PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

NCT05310409 | Completed

• 1 other identifier: PAN-PROMISE
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (2)

• Post-ERCP Pancreatitis

  will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.

  7 days after ERCP

• PROM-PEP

  will capture the work abseentism and loss of productivity using the Work-Productivity and Activity Impairment Questionnaire and will express in in 2021 US Dollars.

  30 days

Secondary Outcomes (1)

• Direct Health Care Costs

  30 days

Other Outcomes (1)

• Quality of Life Assessment

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We are enrolling patients who are undergoing ERCP at our two centers.

You may qualify if:

• Patients undergoing ERCP
• Age \>= 18 years old
• Intact major papilla

You may not qualify if:

• Unwillingness or inability to consent for the study
• Age \< 18 years
• Standard contraindications to ERCP
• Intrauterine pregnancy
• Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication
• Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication
• Low probability of completing the follow-up
• Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.
• Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.
• Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.
• Patients who speak a language other than English, Spanish, Bulgarian, Mandarin, English, French, German, Greek, Hungarian, Italian, Korean, Polish, Portuguese, Romanian, Russian, Turkish, Ukrainian, or Hindi (as the PAN-PROMISE has only been translated and validated in these languages.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, Minoli G, Crosta C, Comin U, Fertitta A, Prada A, Passoni GR, Testoni PA. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol. 2001 Feb;96(2):417-23. doi: 10.1111/j.1572-0241.2001.03594.x.

  PMID: 11232684 BACKGROUND

• Artifon EL, Chu A, Freeman M, Sakai P, Usmani A, Kumar A. A comparison of the consensus and clinical definitions of pancreatitis with a proposal to redefine post-endoscopic retrograde cholangiopancreatography pancreatitis. Pancreas. 2010 May;39(4):530-5. doi: 10.1097/MPA.0b013e3181c306c0.

  PMID: 20093992 BACKGROUND

• Thiruvengadam NR, Forde KA, Ma GK, Ahmad N, Chandrasekhara V, Ginsberg GG, Ho IK, Jaffe D, Panganamamula KV, Kochman ML. Rectal Indomethacin Reduces Pancreatitis in High- and Low-Risk Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2016 Aug;151(2):288-297.e4. doi: 10.1053/j.gastro.2016.04.048. Epub 2016 May 20.

  PMID: 27215656 BACKGROUND

• de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.

  PMID: 32245906 BACKGROUND

• Thiruvengadam NR, Kouanda A, Kalluri A, Schaubel D, Saumoy M, Forde K, Song J, Faggen A, Davis BG, Onwugaje KC, Cote G, Arain MA, Kochman ML. A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity. Clin Gastroenterol Hepatol. 2023 May;21(5):1233-1242.e14. doi: 10.1016/j.cgh.2022.08.034. Epub 2022 Sep 6.

  PMID: 36075501 DERIVED

Study Officials

• Michael L Kochman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Mustafa Arain, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nikhil R Thiruvengadam, MD

  Loma Linda University School of Medicine.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: September 15, 2020
• Primary Completion: August 1, 2021
• Study Completion: January 1, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)