Prophylactic endoscopic transpapillary gallbladder stenting at fully covered self-expandable metal stent placement to prevent cholecystitis in malignant distal biliary obstruction: A multicenter prospective single-arm study protocol (PROTECT study)
5 affiliations
- 1Department of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan.
- 2Department of Gastroenterology, Yokohama Rosai Hospital, Yokohama, Japan.
- 3Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.
- 4Department of Gastroenterology, Chigasaki Municipal Hospital, Chigasaki, Japan.
- 5Department of Gastroenterology, National Hospital Organization Yokohama Medical Center, Yokohama, Japan.
Abstract
Background: Malignant distal biliary obstruction (MDBO) is commonly managed with endoscopic retrograde cholangiopancreatography (ERCP)-guided transpapillary stenting. Fully covered self-expandable metal stents (FCSEMSs) provide durable biliary drainage but may increase the risk of acute cholecystitis due to cystic duct obstruction. Prophylactic endoscopic transpapillary gallbladder stenting (ETGBS) at the time of FCSEMS placement has been proposed to reduce the risk of cholecystitis after FCSEMS placement. However, the available evidence is limited. This study aims to explore the potential clinical benefit of attempting prophylactic ETGBS by estimating the incidence of acute cholecystitis after FCSEMS placement and characterizing the technical feasibility and safety of the strategy in patients with MDBO. Methods: This multicenter, prospective, single-arm exploratory study (PROTECT study) will be conducted at four institutions in Japan. In all eligible patients undergoing FCSEMS placement for MDBO, prophylactic ETGBS will be attempted. The primary endpoint is the incidence of acute cholecystitis within 30 days after FCSEMS placement. Secondary endpoints include the technical success rate of ETGBS, procedure-related adverse events, the incidence of acute cholecystitis within 30 days among patients with technically successful ETGBS, and the cumulative incidence of acute cholecystitis from day 31 until the end of follow-up. The target enrollment is 50 patients. The primary endpoint will be summarized as a proportion with a two-sided 90% Wilson score confidence interval. A two-sided 95% Wilson score confidence interval will also be reported as a supplementary analysis, and a supplementary exploratory two-sided one-sample score test will compare the observed proportion with the historical benchmark of 12.1%. Discussion: This study will provide prospective data on the potential clinical utility, technical feasibility, and safety of attempting prophylactic ETGBS and may inform the design of future comparative studies. Trial registration: Japan Registry of Clinical Trials number: jRCT1030250361. Registered on 12 September 2025.
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BibTeX
@article{oda2026prophylactic,
title = {{Prophylactic endoscopic transpapillary gallbladder stenting at fully covered self-expandable metal stent placement to prevent cholecystitis in malignant distal biliary obstruction: A multicenter prospective single-arm study protocol (PROTECT study)}},
author = {Takayuki Oda and Yusuke Kurita and Masato Suzuki and Satoru Shinoda and Takamitsu Sato and Shinichi Nihei and Yu Honda and Takeshi Iizuka and Shin Yagi and Sho Hasegawa and Kensuke Kubota and Masato Yoneda},
journal = {PLOS One},
year = {2026},
month = oct,
doi = {10.1371/journal.pone.0361468},
url = {https://doi.org/10.1371/journal.pone.0361468},
note = {CC BY},
}
RIS
TY - JOUR
TI - Prophylactic endoscopic transpapillary gallbladder stenting at fully covered self-expandable metal stent placement to prevent cholecystitis in malignant distal biliary obstruction: A multicenter prospective single-arm study protocol (PROTECT study)
AU - Takayuki Oda
AU - Yusuke Kurita
AU - Masato Suzuki
AU - Satoru Shinoda
AU - Takamitsu Sato
AU - Shinichi Nihei
AU - Yu Honda
AU - Takeshi Iizuka
AU - Shin Yagi
AU - Sho Hasegawa
AU - Kensuke Kubota
AU - Masato Yoneda
PY - 2026
DA - 2026/10/29
JO - PLOS One
DO - 10.1371/journal.pone.0361468
UR - https://doi.org/10.1371/journal.pone.0361468
AB - Background: Malignant distal biliary obstruction (MDBO) is commonly managed with endoscopic retrograde cholangiopancreatography (ERCP)-guided transpapillary stenting. Fully covered self-expandable metal stents (FCSEMSs) provide durable biliary drainage but may increase the risk of acute cholecystitis due to cystic duct obstruction. Prophylactic endoscopic transpapillary gallbladder stenting (ETGBS) at the time of FCSEMS placement has been proposed to reduce the risk of cholecystitis after FCSEMS placement. However, the available evidence is limited. This study aims to explore the potential clinical benefit of attempting prophylactic ETGBS by estimating the incidence of acute cholecystitis after FCSEMS placement and characterizing the technical feasibility and safety of the strategy in patients with MDBO. Methods: This multicenter, prospective, single-arm exploratory study (PROTECT study) will be conducted at four institutions in Japan. In all eligible patients undergoing FCSEMS placement for MDBO, prophylactic ETGBS will be attempted. The primary endpoint is the incidence of acute cholecystitis within 30 days after FCSEMS placement. Secondary endpoints include the technical success rate of ETGBS, procedure-related adverse events, the incidence of acute cholecystitis within 30 days among patients with technically successful ETGBS, and the cumulative incidence of acute cholecystitis from day 31 until the end of follow-up. The target enrollment is 50 patients. The primary endpoint will be summarized as a proportion with a two-sided 90% Wilson score confidence interval. A two-sided 95% Wilson score confidence interval will also be reported as a supplementary analysis, and a supplementary exploratory two-sided one-sample score test will compare the observed proportion with the historical benchmark of 12.1%. Discussion: This study will provide prospective data on the potential clinical utility, technical feasibility, and safety of attempting prophylactic ETGBS and may inform the design of future comparative studies. Trial registration: Japan Registry of Clinical Trials number: jRCT1030250361. Registered on 12 September 2025.
SN - 1932-6203
ER -