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

January 6, 2022 updated by: Robert Baird, University of British Columbia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose:To compare the efficacy of a non-surgical intervention bundle for the prevention and treatment of persistent gastrocutaneous fistulae.

Hypothesis: The investigators hypothesize that the bundled delivery of 3 non-surgical interventions will reduce the development of GCFs and subsequently the need for surgical closure as compared to an established historical control group.

Justification: Persistent gastrocutaneous fistulae are common complications after gastrostomy tube removal (33%), with the current gold-standard treatment being operative intervention; exposing the child to the risks of anesthesia and surgery. Several non-surgical treatments exist, and have shown promise in small retrospective studies, however their true efficacy is yet to be elucidated through a prospective trial. Non-surgical treatment options include the use of proton-pump inhibitors, topical fibrin glue, silver nitrate application, and collagen plugging. As standard of care, patients may receive one, none or a combination of these non-surgical treatments based on clinician decision.

Objectives: The objective of this study is to prospectively evaluate the efficacy of a bundled delivery of non-surgical adjuncts immediately after gastrostomy tube removal and compare outcomes to the historical rate of GCF development.

Research Design: This study is a prospective observational "pre-post" study, which will compare our intervention arm (non-surgical intervention bundle) with a recently established historical control group (completed systematic review of all reported cases). Baseline data will be entered at the time of enrollment. Assessment of our primary outcome (rate of GCF one month after treatment) and secondary outcomes (including an estimate of treatment cost, complications, treatment satisfaction, and need for further interventions) will be made at standard 2 and 4 week follow-up visits.

Statistical Analysis: Standardized quantitative hypothesis testing will be performed for the primary outcome with the aid of a local biostatistician. Power analysis has been established based on a 50% reduction in GCF development, with a sample size of 100 subjects. Secondary outcomes will be tabulated and subjected to quantitative or qualitative assessment as appropriate.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3V4
        • Recruiting
        • BC Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible for gastrostomy tube removal

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

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
This study investigates a bundle of three commonly used treatments
Other Names:
  • Silver Nitrate
  • Dermabond

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrocutaneous Fistula (GCF)
Time Frame: 1 month
Rate of gastrocutaneous fistula persistence based on clinical assessment
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver satisfaction Survey
Time Frame: 1 month
A 9 question Likert-style (Strongly disagree- Strongly agree) questionnaire evaluating caregiver perceptions of the study
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

St. Justine's Hospital
Montreal Children's Hospital of the MUHC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-02821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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