Metoclopramide Versus Placebo for GJ Placement

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.

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