TY - JOUR
T1 - A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity
AU - Thiruvengadam, Nikhil R.
AU - Kouanda, Abdul
AU - Kalluri, Anita
AU - Schaubel, Douglas
AU - Saumoy, Monica
AU - Forde, Kimberly
AU - Song, Jun
AU - Faggen, Alec
AU - Davis, Brenton G.
AU - Onwugaje, Kenechukwu Chudy
AU - Cote, Gregory
AU - Arain, Mustafa A.
AU - Kochman, Michael L.
N1 - Publisher Copyright:
© 2023 AGA Institute
PY - 2023/5
Y1 - 2023/5
N2 - Background & Aims: The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-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 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM. Results: A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM. Conclusions: 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. ClinicalTrials.gov number, NCT05310409.
AB - Background & Aims: The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-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 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM. Results: A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM. Conclusions: 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. ClinicalTrials.gov number, NCT05310409.
KW - Cotton Consensus Criteria
KW - PAN-PROMISE
KW - Patient-reported Outcome Measure
KW - Post-ERCP Morbidity
KW - Post-ERCP Pancreatitis
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U2 - 10.1016/j.cgh.2022.08.034
DO - 10.1016/j.cgh.2022.08.034
M3 - Article
C2 - 36075501
AN - SCOPUS:85146972355
SN - 1542-3565
VL - 21
SP - 1233-1242.e14
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 5
ER -