Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial.

Cholangiopancreatography, Endoscopic Retrograde / adverse effects Cholestasis / etiology Constriction, Pathologic / etiology Humans Pancreatitis / epidemiology Sphincterotomy, Endoscopic / adverse effects Stents / adverse effects
Biliary Drainage Biliary Stricture Endoscopic Sphincterotomy Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
06 2022
Historique:
received: 19 03 2021
revised: 04 08 2021
accepted: 04 08 2021
pubmed: 16 8 2021
medline: 10 5 2022
entrez: 15 8 2021
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1016/j.cgh.2021.08.016 PMID: 34391923
pubmed: 34391923
pii: S1542-3565(21)00872-7
doi: 10.1016/j.cgh.2021.08.016
pii:
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1394-1403.e1

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.

Auteurs

Shin Kato (S)

Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.

Masaki Kuwatani (M)

Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan; Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan. Electronic address: mkuwatan@med.hokudai.ac.jp.

Manabu Onodera (M)

Department of Gastroenterology, NTT Medical Center Sapporo Hospital, Sapporo, Japan.

Taiki Kudo (T)

Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan.

Itsuki Sano (I)

Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan.

Akio Katanuma (A)

Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.

Minoru Uebayashi (M)

Department of Gastroenterology, Kitami Red Cross Hospital, Kitami, Japan.

Kazunori Eto (K)

Department of Gastroenterology, Tomakomai Municipal Hospital, Tomakomai, Japan.

Mitsuharu Fukasawa (M)

First Department of Internal Medicine, University of Yamanashi, Chuo, Japan.

Shunpei Hashigo (S)

Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.

Takuji Iwashita (T)

First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.

Makoto Yoshida (M)

Department of Medical Oncology, Sapporo Medical University Hospital, Sapporo, Japan.

Yoko Taya (Y)

Department of Gastroenterology, NHO Hokkaido Medical Center, Sapporo, Japan.

Hiroshi Kawakami (H)

Department of Gastroenterology, University of Miyazaki Hospital, Miyazaki, Japan.

Hironari Kato (H)

Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan.

Yousuke Nakai (Y)

Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital, Tokyo, Japan; Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.

Kasen Kobashigawa (K)

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Gastroenterology, Urasoe General Hospital, Urasoe, Japan.

Shuhei Kawahata (S)

Department of Gastroenterology, Obihiro-Kosei General Hospital, Obihiro, Japan.

Susumu Shinoura (S)

Department of Gastroenterology, Okinawa Prefectural Chubu Hospital, Uruma, Japan.

Kei Ito (K)

Department of Gastroenterology, Sendai Open Hospital, Sendai, Japan.

Kimitoshi Kubo (K)

Department of Gastroenterology, NHO Hakodate Hospital, Hakodate, Japan.

Hiroaki Yamato (H)

Department of Gastroenterology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan.

Kazuo Hara (K)

Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.

Iruru Maetani (I)

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.

Tsuyoshi Mukai (T)

Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.

Goro Shibukawa (G)

Department of Gastroenterology, Fukushima Medical University, Aizu Medical Center, Aizu, Japan.

Takao Itoi (T)

Department of Gastroenterology, Tokyo Medical University Hospital, Tokyo, Japan.

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Classifications MeSH

questionsmedicales.fr › Procédures de chirurgie opératoire › Interventions chirurgicales mini-invasives › Endoscopie › Endoscopie digestive › Cholangiopancréatographie rétrograde endoscopique › Risk of Pancreatitis Following Biliary...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladie des voies biliaires › Maladies des canaux biliaires › Cholestase › Risk of Pancreatitis Following Biliary...
questionsmedicales.fr › États, signes et symptômes pathologiques › États anatomopathologiques › Sténose pathologique › Risk of Pancreatitis Following Biliary...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Risk of Pancreatitis Following Biliary...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies du pancréas › Pancréatite › Risk of Pancreatitis Following Biliary...
questionsmedicales.fr › Procédures de chirurgie opératoire › Myotomie › Sphinctérotomie › Sphinctérotomie endoscopique › Risk of Pancreatitis Following Biliary...
questionsmedicales.fr › Équipement et fournitures › Prothèses et implants › Endoprothèses › Risk of Pancreatitis Following Biliary...