Metoclopramide Versus Placebo for GJ Placement

NCT03331965 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro00081892Putman Seed Fund 2017-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Exposure; Enteral Nutrition

Keywords

Interventional Radiology; Metoclopramide; Gastrojejenostomy

Outcome Measures

Primary Outcomes (1)

• Time to Duodenal Intubation

  The fluoroscopy time required to advance a guidewire through the pylorus.

  Up to 45 minutes.

Secondary Outcomes (3)

• Total Procedure Fluoroscopy Time

  Up to 1 hour.

• Total Procedure Air Kerma

  Up to 1 hour.

• Total Procedure Time

  Up to 1 hour.

Other Outcomes (1)

• Number of Subjects Experiencing Adverse Effects in the Periprocedural Period

  Up to 30 days after procedure.

Study Arms (2)

Metoclopramide

EXPERIMENTAL

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 5 MG/ML Injectable Solution

Saline

PLACEBO COMPARATOR

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

Interventions

Metoclopramide 5 MG/ML Injectable Solution 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.

Also known as: Reglan

Metoclopramide

Saline DRUG

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

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• undergoing de novo GJ placement as part of their routine clinical care

You may not qualify if:

• Patient pregnant
• Contraindications to metoclopramide including:
• allergic reaction
• pheochromocytoma
• QTc prolongation
• history of seizure disorder
• extrapyramidal symptoms

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (9)

• 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. No abstract available.

  PMID: 21820533 BACKGROUND

• 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.

  PMID: 9393180 BACKGROUND

• 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.

  PMID: 21615438 BACKGROUND

• 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.

  PMID: 20970794 BACKGROUND

• 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.

  PMID: 25880172 BACKGROUND

• 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.

  PMID: 9135468 BACKGROUND

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

  PMID: 21331127 BACKGROUND

• 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.

  PMID: 16264167 BACKGROUND

• 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.

  PMID: 32457012 DERIVED

MeSH Terms

Interventions

Metoclopramide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. James Ronald
• Organization: Duke University Medical Center

james.ronald@duke.edu

919.684.7299

Study Officials

• James Ronald

  Medical Instructor, Vascular & Interventional Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: April 9, 2018
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: July 13, 2020
• Results First Posted: July 13, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)