Biliary/Pancreas

1 - Rectal Indomethacin Dose Escalation for Prevention of Post-ERCP Pancreatitis in High-Risk Patients: Preliminary Report of a Multicenter Randomized Trial (RIDE Trial)

Monday, October 8
8:00 AM - 8:12 AM
Location: Terrace Ballroom (level 400)

Category: Biliary/Pancreas
Evan L. Fogel, MD, MSc1, Glen A. Lehman, MD, FACG1, Paul Tarnasky, MD, FACG2, Gregory A. Cote, MD, MSCI3, Richard Kwon, MD4, James L. Watkins, MD1, Suzette E. Schmidt, RN, BSN1, Stuart Sherman, MD, FACG1, Grace H. Elta, MD, FACG4, Jeffrey J. Easler, MD1, Douglas K. Pleskow, MD, FACG5, Ihab I. El Hajj, MD, MPH1, Akbar K. Waljee, MD, MSc4, Nalini M. Guda, MD, FACG6, Mark A. Gromski, MD7, Seena Arol, MBBS2, Sheryl Korsnes, MA, CCRC4, Lee McHenry, Jr., MD1, Alejandro L. Suarez, MD8, Rebecca Spitzer, MPH3, Marilyn MIller, RN, CCRC9, Maria Hofbauer, MS5, B. Joseph Elmunzer, MD, MSc3
1Indiana University, Indianapolis, IN; 2Digestive Health Associates of Texas, Dallas, TX; 3Medical University of South Carolina, Charleston, SC; 4University of Michigan, Ann Arbor, MI; 5Beth Israel Deaconess Medical Center, Boston, MA; 6University of Wisconsin, Milwaukee, WI; 7Indiana University School of Medicine, Indianapolis, IN; 8Yale University, New Haven, CT; 9Aurora Research Institute, Milwaukee, WI

Award: Category Award (Biliary/Pancreas)

Introduction: Rectal indomethacin (IND) at a dose of 100 mg has been shown to be effective in reducing the frequency and severity of post-ERCP pancreatitis (PEP) in high-risk patients. However, the optimal dose is unknown, and PEP rates still remain high despite its usage. The maximum recommended dose of IND is 200 mg/day, for any indication. Our aim was to compare the efficacy of two dose regimens (100 mg [Group A] vs 200 mg [Group B]) of rectal IND on the frequency and severity of PEP in high-risk patients.

Methods: All eligible patients undergoing ERCP at six participating institutions were recruited. Procedure-related decisions and interventions were dictated by the endoscopist. ”High-risk” was defined by inclusion/exclusion criteria (Tables 1,2). Eligible subjects were randomized to receive either 100mg or 150mg IND, in the form of two or three 50mg rectal suppositories, at the end of the ERCP administered by an unblinded nurse. Group A patients received an additional glycerin suppository. Four hours later, Group B patients received an additional 50mg suppository while in the recovery area, whereas Group A subjects received a glycerin suppository. All participating patients received a total of 4 suppositories, with the endoscopist and clinical research coordinator blinded to allocation. Procedure indications were tallied as were other additional characteristics (Table 3). Complications were defined according to established consensus criteria.

Results: 1037 patients were randomized between July 2013 and March 2018. Overall, PEP occurred in 142 patients (13.7%; mild 8.3%, moderate 4.8%, severe 0.6%), with no significant difference (p>0.05, 100mg vs 200mg) between the two groups in frequency (76/515, 14.8% vs 66/522, 12.6%) or severity (moderate+severe: 28/515, 5.4% vs 28/522, 5.4%) of PEP. Furthermore, there was no difference (p>0.05) between the two groups with respect to incidence of other complications: bleeding (6/515, 1.2% vs 8/522, 1.5%), perforation (4/515, 0.8% vs 4/522, 0.8%), infection (12/515, 2.3% vs 10/522, 1.9%), renal failure (0/515, 0% vs 3/522, 0.6%), cardiac (1/515, 0.2% vs 0/522, 0%) or cerebrovascular events (0/515, 0% vs 1/522, 0.2%).

Discussion: Dose escalation to 200mg of rectal IND does not confer any advantage over the standard 100mg regimen. PEP rates continue to remain high in high-risk patients despite rectal IND. Additional interventions are necessary to further reduce the risk of PEP.

Table 1: Inclusion Criteria
Table 2: Exclusion Criteria
Table 3: Additional Patient/Procedure Characteristics

Disclosures:
Evan Fogel indicated no relevant financial relationships.
Glen Lehman indicated no relevant financial relationships.
Paul Tarnasky indicated no relevant financial relationships.
Gregory Cote indicated no relevant financial relationships.
Richard Kwon indicated no relevant financial relationships.
James Watkins indicated no relevant financial relationships.
Suzette Schmidt indicated no relevant financial relationships.
Stuart Sherman indicated no relevant financial relationships.
Grace Elta indicated no relevant financial relationships.
Jeffrey Easler indicated no relevant financial relationships.
Douglas Pleskow indicated no relevant financial relationships.
Ihab El Hajj indicated no relevant financial relationships.
Akbar Waljee indicated no relevant financial relationships.
Nalini Guda indicated no relevant financial relationships.
Mark Gromski indicated no relevant financial relationships.
Seena Arol indicated no relevant financial relationships.
Sheryl Korsnes indicated no relevant financial relationships.
Lee McHenry indicated no relevant financial relationships.
Alejandro Suarez indicated no relevant financial relationships.
Rebecca Spitzer indicated no relevant financial relationships.
Marilyn MIller indicated no relevant financial relationships.
Maria Hofbauer indicated no relevant financial relationships.
B. Joseph Elmunzer indicated no relevant financial relationships.

Evan L. Fogel

Professor of Medicine
Indiana University Hospital
Indianapolis, Indiana

Dr. Fogel is currently a Professor of Medicine in the Indiana University School of Medicine. Originally from Toronto, Ontario, Canada, he obtained his Masters of Science degree in Pharmacology from the University of Toronto, followed by medical school, Internal Medicine residency and Gastroenterology fellowship at the same institution. Dr. Fogel did a third-tier fellowship in Therapeutic ERCP in 1996-1997 at Indiana University, and joined the GI faculty at IU the following year. He served as Director of the ERCP Fellowship program at IU from 2002-2017. His patient care special interests include endoscopic management of idiopathic pancreatitis, biliary pancreatitis, sphincter of Oddi dysfunction, and prevention of post-ERCP pancreatitis. He is privileged to serve as Principal Investigator of the Indiana University clinical center for the NIDDK/NCI's consortium for the study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC). The CPDPC was formed to undertake a comprehensive clinical, epidemiological, and biological characterization of patients with Chronic Pancreatitis (including those with Acute Recurrent Pancreatitis, ARP) to gain insight into the pathophysiology of chronic pancreatitis and its sequela: chronic pain, pancreatic insufficiency, T3cDM and the diabetes/pancreatic cancer association. He has presented his findings at numerous national and international meetings. Dr. Fogel is a member of ACG, AGA, and ASGE. In addition, he is on the journal review committees of several leading journals in his field.

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1 - Rectal Indomethacin Dose Escalation for Prevention of Post-ERCP Pancreatitis in High-Risk Patients: Preliminary Report of a Multicenter Randomized Trial (RIDE Trial)



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