Trial Outcomes & Findings for Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy (NCT NCT06533527)
NCT ID: NCT06533527
Last Updated: 2025-12-05
Results Overview
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
Procedure
Results posted on
2025-12-05
Participant Flow
Adults 18 or older who were scheduled to undergo an upper endoscopic procedure under monitored anesthesia care or moderate sedation were recruited from Cleveland Clinic hospital main campus or Cleveland Clinic Weston. Patients undergoing colonoscopy were permitted to participate if they were also undergoing an upper endoscopic procedure concurrently. Recruitment occurred from July 2024 until May 2025.
One patient was excluded prior to assignment due to having stop the GLP medication prior to randomization.
Participant milestones
| Measure |
Continue medication as normal prior to endoscopic procedure
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
|
Hold dose prior to endoscopic procedure
Withholds prior dose of incretin therapy per ASA guidance recommendations.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
32
|
|
Overall Study
COMPLETED
|
28
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Continue Medication as Normal Prior to Endoscopic Procedure
n=28 Participants
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
|
Hold Dose Prior to Endoscopic Procedure
n=32 Participants
Withholds prior dose of incretin therapy per ASA guidance recommendations.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=28 Participants
|
62.5 years
n=32 Participants
|
62.5 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=28 Participants
|
15 Participants
n=32 Participants
|
30 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=28 Participants
|
17 Participants
n=32 Participants
|
30 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Diabetes
|
7 Participants
n=28 Participants • Number of patients with diagnosed with Diabetes Mellitus
|
10 Participants
n=32 Participants • Number of patients with diagnosed with Diabetes Mellitus
|
17 Participants
n=60 Participants • Number of patients with diagnosed with Diabetes Mellitus
|
|
A1c greater than 7
|
7 Participants
n=28 Participants
|
6 Participants
n=32 Participants
|
13 Participants
n=60 Participants
|
|
A1c
|
6.4 Percent of glycated hemoglobin
n=28 Participants
|
6.4 Percent of glycated hemoglobin
n=32 Participants
|
6.4 Percent of glycated hemoglobin
n=60 Participants
|
|
BMI
|
31.0 kg/m^2
n=28 Participants
|
29.7 kg/m^2
n=32 Participants
|
30 kg/m^2
n=60 Participants
|
|
Drug type
Dulaglutide
|
3 Participants
n=28 Participants
|
4 Participants
n=32 Participants
|
7 Participants
n=60 Participants
|
|
Drug type
Semaglutide
|
10 Participants
n=28 Participants
|
20 Participants
n=32 Participants
|
30 Participants
n=60 Participants
|
|
Drug type
Tirzepatide
|
15 Participants
n=28 Participants
|
8 Participants
n=32 Participants
|
23 Participants
n=60 Participants
|
|
Duration on drug
|
6.0 months
n=28 Participants
|
5.5 months
n=32 Participants
|
5.8 months
n=60 Participants
|
|
Indications for the Procedure
Heartburn
|
3 Participants
n=28 Participants
|
5 Participants
n=32 Participants
|
8 Participants
n=60 Participants
|
|
Indications for the Procedure
Dyspepsia
|
3 Participants
n=28 Participants
|
2 Participants
n=32 Participants
|
5 Participants
n=60 Participants
|
|
Indications for the Procedure
Anemia
|
1 Participants
n=28 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=60 Participants
|
|
Indications for the Procedure
Disease follow-up
|
8 Participants
n=28 Participants
|
12 Participants
n=32 Participants
|
20 Participants
n=60 Participants
|
|
Indications for the Procedure
Others
|
10 Participants
n=28 Participants
|
13 Participants
n=32 Participants
|
23 Participants
n=60 Participants
|
|
Preprocedural symptoms
Nausea
|
1 Participants
n=28 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=60 Participants
|
|
Preprocedural symptoms
Vomiting
|
1 Participants
n=28 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=60 Participants
|
|
Preprocedural symptoms
Heartburn
|
1 Participants
n=28 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=60 Participants
|
|
Preprocedural symptoms
Dyspepsia
|
1 Participants
n=28 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=60 Participants
|
|
Preprocedural symptoms
Bloating
|
2 Participants
n=28 Participants
|
1 Participants
n=32 Participants
|
3 Participants
n=60 Participants
|
|
Preprocedural symptoms
Other Symptoms
|
9 Participants
n=28 Participants
|
12 Participants
n=32 Participants
|
21 Participants
n=60 Participants
|
|
Preprocedural symptoms
No symptoms reported
|
13 Participants
n=28 Participants
|
18 Participants
n=32 Participants
|
31 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: ProcedureResidual gastric volume (RGV) that precludes adequate endoscopic examination
Outcome measures
| Measure |
Continue medication as normal prior to endoscopic procedure
n=28 Participants
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
|
Hold dose prior to endoscopic procedure
n=32 Participants
Withholds prior dose of incretin therapy per ASA guidance recommendations.
|
|---|---|---|
|
Presence of RGV (Residual Gastric Volume) in Stomach
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: ProcedureOutcome measures
| Measure |
Continue medication as normal prior to endoscopic procedure
n=28 Participants
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
|
Hold dose prior to endoscopic procedure
n=32 Participants
Withholds prior dose of incretin therapy per ASA guidance recommendations.
|
|---|---|---|
|
Tracking the Use of Intubation Due to RGV
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: ProcedureOccurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Outcome measures
| Measure |
Continue medication as normal prior to endoscopic procedure
n=28 Participants
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
|
Hold dose prior to endoscopic procedure
n=32 Participants
Withholds prior dose of incretin therapy per ASA guidance recommendations.
|
|---|---|---|
|
Aspiration Events Due to RGV (Residual Gastric Volume)
|
0 number of aspiration events
|
0 number of aspiration events
|
Adverse Events
Continue medication as normal prior to endoscopic procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hold dose prior to endoscopic procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tilak Shah
Cleveland Clinic Florida (Weston Hospital)
Phone: 954-659-5646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place