Phase 2
N=110
Metoclopramide Versus Placebo for GJ Placement
Radiation Exposure · Enteral Nutrition
Bottom Line
View on ClinicalTrials.gov: NCT03331965 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Time to Duodenal Intubation — 1.6; 4.1 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metoclopramide 5 MG/ML Injectable Solution (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Duodenal Intubation |
1.6; 4.1 | — |
| SECONDARY Total Procedure Fluoroscopy Time |
5.8; 8.8 | — |
| SECONDARY Total Procedure Air Kerma |
91; 130 | — |
| SECONDARY Total Procedure Time |
16.4; 19.9 | — |
Summary
The goal of this study is to determine whether use of promotility agents to stimulate gastric peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ) tubes placement in interventional radiology (IR). The investigators hypothesize that increased gastric peristalsis will aid in advancing a guidewire through the pylorus, a time consuming and tedious step required during GJ tube placement. In order to maximize scientific rigor and clinical practice impact, the investigators aim to answer this question through a blinded, randomized, placebo controlled trial.
Specific Aim 1: To test the hypothesis that a single dose of IV metoclopramide immediately prior to GJ tube placement reduces the fluoroscopy time required to advance a guidewire through the pylorus.
Specific Aim 2: To determine whether a single dose of IV metoclopramide immediately prior to GJ tube placement reduces total procedure fluoroscopy time, air kerma and total procedure time.
Specific Aim 3: To assess the safety of a single dose of promotility agent prior to GJ tube placement by assessing rates of adverse events in the periprocedural period in patients receiving IV metoclopramide versus placebo.
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- undergoing de novo GJ placement as part of their routine clinical care
Exclusion Criteria
- Patient pregnant
- Contraindications to metoclopramide including:
- allergic reaction
- pheochromocytoma
- QTc prolongation
- history of seizure disorder
- extrapyramidal symptoms
Data sourced from ClinicalTrials.gov (NCT03331965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.