Metoclopramide Versus Placebo for GJ Placement
Keywords
Abstract
Description
Gastrojejunostomy tube placement is a commonly performed procedure for providing nutritional support in patients unable to tolerate gastric feeds due to gastric outlet or duodenal obstruction or severe gastroesophageal reflux. When performed percutaneously, this procedure involves advancing a guidewire from the gastrostomy skin entry site through the pylorus. Based on data collected for quality improvement purposes the investigators have found that this step accounts for approximately one half the total fluoroscopy time and radiation dose during GJ tube placement and approximately one third of the total physician time in the procedure. Specifically, crossing the pylorus required on average 5.3 minutes of fluoroscopy time out of a total of 9.3 minutes for the entire procedure, and accounted for 92.2 mGy air kerma out of 201.7 mGy for the entire procedure. Furthermore, inability to advance a wire into the duodenum due to refractory pylorospasm is among the most common reasons for aborting GJ placement. Specifically, in approximately 1.5% of GJ placement procedures the pylorus cannot be crossed and a gastrostomy tube is placed instead. Only colonic interposition, in which GJ tube placement is not attempted, accounts for a larger fraction of failed procedures (3%). A variety of wire, catheter, and device related techniques have been described to facilitate wire intubation of the pylorus, but this remains a rate limiting step in the procedure. In order to reduce radiation doses to both the patient and interventional radiologist to levels that are as low as reasonably achievable and to maximize procedural success rates, adjunctive methods to aid in wire intubation of the pylorus are needed.
Previous meta-analyses of randomized controlled trials have found that a single dose of erythromycin or metoclopramide is effective at emptying the stomach of blood and improving visualization during endoscopy for upper gastrointestinal tract bleeding. Similarly, a previous randomized controlled trial demonstrated that a single dose of metoclopramide or domperidone increases the rate at which nasoenteric tubes spontaneously pass through the pylorus from 27 to 55%. Single dose metoclopramide is also indicated for reducing transit time during small bowel follow through examinations. Drug related adverse events in these studies were rare.
Although single dose promotility agents are established in the above described settings, they have not been studied for GJ tube placement. The investigators hypothesize that use of promotility agents may facilitate advancement of the guidewire through the duodenum and into the proximal jejunum during GJ tube placement by enhancing gastric peristalsis, pylorus relaxation, and small bowel motility. Single doses of promotility agents such as metoclopramide are inexpensive (approximately $1.02 per dose), easily administered at the time of the procedure, and have very favorable safety profiles. Therefore, promotility agents may represent a simple, effective, and readily feasible means of reducing radiation dose and procedure time during GJ tube placement, thus improving the safety and efficiency of this common IR procedure.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 10/29/2017 |
| Estimated Enrollment Submitted: | 10/31/2017 |
| First Posted: | 11/05/2017 |
| Last Update Submitted: | 06/22/2020 |
| Last Update Posted: | 07/12/2020 |
| Date of first submitted results: | 06/22/2020 |
| Date of first submitted QC results: | 06/22/2020 |
| Date of first posted results: | 07/12/2020 |
| Actual Study Start Date: | 04/08/2018 |
| Estimated Primary Completion Date: | 10/02/2019 |
| Estimated Study Completion Date: | 10/02/2019 |
Condition or disease
Intervention/treatment
Drug: Metoclopramide
Drug: Saline
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Metoclopramide A one-time dose of promotility agent (2 mL of Metoclopramide 5 MG/ML Injectable Solution in 8 mL saline IV) will be administered at the time of GJ placement. After administration of the pro-motility drug, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion. | Drug: Metoclopramide A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement. |
| Placebo Comparator: Saline A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. After administration of the placebo, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion. | Drug: Saline A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Time to Duodenal Intubation [Up to 45 minutes.]
Secondary Outcome Measures
1. Total Procedure Fluoroscopy Time [Up to 1 hour.]
2. Total Procedure Air Kerma [Up to 1 hour.]
3. Total Procedure Time [Up to 1 hour.]
Other Outcome Measures
1. Number of Subjects Experiencing Adverse Effects in the Periprocedural Period [Up to 30 days after procedure.]
