Hui Luo1, Xiangping Wang1, Rongchun Zhang1, Shuhui Liang1, Xiaoyu Kang1, Xiaofeng Zhang2, Qifeng Lou2, Kangwei Xiong2, Jing Yang2, Lijuan Si3, Wenming Liu3, Yunpeng Liu3, Yi Zhou4, Suli Wang4, Mei Yang4, Wei Chen5, Yanzhi Han5, Guochen Shang5, Xiaocui Yang6, Yongfeng He6, Qiang Zou6, Wenwei Guo6, Yichen Dai7, Wei Zeng7, Xiaosan Zhu7, Rongqing Gong7, Xun Li8, Zhanguo Nie9, Qi Wang10, Ling Wang11, Yanglin Pan12, Xuegang Guo13, Daiming Fan1. 1. State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. 2. Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China. 3. Department of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China. 4. Department of Gastroenterology, No 451 Military Hospital, Xi'an, China. 5. Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University, Shihezi, China. 6. Endoscopy Center, Ankang Central Hospital, Ankang, China. 7. Department of Gastroenterology, Chenggong Hospital of Xiamen University, Xiamen, China. 8. The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China. 9. Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China. 10. Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China. 11. Department of Health Statistics, Fourth Military Medical University, Xi'an, Shaanxi, China. 12. State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. Electronic address: yanglinpan@hotmail.com. 13. State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China. Electronic address: xuegangguo@gmail.com.
Abstract
BACKGROUND & AIMS:Rectal indomethacin and spraying of the duodenal papilla with epinephrine might reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We performed a randomized trial to compare the effects of the combination of indomethacin and epinephrine (IE) vs indomethacin plus saline (IS) in prophylaxis of post-ERCP pancreatitis (PEP). METHODS: We performed a double-blind trial at 10 centers in China, from February 2017 to October 2017, of 1158 patients with native papilla undergoing ERCP. The patients were assigned randomly to groups given IE (n = 576) or IS (n = 582). All patients received a single dose of rectal indomethacin within 30 minutes before ERCP; 20 mL of dilute epinephrine (IE group) or saline (IS group) then was sprayed on the duodenal papilla at the end of ERCP. The primary outcome was the incidence of overall PEP. Data were analyzed on an intention-to-treat principle. RESULTS: The study was terminated at the interim analysis for safety concerns and futility. The groups had similar baseline characteristics. PEP developed in 49 patients in the IE group (8.5%) and in 31 patients in the IS group (5.3%) (relative risk, 1.60, 95% CI, 1.03-2.47; P = .033). There were no significant differences between groups in proportions of patients with postsphincterotomy bleeding (2.1% in the IE group and 1.5% in the IS group) and biliary infection (1.2% in the IE group and 2.2% in the IS group). CONCLUSIONS: In a randomized trial, we found the combination of rectal indomethacin with papillary epinephrine spraying increased the risk of PEP compared with indomethacin alone. Spray epinephrine should not be used with rectal indomethacin for prevention of post-ERCP pancreatitis. ClincialTrials.gov no: NCT03057769.
RCT Entities:
BACKGROUND & AIMS: Rectal indomethacin and spraying of the duodenal papilla with epinephrine might reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We performed a randomized trial to compare the effects of the combination of indomethacin and epinephrine (IE) vs indomethacin plus saline (IS) in prophylaxis of post-ERCP pancreatitis (PEP). METHODS: We performed a double-blind trial at 10 centers in China, from February 2017 to October 2017, of 1158 patients with native papilla undergoing ERCP. The patients were assigned randomly to groups given IE (n = 576) or IS (n = 582). All patients received a single dose of rectal indomethacin within 30 minutes before ERCP; 20 mL of dilute epinephrine (IE group) or saline (IS group) then was sprayed on the duodenal papilla at the end of ERCP. The primary outcome was the incidence of overall PEP. Data were analyzed on an intention-to-treat principle. RESULTS: The study was terminated at the interim analysis for safety concerns and futility. The groups had similar baseline characteristics. PEP developed in 49 patients in the IE group (8.5%) and in 31 patients in the IS group (5.3%) (relative risk, 1.60, 95% CI, 1.03-2.47; P = .033). There were no significant differences between groups in proportions of patients with postsphincterotomy bleeding (2.1% in the IE group and 1.5% in the IS group) and biliary infection (1.2% in the IE group and 2.2% in the IS group). CONCLUSIONS: In a randomized trial, we found the combination of rectal indomethacin with papillary epinephrine spraying increased the risk of PEP compared with indomethacin alone. Spray epinephrine should not be used with rectal indomethacin for prevention of post-ERCP pancreatitis. ClincialTrials.gov no: NCT03057769.
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
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Authors: Adriana Fabiola Romano-Munive; J Jesus García-Correa; Luis F García-Contreras; José Ramírez-García; Luis Uscanga; Varenka J Barbero-Becerra; Carlos Moctezuma-Velázquez; Jorge A Ochoa-Rubí; Julio Toledo-Cuque; Gerardo Vázquez-Anaya; Daniel Keil-Ríos; Guido Grajales-Figueroa; Miguel Ángel Ramírez-Luna; Francisco Valdovinos-Andraca; Luis Eduardo Zamora-Nava; Felix Tellez-Avila Journal: BMJ Open Gastroenterol Date: 2021-02