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

NCT06364397 | Recruiting DMC

• 1 other identifier: ESPRIT202403
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Acute Pancreatitis

Keywords

Recurrent acute pancreatitis; Idiopathic; ERCP; Sphincterotomy

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year after enrollment

Secondary Outcomes (6)

• Ratio of reduced AP episodes

  1 year after enrollment

• Proportion of patients with reduced AP episodes

  1 year after enrollment

• Severity of AP

  1 year after enrollment

• Evaluation of quality of life

  1 year after enrollment

• Evaluation of psychological condition

  1 year after enrollment

Study Arms (2)

ERCP group

EXPERIMENTAL

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; Combination Product: Health education and conservative management of clinical routines

conservative treatment group

ACTIVE COMPARATOR

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

Interventions

ERCP PROCEDURE

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.

ERCP group

Health education and conservative management of clinical routines COMBINATION_PRODUCT

Participants will be given health education and conservative management of clinical routines. Clinical management is based on the pancreatic endocrine and exocrine function.

ERCP group; conservative treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead
• Peking Union Medical College Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (8)

• Guda NM, Trikudanathan G, Freeman ML. Idiopathic recurrent acute pancreatitis. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):720-728. doi: 10.1016/S2468-1253(18)30211-5.

  PMID: 30215363 BACKGROUND

• Machicado JD, Yadav D. Epidemiology of Recurrent Acute and Chronic Pancreatitis: Similarities and Differences. Dig Dis Sci. 2017 Jul;62(7):1683-1691. doi: 10.1007/s10620-017-4510-5. Epub 2017 Mar 9.

  PMID: 28281168 BACKGROUND

• Sankaran SJ, Xiao AY, Wu LM, Windsor JA, Forsmark CE, Petrov MS. Frequency of progression from acute to chronic pancreatitis and risk factors: a meta-analysis. Gastroenterology. 2015 Nov;149(6):1490-1500.e1. doi: 10.1053/j.gastro.2015.07.066. Epub 2015 Aug 20.

  PMID: 26299411 BACKGROUND

• Ahmed Ali U, Issa Y, Hagenaars JC, Bakker OJ, van Goor H, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Brink MA, Schaapherder AF, Dejong CH, Spanier BW, Heisterkamp J, van der Harst E, van Eijck CH, Besselink MG, Gooszen HG, van Santvoort HC, Boermeester MA; Dutch Pancreatitis Study Group. Risk of Recurrent Pancreatitis and Progression to Chronic Pancreatitis After a First Episode of Acute Pancreatitis. Clin Gastroenterol Hepatol. 2016 May;14(5):738-46. doi: 10.1016/j.cgh.2015.12.040. Epub 2016 Jan 6.

  PMID: 26772149 BACKGROUND

• Jacob L, Geenen JE, Catalano MF, Geenen DJ. Prevention of pancreatitis in patients with idiopathic recurrent pancreatitis: a prospective nonblinded randomized study using endoscopic stents. Endoscopy. 2001 Jul;33(7):559-62. doi: 10.1055/s-2001-15314.

  PMID: 11473324 BACKGROUND

• Cote GA, Imperiale TF, Schmidt SE, Fogel E, Lehman G, McHenry L, Watkins J, Sherman S. Similar efficacies of biliary, with or without pancreatic, sphincterotomy in treatment of idiopathic recurrent acute pancreatitis. Gastroenterology. 2012 Dec;143(6):1502-1509.e1. doi: 10.1053/j.gastro.2012.09.006. Epub 2012 Sep 11.

  PMID: 22982183 BACKGROUND

• Strand DS, Law RJ, Yang D, Elmunzer BJ. AGA Clinical Practice Update on the Endoscopic Approach to Recurrent Acute and Chronic Pancreatitis: Expert Review. Gastroenterology. 2022 Oct;163(4):1107-1114. doi: 10.1053/j.gastro.2022.07.079. Epub 2022 Aug 22.

  PMID: 36008176 BACKGROUND

• Wehrmann T. Long-term results (>/= 10 years) of endoscopic therapy for sphincter of Oddi dysfunction in patients with acute recurrent pancreatitis. Endoscopy. 2011 Mar;43(3):202-7. doi: 10.1055/s-0030-1255922. Epub 2010 Nov 24.

  PMID: 21108172 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zhaoshen Li, M.D.

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Lianghao Hu, M.D.

CONTACT

+86-13817593520; lianghao-hu@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 15, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)