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
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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