E0003 - A Prospective Cohort Study Evaluating Pan-Promise: A Patient-Reported Outcome Measure to Detect Post-ERCP Pancreatitis Symptoms

Nikhil R. Thiruvengadam, MD¹, Abdul Kouanda, MD², Anita Kalluri, BS³, Douglas Schaubel, PhD⁴, Monica Saumoy, MD, MS⁵, Kimberly Forde, MD, PhD⁶, Jun Song, MD⁷, Kenechukwu Chudy-Onwugaje, MD, MPH⁸, Brenton Davis, MD², Alec Faggen, MD², Gregory Cote, MD, MS⁹, Mustafa Arain, MD², Michael Kochman, MD^4
1Loma Linda University Medical Center, Yorba Linda, CA; ²UCSF Medical Center, San Francisco, CA; ³University of Pennsylvania School of Medicine, Baltimore, MD; ⁴University of Pennsylvania, Philadelphia, PA; ⁵Center for Digestive Health, Penn Princeton Medical Center, Princeton, NJ; ⁶Temple University, Philadelphia, PA; ⁷Temple University Hospital, Philadelphia, PA; ⁸BJC Healthcare, St. Louis, MO; ⁹Oregon Health & Science University, Portland, OR

Introduction: The Cotton Consensus (CC) criteria for post-ERCP pancreatitis (PEP) may not capture post-ERCP morbidity and uses length of stay to define severity. PAN-PROMISE, a patient-reported outcome measure, was developed to quantify AP-related morbidity. This study aims to determine the value of PAN-PROMISE in independently defining ERCP-related morbidity.

Methods: We conducted a prospective cohort study of patients undergoing ERCP at two academic centers from 09/2021 to 08/2022. We administered PAN-PROMISE and assessed QOL and work-productivity at baseline, 48-72 hours, seven days, and 30 days following ERCP. Patients also received a standardized telephone call to assess for the CC criteria. CC-PEP was determined by a blinded, three-physician adjudication committee. The McNemar's test assessed discordance between matched pairs of CC-PEP and changes in PAN-PROMISE > 7 at 7 days. After enrollment of 150 patients, an interim analysis using ROC analysis identified that the optimal cutpoint in a change of PAN-PROMISE was an increase of >7 points (sensitivity 83%, specificity 78%, AUC 0.85)

Results: 679 patients were enrolled (Median age 63, 55% male, 55% had a history of cancer). The indications for ERCP were choledocholithiasis (30%), malignant biliary obstruction (29%), and liver transplant (14%). 95% of patients received rectal indomethacin. 32 (4.7%) patients developed PEP. 147 (21.6%) patients had an elevated-PROM, while only 20 (13.4%) of them had PEP by the CC criteria (p< 0.001 for discordance). An elevated-PROM strongly correlated with lower physical QOL and increased direct and indirect healthcare costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (OR 4.52 95%-CI 1.68-10.74) and PSC (OR 1.79 95%-CI 1.29-2.45) had the highest odds of elevated-PROM.

Discussion: A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP.




Disclosures:


Nikhil R. Thiruvengadam, MD¹, Abdul Kouanda, MD², Anita Kalluri, BS³, Douglas Schaubel, PhD⁴, Monica Saumoy, MD, MS⁵, Kimberly Forde, MD, PhD⁶, Jun Song, MD⁷, Kenechukwu Chudy-Onwugaje, MD, MPH⁸, Brenton Davis, MD², Alec Faggen, MD², Gregory Cote, MD, MS⁹, Mustafa Arain, MD², Michael Kochman, MD⁴. E0003 - A Prospective Cohort Study Evaluating Pan-Promise: A Patient-Reported Outcome Measure to Detect Post-ERCP Pancreatitis Symptoms, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.