PMID- 31845139 OWN - NLM STAT- MEDLINE DCOM- 20210414 LR - 20240213 IS - 1873-4626 (Electronic) IS - 1091-255X (Linking) VI - 24 IP - 11 DP - 2020 Nov TI - Effect on Bleeding Prevention of an Intravenous Proton Pump Inhibitor During the Fasting Period After Endoscopic Submucosal Dissection: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. PG - 2596-2601 LID - 10.1007/s11605-019-04466-9 [doi] AB - BACKGROUND: No consensus has been achieved on optimal perioperative strategies for patients undergoing endoscopic submucosal dissection (ESD). The aim of this study was to investigate the effects of an intravenous (IV) proton pump inhibitor (PPI) given during the fasting period after ESD on delayed bleeding following ESD. METHODS: This study was designed as a prospective, randomized, double-blind, placebo-controlled trial in a single center. A total of 235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018 were randomized into a PPI group and placebo group. Patients were administrated intravenous pantoprazole 40 mg daily (PPI group) or placebo (placebo group) during the fasting period 48 h after ESD (from the day of ESD to the following day, 48 h). After oral feeding (48 h after ESD), oral PPI was given to both groups for 8 weeks. RESULTS: Among 235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis, there was no significant difference between the PPI and control groups in major bleeding (PPI vs. placebo; 3.3% vs. 1.7%, p = 0.27) or minor bleeding (PPI vs. placebo; 7.6% vs. 4.3%, p = 0.41) after ESD. There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups. The only independent risk factor for major delayed bleeding was the combined use of aspirin and antiplatelet agent (OR; 12.25, 95% CI; 1.06-141.19, p = 0.04). CONCLUSIONS: Administration of routine IV PPI during the fasting period 48 h after ESD does not reduce delayed post-ESD bleeding. FAU - Yoon, Jai Hoon AU - Yoon JH AD - Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea. FAU - Kim, Youn Jeong AU - Kim YJ AD - Division of Infectious disease, Department of Internal medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea. FAU - Lee, Kang Nyeong AU - Lee KN AD - Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea. FAU - Jun, Dae Won AU - Jun DW AD - Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea. FAU - Koh, Dong Hee AU - Koh DH AD - Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, South Korea. FAU - Lee, Hang Lak AU - Lee HL AD - Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea. alwayshang@hanyang.ac.kr. AD - Department of Gastroenterology, Hanyang University Hospital, Sungdonggu Hangdangdong 17, Seoul, 133-070, South Korea. alwayshang@hanyang.ac.kr. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20191216 PL - Netherlands TA - J Gastrointest Surg JT - Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract JID - 9706084 RN - 0 (Anti-Ulcer Agents) RN - 0 (Proton Pump Inhibitors) SB - IM MH - *Anti-Ulcer Agents/therapeutic use MH - *Endoscopic Mucosal Resection/adverse effects MH - Fasting MH - Gastroscopy MH - Humans MH - Prospective Studies MH - Proton Pump Inhibitors MH - *Stomach Neoplasms/drug therapy/surgery OTO - NOTNLM OT - Bleeding OT - Endoscopic submucosal dissection OT - Proton pump inhibitor EDAT- 2019/12/18 06:00 MHDA- 2021/04/15 06:00 CRDT- 2019/12/18 06:00 PHST- 2019/04/28 00:00 [received] PHST- 2019/11/06 00:00 [accepted] PHST- 2019/12/18 06:00 [pubmed] PHST- 2021/04/15 06:00 [medline] PHST- 2019/12/18 06:00 [entrez] AID - S1091-255X(23)01846-2 [pii] AID - 10.1007/s11605-019-04466-9 [doi] PST - ppublish SO - J Gastrointest Surg. 2020 Nov;24(11):2596-2601. doi: 10.1007/s11605-019-04466-9. Epub 2019 Dec 16.