Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Not Applicable

Withdrawn

• Conditions: Cholecystitis, Acute; Cholecystitis; Gallstone
• Interventions: Procedure: Stent removal

• Registration Number: NCT04167072
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief 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

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Ages 18-100 years or age
2. Both genders
3. Diagnosis of acute cholecystitis by TG13 criteria.
4. Patients who are able to give consent
5. Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team.

Exclusion Criteria

1. Unable to provide informed consent
2. Cardiorespiratory dysfunction that precludes sedation
3. Pregnant females
4. Presence of ascites (distance between duodenum and GB > 1 cm) and/or coagulopathy (INR > 3, PLT <20K)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scheduled removal	Stent removal	This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
Observation	Stent removal	This group involves patients who will be followed closely for 1 year after all the stones have been removed from the gallbladder. These patients will keep the stent in place for 1 year and at that time the patients will be offered removal of the stent.

Primary Outcome Measures

Name	Time	Method
Recurrence of GB findings	1 year	To compare the recurrence of GB findings in patients undergoing EUS guided GB drainage with a lumen-apposing metal stent(LAMS) assigned to scheduled stent removal vs those assigned to long-term observation only.

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events related to LAMS	1 year	To compare the rate of LAMS related adverse events in these two groups

Trial Locations

Locations (1)

University Medical Center of El Paso; 🇺🇸 El Paso, Texas, United States