NCT04167072

Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Texas Tech University Health Sciences Center, El Paso · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).

Detailed description

The study will include patients with stone related cholecystitis that are not adequate surgical candidates that will be treated with EUS guided cholecystoenterostomy with endoscopic stone extraction. Patients will be randomized to stent removal immediately after gallstones have been removed or to observation for 1 year with the stent in place. Outcomes to be measured include recurrence of stone disease and rate of complications from the procedure in both groups

Conditions

• Cholecystitis, Acute
• Cholecystitis; Gallstone

Interventions

Type	Name	Description
PROCEDURE	Stent removal	This is a procedural intervention in which the stent will be removed via endoscopy.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-01-31
• Completion: 2021-01-31
• First posted: 2019-11-18
• Last updated: 2020-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study