Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

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Cholecystitis
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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.

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 Type

Interventional

Primary Outcome

Recurrence of GB findings

Secondary Outcome

 Rate of adverse events related to LAMS

Condition

Cholecystitis, Acute

Intervention

Stent removal

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

November 1, 2019

Completion Date

January 31, 2021

Primary Completion Date

January 31, 2021

Eligibility Criteria

        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)

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04167072

Organization ID

E20025

Responsible Party

Principal Investigator

Study Sponsor

Texas Tech University Health Sciences Center, El Paso

Study Sponsor

, ,

Verification Date

April 2020