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

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ClinicalTrials.gov Identifier: NCT03920306
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Montreal Children's Hospital of the MUHC
St. Justine's Hospital
Dalhousie University
University of Saskatchewan
Information provided by (Responsible Party):
Robert Baird, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrocutaneous Fistula Drug: oral anti-acid treatment Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single prospective arm; historical control
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Gastrocutaneous Fistula (GCF) [ Time Frame: 1 month ]
    Rate of gastrocutaneous fistula persistence based on clinical assessment


Other Outcome Measures:
  1. Caregiver satisfaction Survey [ Time Frame: 1 month ]
    A 9 question Likert-style (Strongly disagree- Strongly agree) questionnaire evaluating caregiver perceptions of the study


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920306


Contacts
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Contact: Robert Baird, MDCM 6048752667 robert.baird@cw.bc.ca
Contact: Christine Adamson 604-875-7720 cadamson@cw.bc.ca

Locations
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Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H3V4
Contact: Robert Baird, MDCM    6048752667    robert.baird@cw.bc.ca   
Sponsors and Collaborators
University of British Columbia
Montreal Children's Hospital of the MUHC
St. Justine's Hospital
Dalhousie University
University of Saskatchewan
More Information
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Publications of Results:

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Responsible Party: Robert Baird, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03920306    
Other Study ID Numbers: H17-02821
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastric Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
 Digestive System Diseases
Silver Nitrate
Anti-Infective Agents, Local
Anti-Infective Agents