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Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04167072

Enrollment

Registered

2019-11-18

Start date

2019-11-01

Completion date

2021-01-31

Last updated

2020-04-22

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

Conditions

Cholecystitis, Acute, Cholecystitis; Gallstone

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

Interventions

PROCEDUREStent removal

This is a procedural intervention in which the stent will be removed via endoscopy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Rate of adverse events related to LAMS	1 year	To compare the rate of LAMS related adverse events in these two groups

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026