TY - JOUR
T1 - Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy
T2 - A Randomized Controlled Trial
AU - Kato, Shin
AU - Kuwatani, Masaki
AU - Onodera, Manabu
AU - Kudo, Taiki
AU - Sano, Itsuki
AU - Katanuma, Akio
AU - Uebayashi, Minoru
AU - Eto, Kazunori
AU - Fukasawa, Mitsuharu
AU - Hashigo, Shunpei
AU - Iwashita, Takuji
AU - Yoshida, Makoto
AU - Taya, Yoko
AU - Kawakami, Hiroshi
AU - Kato, Hironari
AU - Nakai, Yousuke
AU - Kobashigawa, Kasen
AU - Kawahata, Shuhei
AU - Shinoura, Susumu
AU - Ito, Kei
AU - Kubo, Kimitoshi
AU - Yamato, Hiroaki
AU - Hara, Kazuo
AU - Maetani, Iruru
AU - Mukai, Tsuyoshi
AU - Shibukawa, Goro
AU - Itoi, Takao
N1 - Funding Information:
Funding This study was supported by a grant from the JFE ( The Japanese Foundation for Research and Promotion of Endoscopy ).
Publisher Copyright:
© 2022 AGA Institute
PY - 2022/6
Y1 - 2022/6
N2 - Background & Aims: The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP. Methods: Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement. Results: PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%–23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups. Conclusion: ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm
AB - Background & Aims: The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP. Methods: Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement. Results: PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%–23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups. Conclusion: ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm
KW - Biliary Drainage
KW - Biliary Stricture
KW - Endoscopic Sphincterotomy
KW - Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis
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U2 - 10.1016/j.cgh.2021.08.016
DO - 10.1016/j.cgh.2021.08.016
M3 - Article
C2 - 34391923
AN - SCOPUS:85118644328
SN - 1542-3565
VL - 20
SP - 1394-1403.e1
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 6
ER -