Rectal Indomethacin and Spraying of Duodenal Papilla With Epinephrine Increases Risk of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography
Autor: | Qifeng Lou, Yi Zhou, Yanzhi Han, Rongchun Zhang, Yanglin Pan, Suli Wang, Guochen Shang, Xiangping Wang, Daiming Fan, Yongfeng He, Wenming Liu, Ling Wang, Qi Wang, Xun Li, Mei Yang, Wenwei Guo, Lijuan Si, Xiao-San Zhu, Wei Zeng, Zhanguo Nie, Xuegang Guo, Shuhui Liang, Xiaofeng Zhang, Xiaocui Yang, Qiang Zou, Kangwei Xiong, Rongqing Gong, Jing Yang, Hui Luo, Yunpeng Liu, Xiaoyu Kang, Wei Chen, Yi-Chen Dai |
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Rok vydání: | 2019 |
Předmět: |
Male
medicine.medical_treatment Indomethacin Gastroenterology law.invention 0302 clinical medicine Randomized controlled trial Risk Factors law Saline Aged 80 and over Cholangiopancreatography Endoscopic Retrograde Endoscopic retrograde cholangiopancreatography medicine.diagnostic_test Incidence Middle Aged Epinephrine 030220 oncology & carcinogenesis Chemoprophylaxis Drug Therapy Combination Female 030211 gastroenterology & hepatology medicine.drug Adult Ampulla of Vater China medicine.medical_specialty Adolescent Risk Assessment Article Young Adult 03 medical and health sciences Double-Blind Method Administration Rectal Internal medicine medicine Humans Therapeutic Irrigation Aged Retrospective Studies Hepatology business.industry medicine.disease Interim analysis Major duodenal papilla Pancreatitis business Follow-Up Studies |
Zdroj: | Clinical Gastroenterology and Hepatology. 17:1597-1606.e5 |
ISSN: | 1542-3565 |
Popis: | 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. |
Databáze: | OpenAIRE |
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