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Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04167072
Recruitment Status : Withdrawn (Unexpected difficulties recruiting and following patients)
First Posted : November 18, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Mendoza-Ladd, 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).

Condition or disease Intervention/treatment Phase
Cholecystitis, Acute Cholecystitis; Gallstone Procedure: Stent removal Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Scheduled removal
This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
Procedure: Stent removal
This is a procedural intervention in which the stent will be removed via endoscopy.

Active Comparator: Observation
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.
Procedure: Stent removal
This is a procedural intervention in which the stent will be removed via endoscopy.




Primary Outcome Measures :
  1. Recurrence of GB findings [ Time Frame: 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 :
  1. Rate of adverse events related to LAMS [ Time Frame: 1 year ]
    To compare the rate of LAMS related adverse events in these two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04167072


Locations
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United States, Texas
University Medical Center of El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
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Responsible Party: Antonio Mendoza-Ladd, Assistant Professor of Medicine/Director of Endoscopy, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT04167072    
Other Study ID Numbers: E20025
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Gallstones
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis
Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical