Takeshi Tomoda1, Hironari Kato2, Toru Ueki3, Yutaka Akimoto4, Hidenori Hata5, Masakuni Fujii6, Ryo Harada7, Tsuneyoshi Ogawa8, Masaki Wato9, Masahiro Takatani10, Minoru Matsubara11, Yoshinari Kawai12, Hiroyuki Okada2. 1. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. Electronic address: tomotake79@yahoo.co.jp. 2. Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. 3. Department of Internal Medicine, Fukuyama City Hospital, Fukuyama, Japan. 4. Department of Gastroenterology, Iwakuni Clinical Center, Iwakuni, Japan. 5. Department of Gastroenterology, Mitoyo General Hospital, Kanonji, Japan. 6. Department of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, Japan. 7. Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Japan. 8. Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan. 9. Department of Gastroenterology, Kagawa Prefectural Central Hospital, Takamatsu, Japan. 10. Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan. 11. Department of Internal Medicine, Sumitomo Besshi Hospital, Niihama, Japan. 12. Department of Gastroenterology, Onomichi Municipal Hospital, Onomichi, Japan.
Abstract
BACKGROUND & AIMS: Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). Little is known about the combined effects of sublingual nitrate and NSAIDs. We performed a randomized trial to assess whether the combination of NSAIDs and sublingual nitrate is more effective than NSAIDs alone in preventing PEP. METHODS: In a prospective superiority trial, eligible patients underwent ERCP at 12 endoscopic units in Japan, from March 2015 through May 2018. Patients were randomly assigned to groups given diclofenac suppositories (50 mg) within 15 minutes after the endoscopic procedure alone (diclofenac-alone group, n = 442) or in combination with sublingual isosorbide dinitrate (5 mg) 5 minutes before the endoscopic procedure (combination group, n = 444). The primary endpoint was the occurrence of PEP. RESULTS:PEP developed in 25 patients in the combination group (5.6%), and in 42 patients in the diclofenac-alone group (9.5%) (relative risk 0.59; 95% confidence interval 0.37-0.95; P = .03). Moderate to severe pancreatitis developed in 4 patients (0.9%) in the combination group, and 10 patients (2.3%) in the diclofenac-alone group (relative risk 0.12; 95% confidence interval 0.13-1.26; P = .12). There was no serious adverse event related to the additional administration of sublingual nitrate. CONCLUSIONS: In a randomized controlled trial, we found that prophylaxis with rectal diclofenac and sublingual nitrate significantly reduces the overall incidence of PEP compared with diclofenac suppository alone. ClinicalTrials.gov, no: UMIN 000016274.
RCT Entities:
BACKGROUND & AIMS: Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). Little is known about the combined effects of sublingual nitrate and NSAIDs. We performed a randomized trial to assess whether the combination of NSAIDs and sublingual nitrate is more effective than NSAIDs alone in preventing PEP. METHODS: In a prospective superiority trial, eligible patients underwent ERCP at 12 endoscopic units in Japan, from March 2015 through May 2018. Patients were randomly assigned to groups given diclofenac suppositories (50 mg) within 15 minutes after the endoscopic procedure alone (diclofenac-alone group, n = 442) or in combination with sublingual isosorbide dinitrate (5 mg) 5 minutes before the endoscopic procedure (combination group, n = 444). The primary endpoint was the occurrence of PEP. RESULTS: PEP developed in 25 patients in the combination group (5.6%), and in 42 patients in the diclofenac-alone group (9.5%) (relative risk 0.59; 95% confidence interval 0.37-0.95; P = .03). Moderate to severe pancreatitis developed in 4 patients (0.9%) in the combination group, and 10 patients (2.3%) in the diclofenac-alone group (relative risk 0.12; 95% confidence interval 0.13-1.26; P = .12). There was no serious adverse event related to the additional administration of sublingual nitrate. CONCLUSIONS: In a randomized controlled trial, we found that prophylaxis with rectal diclofenac and sublingual nitrate significantly reduces the overall incidence of PEP compared with diclofenac suppository alone. ClinicalTrials.gov, no: UMIN 000016274.
Authors: Christoph F Dietrich; Noor L Bekkali; Sean Burmeister; Yi Dong; Simon M Everett; Michael Hocke; Andre Ignee; Wei On; Srisha Hebbar; Kofi Oppong; Siyu Sun; Christian Jenssen; Barbara Braden Journal: Endosc Ultrasound Date: 2022 May-Jun Impact factor: 5.275
Authors: Adham E Obeidat; Ratib Mahfouz; Gabriel Monti; Landon Kozai; Mohammad Darweesh; Mahmoud M Mansour; Ahmad Alqam; David Hernandez Journal: Cureus Date: 2022-01-31