Clinical trial NCT05310409: PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms
Official title: A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-Reported Outcome Measure, To Detect and Risk-Stratify Post-ERCP Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are enrolling patients who are undergoing ERCP at our two centers.

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.

Detailed description: This project will measure the impact of a recently validated patient-reported outcome measure for acute pancreatitis, PAN-PROMISE, to detect post-ERCP pancreatitis symptoms and capture its morbidity. The study will compare the change of PAN-PROMISE before and after ERCP to the current standard diagnostic criteria for post-ERCP pancreatitis, the Cotton Consensus Criteria. The main limitations of the Cotton-Consensus Criteria are that it fails to capture outpatient or ambulatory morbidity, uses length of stay to define the severity of pancreatitis without accounting for local or systemic complications for pancreatitis, and it has limited sensitivity in patients with chronic symptoms such as patients with chronic pancreatitis or pancreatic adenocarcinoma. These limitations have impeded the evaluation of potential therapies to prevent post-ERCP pancreatitis. PAN-PROMISE will help capture and quantitate the morbidity related to post-ERCP pancreatitis and thus will enhance our ability to optimize outcomes following ERCP.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing ERCP
2. Age \>= 18 years old
3. Intact major papilla

Exclusion Criteria:

1. Unwillingness or inability to consent for the study
2. Age \< 18 years
3. Standard contraindications to ERCP
4. Intrauterine pregnancy
5. Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication
6. Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication
7. Low probability of completing the follow-up
8. Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.
9. Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.
10. Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.
11. 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.

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 7 days after ERCP
measure: PROM-PEP
timeFrame: 30 days
Secondary outcomes:
measure: Direct Health Care Costs
timeFrame: 30 days
Other outcomes:
measure: Quality of Life Assessment
timeFrame: 30 days
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael L Kochman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Mustafa Arain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University School of Medicine.
name: Nikhil R Thiruvengadam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.