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Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Primary Purpose

Cholecystitis, Acute, Cholecystitis; Gallstone

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stent removal

About this trial

This is an interventional treatment trial for Cholecystitis, Acute

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University Medical Center of El Paso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scheduled removal

Observation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Recurrence of GB findings

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

Rate of adverse events related to LAMS

To compare the rate of LAMS related adverse events in these two groups

Full Information

NCT ID

NCT04167072

First Posted

November 14, 2019

Last Updated

April 20, 2020

Sponsor

Texas Tech University Health Sciences Center, El Paso

1. Study Identification

Unique Protocol Identification Number

NCT04167072

Brief Title

Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Unexpected difficulties recruiting and following patients

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

January 31, 2021 (Anticipated)

Study Completion Date

January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Tech University Health Sciences Center, El Paso

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystitis, Acute, Cholecystitis; Gallstone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scheduled removal

Arm Type

Experimental

Arm Description

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

Arm Title

Observation

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Stent removal

Intervention Description

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

Primary Outcome Measure Information:

Title

Recurrence of GB findings

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Rate of adverse events related to LAMS

Description

To compare the rate of LAMS related adverse events in these two groups

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-100 years or age Both genders Diagnosis of acute cholecystitis by TG13 criteria. Patients who are able to give consent Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team. Exclusion Criteria: Unable to provide informed consent Cardiorespiratory dysfunction that precludes sedation Pregnant females Presence of ascites (distance between duodenum and GB > 1 cm) and/or coagulopathy (INR > 3, PLT <20K)

Facility Information:

Facility Name

University Medical Center of El Paso

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

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