COMPLETED

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV). Primary Outcomes: * Residual gastric volume that precludes adequate endoscopic examination * Residual gastric volume that necessitates premature termination of the endoscopy procedure * Need for endotracheal intubation due to stomach contents. * Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission Secondary Outcomes: * Presence of any solid food * Presence of moderate liquid content * Increased RGV(Residual Gastric Volume) defined as any amount of solid content or \> 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister). * Differences in primary and secondary outcomes between different medications

Official Title

Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Quick Facts

Study Start:2024-07-31
Study Completion:2025-05-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06533527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients using incretin-based therapies at a stable dose for more than 1 month.
  2. * Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.
  1. * Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
  2. * Known history of achalasia
  3. * Surgical or genetically altered foregut anatomy
  4. * Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
  5. * Patients who did not follow the standard NPO (nil per oral) instructions.

Contacts and Locations

Study Locations (Sites)

Cleveland Clinic
Weston, Florida, 33331
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31
Study Completion Date2025-05-20

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2025-05-20

Terms related to this study

Keywords Provided by Researchers

  • incretin
  • wegovy
  • ozempic
  • mounjaro
  • glp1
  • gastroparesis
  • residual gastric volume
  • endoscopy
  • anesthesia

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • Obesity
  • Gastroparesis