Metoclopramide Versus Placebo for GJ Placement

Enteral Nutrition Clinical Trial

Official title:

A Randomized Controlled Trial of Metoclopramide Versus Placebo During Gastrojejunostomy Tube Placement for Facilitating Guidewire Advancement Through the Pylorus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331965
• Other study ID #: Pro00081892
• Secondary ID: Putman Seed Fund
• Status: Completed
• Phase: Phase 2
• Start date: April 9, 2018
• Est. completion date: October 3, 2019

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 3, 2019
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Nutrition
• Radiation Exposure

Intervention

Drug:
• Metoclopramide 5 MG/ML Injectable Solution
A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement.
• Saline
A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bai Y, Guo JF, Li ZS. Meta-analysis: erythromycin before endoscopy for acute upper gastrointestinal bleeding. Aliment Pharmacol Ther. 2011 Jul;34(2):166-71. doi: 10.1111/j.1365-2036.2011.04708.x. Epub 2011 May 25. — View Citation

Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011. — View Citation

Donnelly LF, Klosterman LA, Ball WS Jr, Bisset GS 3rd. Comparison of duodenal intubation techniques during conversion of gastrostomy to gastrojejunostomy tubes in children. AJR Am J Roentgenol. 1997 Dec;169(6):1633-4. — View Citation

Hu B, Ye H, Sun C, Zhang Y, Lao Z, Wu F, Liu Z, Huang L, Qu C, Xian L, Wu H, Jiao Y, Liu J, Cai J, Chen W, Nie Z, Liu Z, Chen C. Metoclopramide or domperidone improves post-pyloric placement of spiral nasojejunal tubes in critically ill patients: a prospective, multicenter, open-label, randomized, controlled clinical trial. Crit Care. 2015 Feb 13;19:61. doi: 10.1186/s13054-015-0784-1. — View Citation

Itkin M, DeLegge MH, Fang JC, McClave SA, Kundu S, d'Othee BJ, Martinez-Salazar GM, Sacks D, Swan TL, Towbin RB, Walker TG, Wojak JC, Zuckerman DA, Cardella JF; Society of Interventional Radiology; American Gastroenterological Association Institute; Canadian Interventional Radiological Association; Cardiovascular and Interventional Radiological Society of Europe. Multidisciplinary practical guidelines for gastrointestinal access for enteral nutrition and decompression from the Society of Interventional Radiology and American Gastroenterological Association (AGA) Institute, with endorsement by Canadian Interventional Radiological Association (CIRA) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Gastroenterology. 2011 Aug;141(2):742-65. doi: 10.1053/j.gastro.2011.06.001. — View Citation

Lyon SM, Pascoe DM. Percutaneous gastrostomy and gastrojejunostomy. Semin Intervent Radiol. 2004 Sep;21(3):181-9. doi: 10.1055/s-2004-860876. — View Citation

Paul N, Rawlinson J, Keir M. The use of metoclopramide for the small bowel meal examination: pre-procedural versus peri-procedural oral administration. Br J Radiol. 1996 Dec;69(828):1130-3. — View Citation

Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA. 2005 Nov 2;294(17):2228-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects Experiencing Adverse Effects in the Periprocedural Period	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.	Up to 30 days after procedure.
Primary	Time to Duodenal Intubation	The fluoroscopy time required to advance a guidewire through the pylorus.	Up to 45 minutes.
Secondary	Total Procedure Fluoroscopy Time	The total procedure fluoroscopy time.	Up to 1 hour.
Secondary	Total Procedure Air Kerma	The total procedure Air Kerma (energy released in a unit mass of air) measured in milligray (mGy).	Up to 1 hour.
Secondary	Total Procedure Time	The total procedure time.	Up to 1 hour.