Skip to content

Prophylactic endoscopic gallbladder stenting for cholecystitis in patients with malignant distal bile duct obstruction receiving SEMS placement: A Randomized controlled trial

Prophylactic endoscopic gallbladder stenting for cholecystitis in patients with malignant distal bile duct obstruction receiving SEMS placement: A Randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250219001
Enrollment
116
Registered
2025-02-19
Start date
2024-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant distal bile duct obstruction patients receiving self-expandable metal stent placement gallbladder stent malignant distal bile duct obstruction

Interventions

ERCP and perform cystic duct cannulation, followed by placing a 7Fr double pigtail plastic stent. The proximal end of plastic stent positioned in the gallbladder and the distal end in duodenum. Then,
Experimental Procedure/Surgery,Experimental Procedure/Surgery
endoscopic gallbladder stent and self-expandable metal stent placement,self expandable metal stent placement alone

Sponsors

Division of gastroenterology and hepatology, Faculty of medicine, Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older, 2.Diagnosed with malignant distal bile duct obstruction by imaging or histology, 3. Indicated for biliary stenting

Exclusion criteria

Exclusion criteria: 1. History of cholecystectomy, 2. Concomitant cholecystitis at the time of self-expandable metal stent placement, 3. Evidence of tumor invade cystic duct orifice, 4.Previous surgery causing anatomy alteration, 5. pregnancy or lactation, 6. denied participation

Design outcomes

Primary

MeasureTime frame
cholecystitis 30 days after procedure clinical and laboratory

Secondary

MeasureTime frame
cholecystitis 90 days after procedure clinical and laboratory,mortality 30 and 90 days after procedure clinical,technical success rate of endoscopic gallbladder stent after procedure cholangiogram ,proceudre-related adverse events after procedure clinical and imaging

Countries

Thailand

Contacts

Public ContactNuttida Polpanich

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

nuttida5448@gmail.com66868755448

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026