed with IRAP:

    1. 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.
    2. 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.
  3. At least 1 episode of AP one year prior to enrollment.
  4. Consent to participate in the study and sign the informed consent form.

Exclusion Criteria:

  1. Prior sphincter intervention.
  2. Not recovered from prior AP attack.
  3. Prior pancreatic surgery.
  4. Contraindications to ERCP.
  5. Major mental illness or serious health problems that are not suitable for participation in the study.
  6. Pregnancy or plan for pregnancy within 12 months of enrollment.
  7. Other conditions that inappropriate to participant in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: ERCP
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.
Combination product: Health education and conservative management of clinical routines
Participants will be given health education and conservative management of clinical routines. Clinical management is based on the pancreatic endocrine and exocrine function.
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.
Combination product: Health education and conservative management of clinical routines
Participants will be given health education and conservative management of clinical routines. Clinical management is based on the pancreatic endocrine and exocrine function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of AP
Time Frame: 1 year after enrollment
Proportion of patients with at least one episode of AP 1 year after enrollment (AP within 1 month of the index ERCP was excluded).
1 year after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of reduced AP episodes
Time Frame: 1 year after enrollment
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.
1 year after enrollment
Proportion of patients with reduced AP episodes
Time Frame: 1 year after enrollment
Proportion of patients whose AP episodes reduced (1 year before and after enrollment). AP within 1 month of the index ERCP was excluded.
1 year after enrollment
Severity of AP
Time Frame: 1 year after enrollment
Proportion of patients with different severity of AP that according to the Atlanta criteria.
1 year after enrollment
Evaluation of quality of life
Time Frame: 1 year after enrollment
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).
1 year after enrollment
Evaluation of psychological condition
Time Frame: 1 year after enrollment
Evaluate by the Depression Anxiety Stress Scale (DASS-21), which consists of 21 items with a total score of 0-63. The higher the score, the more serious the adverse psychological state of the patient.
1 year after enrollment
Proportion of patients diagnosed by ERCP.
Time Frame: 1 year after enrollment
Proportion of patients whose etiology was identified by ERCP.
1 year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

First People's Hospital of Hangzhou
Peking Union Medical College Hospital

Investigators

  • Study Chair: Zhaoshen Li, M.D., Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPRIT202403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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