Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Texas Tech University Health Sciences Center, El Paso

Status: Withdrawn

Conditions: Cholecystitis; Gallstone; Cholecystitis, Acute

Treatments: Procedure: Stent removal

Study type: Interventional

Funder types: Other

Identifiers

NCT04167072

E20025

Details and patient eligibility

About

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).

Full 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

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Scheduled removal

Experimental group

Description:

This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder

Treatment:

Procedure: Stent removal

Observation

Active Comparator group

Description:

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.

Treatment:

Procedure: Stent removal