Metoclopramide Versus Placebo for GJ Placement

NCT ID: NCT03331965

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-10-03

Brief 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.

Detailed 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.

Conditions

Radiation Exposure; Enteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Metoclopramide 5 MG/ML Injectable Solution

Intervention Type: DRUG

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. 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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.

Interventions

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.

Intervention Type: DRUG

Saline

A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.

Intervention Type: DRUG

Other Intervention Names

Reglan; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Ronald

Role: PRINCIPAL_INVESTIGATOR

Medical Instructor, Vascular & Interventional Radiology

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 21820533 (View on PubMed)

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. doi: 10.2214/ajr.169.6.9393180. No abstract available.

Reference Type: BACKGROUND

PMID: 9393180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21615438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20970794 (View on PubMed)

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(1):61. doi: 10.1186/s13054-015-0784-1.

Reference Type: BACKGROUND

PMID: 25880172 (View on PubMed)

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. doi: 10.1259/0007-1285-69-828-1130.

Reference Type: BACKGROUND

PMID: 9135468 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 21331127 (View on PubMed)

Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA. 2005 Nov 2;294(17):2228-30. doi: 10.1001/jama.294.17.2228. No abstract available.

Reference Type: BACKGROUND

PMID: 16264167 (View on PubMed)

DuRocher N, Smith TP, Gazda S, Olivas A, Whited K, Langston M, Jones D, Martin JG, Kim CY, Ronald J. Metoclopramide Reduces Fluoroscopy and Procedure Time during Gastrojejunostomy Tube Placement: A Placebo-Controlled Trial. J Vasc Interv Radiol. 2020 Jul;31(7):1143-1147. doi: 10.1016/j.jvir.2020.02.028. Epub 2020 May 23.

Reference Type: DERIVED

PMID: 32457012 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Putman Seed Fund 2017-01

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00081892

Identifier Type: -

Identifier Source: org_study_id