Satoki Shichijo1, Yoji Takeuchi1, Yuichi Shimodate2, Takeshi Yamashina3, Tomoaki Yamasaki4, Takemasa Hayashi5, Kingo Hirasawa6, Shusei Fukunaga7, Shinjiro Yamaguchi8, Satoshi Asai9, Takuji Kawamura10, Norimasa Fukata11, Masashi Yamamoto12, Akira Teramoto13, Yuzuru Kinjo14, Kenshi Matsuno15, Tetsu Kinjo16, Yasushi Sano17, Taro Iwatsubo18, Koji Nagaike19, Mio Matsumoto20, Noriyuki Hoki21, Ichiro Kawamura22, Toshio Shimokawa23, Noriya Uedo1, Hideki Ishikawa24, Kiyohito Tanaka10, Masayuki Kitano25. 1. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. 2. Department of Gastroenterology, Kurashiki Central Hospital, Okayama, Japan. 3. Department of Gastroenterology, Osaka Red Cross Hospital, Osaka, Japan. 4. Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan. 5. Digestive Disease Center, Showa University Northern Yokohama Hospital, Kanagawa, Japan. 6. Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan. 7. Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan. 8. Department of Gastroenterology, Kansai Rosai Hospital, Hyogo, Japan. 9. Department of Gastroenterology, Tane General hospital, Osaka, Japan. 10. Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan. 11. The Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan. 12. Department of Gastroenterology, Toyonaka Municipal Hospital, Osaka, Japan. 13. Department of Gastroenterology, Urasoe General Hospital, Okinawa, Japan. 14. Department of Gastroenterology, Naha City Hospital, Okinawa, Japan. 15. Department of Gastroenterology, Kumamoto University Hospital, Kumamoto, Japan. 16. Department of Gastroenterology, Ryukyu University Hospital, Okinawa, Japan. 17. Gastrointestinal Center, Sano Hospital, Hyogo, Japan. 18. Department of Gastroenterology, Moriguchi Keijinkai Hospital, Osaka, Japan. 19. Department of Gastroenterology, Suita Municipal Hospital, Osaka, Japan. 20. Department of Gastroenterology, Sapporo Medical Center NTT EC, Hokkaido, Japan. 21. Department of Gastroenterology, Bell Land General Hospital, Osaka, Japan. 22. Department of Infectious Diseases, Osaka International Cancer Institute, Osaka, Japan. 23. Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan. 24. Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. 25. Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Abstract
BACKGROUND AND AIMS: This study aimed to evaluate the efficacy of perioperative antibiotics against post-endoscopic submucosal dissection (ESD) coagulation syndrome (PECS) in patients undergoing colorectal ESD. METHODS: A prospective, multicenter, randomized controlled, parallel, superiority trial was conducted at 21 Japanese tertiary institutions. Patients with superficial colorectal lesions ≥20 mm and those undergoing ESD management for a single lesion were eligible. Patients with perforation during and after ESD were withdrawn. Before the ESD procedure, participants were randomly assigned (1:1) to either undergo conventional treatment (nonantibiotic group) or investigational treatment (antibiotic group). In the antibiotic group, 3 g of ampicillin-sulbactam was administered just before, 8 hours after, and the morning after ESD. The primary endpoint was the incidence of PECS. The onset of PECS was defined as localized abdominal pain (both spontaneous pain and tenderness) and fever (≥37.6°C) or inflammatory response (leukocytosis [≥10,000 cells/μL] or elevated C-reactive protein level [≥.5 mg/dL]). RESULTS: From February 5, 2019 to September 7, 2020, 432 patients were enrolled and assigned to the antibiotic group (n = 216) or nonantibiotic group (n = 216). After withdrawal of 52 patients, 192 in the antibiotic group and 188 in the nonantibiotic group were analyzed. PECS occurred in 9 of 192 patients (4.7%) in the antibiotic group and 14 of 188 patients (7.5%) in the nonantibiotic group, with an odds ratio of .61 (95% confidence interval, .23-1.56; P = .29). CONCLUSIONS: Perioperative use of antibiotics was not effective in reducing the incidence of PECS in patients undergoing colorectal ESD. (Clinical trial registration number: UMIN000035178.).
BACKGROUND AND AIMS: This study aimed to evaluate the efficacy of perioperative antibiotics against post-endoscopic submucosal dissection (ESD) coagulation syndrome (PECS) in patients undergoing colorectal ESD. METHODS: A prospective, multicenter, randomized controlled, parallel, superiority trial was conducted at 21 Japanese tertiary institutions. Patients with superficial colorectal lesions ≥20 mm and those undergoing ESD management for a single lesion were eligible. Patients with perforation during and after ESD were withdrawn. Before the ESD procedure, participants were randomly assigned (1:1) to either undergo conventional treatment (nonantibiotic group) or investigational treatment (antibiotic group). In the antibiotic group, 3 g of ampicillin-sulbactam was administered just before, 8 hours after, and the morning after ESD. The primary endpoint was the incidence of PECS. The onset of PECS was defined as localized abdominal pain (both spontaneous pain and tenderness) and fever (≥37.6°C) or inflammatory response (leukocytosis [≥10,000 cells/μL] or elevated C-reactive protein level [≥.5 mg/dL]). RESULTS: From February 5, 2019 to September 7, 2020, 432 patients were enrolled and assigned to the antibiotic group (n = 216) or nonantibiotic group (n = 216). After withdrawal of 52 patients, 192 in the antibiotic group and 188 in the nonantibiotic group were analyzed. PECS occurred in 9 of 192 patients (4.7%) in the antibiotic group and 14 of 188 patients (7.5%) in the nonantibiotic group, with an odds ratio of .61 (95% confidence interval, .23-1.56; P = .29). CONCLUSIONS: Perioperative use of antibiotics was not effective in reducing the incidence of PECS in patients undergoing colorectal ESD. (Clinical trial registration number: UMIN000035178.).