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Transgastrostomal Endoscopies

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: NCT04309825
Recruitment Status : Withdrawn (no IRB approval)
First Posted : March 16, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
Upper GI endoscopies are commonly done by inserting the endoscope through the patient's mouth. When a patient has a gastrostomy feeding tube, the endoscope can be inserted through the stomach port opening. The aim is to prove this modification would lead to various health benefits, including need for lighter anesthesia, rapid recovery time and fewer anesthesia related adverse reactions.

Condition or disease Intervention/treatment Phase
Esophagogastroduodenoscopies Procedure: transgastrostomal endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: To examine the efficacy of transgastrostomal endoscopies among a single group of patients with a gastrostomy feeding tube
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Efficacy of Transgastrostomal Esophagogastroduodenoscopies in Children
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: G-tube endoscopies patients
patients who will undergo an endoscopy through g-tube port
Procedure: transgastrostomal endoscopy
Placement the endoscope through the g-tube port and not through the mouth of a patient undergoing an upper gi endoscopy




Primary Outcome Measures :
  1. Obtain adequate biopsies [ Time Frame: 15 minutes ]
    Conduct a full endoscopy via g-tube port. Advance the scope to all standard locations including proximal esophagus, distal esophagus, stomach, duodenal bulb and the second part of the duodenum. Obtain at least 2 specimens from each location.


Secondary Outcome Measures :
  1. anesthesia related adverse reactions [ Time Frame: 15 minutes ]
    Assess the rate of anesthesia related adverse reactions. Specifically, record the number of oxygen desaturations during the endoscopy (vital signs are continuously recorded during the exam). After the procedure the anesthesia team will summarize any anesthesia adverse reactions that have occurred during the exam.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- children with a percutaneous gastrostomy feeding tube, who are about to have a diagnostic esophagogastroduodenoscopy.

Exclusion Criteria:

  • age>18 years,
  • G-tube size <12Fr.
  • Patients with immature gastrocutaneous fistula (< 4 weeks after gastrostomy)

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): NCT04309825


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04309825    
Other Study ID Numbers: 2000027348
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 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: No