A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children

NCT03920306 | Completed Phase 4

• 1 other identifier: H17-02821
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrostomy tube placement is a common surgery, and involves placing a tube from the child's skin to the inside of their stomach, allowing an alternative route for nutrition and medication to patients who cannot tolerate oral intake. A common complication of gastrostomy tubes is the development of a persistent connection between the stomach and skin after their removal. This is called a gastrocutaneous fistula (GCF). Non-surgical options have shown some success in eliminating the need for surgery to close these fistulae. Their true efficacy is unknown however; this study evaluates a non-surgical intervention bundle in the prevention and treatment of GCFs.

Conditions

Gastrostomy Complications; Gastrocutaneous Fistula

Keywords

gastrostomy

Outcome Measures

Primary Outcomes (1)

• Gastrocutaneous Fistula (GCF)

  Rate of gastrocutaneous fistula persistence based on clinical assessment

  1 month

Other Outcomes (1)

• Caregiver satisfaction Survey

  1 month

Study Arms (1)

Intervention

EXPERIMENTAL

Drug administration for the experimental arm includes: 1. AgNO3 applied to the fistula tract. 2. A topical adhesive of either 2-Octylcyanoacrylate glue (Dermabond), or Fibrin glue, or Histoacryl glue (Tissue Seal), will be applied over the fistula's aperture. 3. Oral anti-reflux therapy of either Pantoprazole 20-40mg PO OD, or Ranitidine 5-10mg/kg/day PO divided twice daily or 150mg PO BID, for either 4 weeks or until gastrocutaneous fistula tract closure, whichever comes first.

Drug: oral anti-acid treatment

Interventions

oral anti-acid treatment DRUG

This study investigates a bundle of three commonly used treatments

Also known as: Silver Nitrate, Dermabond

Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Eligible for gastrostomy tube removal

You may not qualify if:

• Recurrent gastrocutaneous fistula
• Non-consenting
• Unable to comply with follow up assessments
• Known allergic reaction to study products

Sponsors & Collaborators

• Montreal Children's Hospital of the MUHC: collaborator
• University of British Columbia: lead
• St. Justine's Hospital: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H3V4, Canada

Location

Related Publications (1)

• St-Louis E, Safa N, Guadagno E, Baird R. Gastrocutaneous fistulae in children - A systematic review and meta-analysis of epidemiology and treatment options. J Pediatr Surg. 2018 May;53(5):946-958. doi: 10.1016/j.jpedsurg.2018.02.022. Epub 2018 Feb 8.

  PMID: 29506816 RESULT

MeSH Terms

Interventions

Silver Nitrate; octyl 2-cyanoacrylate

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Single prospective arm; historical control

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: April 1, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)