Comparison of Percutaneous Image-guided Gastrostomies

Study Overview
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Brief Summary
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Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating gastroenteric access through the anterior abdominal wall for nutrition and/ or compression. Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop catheters via the push technique are both used at Interventional Radiology for PIG at our institution. To date, there is no guideline for PIG and no direct comparison of two PIG techniques. The proposed pilot study is to compare the two different types of PIG techniques in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose of the study is to assess the feasibility of a large randomized clinical trial to compare these two PIG techniques.

Official Title
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Comparison of Percutaneous Image-guided Gastrostomies: A Single Centre Pilot Study

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Procedure: percutaneous image-guided gastrostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years; Life expectancy > 6 months; Diagnosed with head and neck cancer; and Scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite. Exclusion Criteria: Pregnancy; or Established pharyngeal obstruction and/or presence of an enteral feeding device.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastrostomy - pull technique<br>Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique | Procedure: percutaneous image-guided gastrostomy<br> <br> |
| Active Comparator: Gastrostomy - push technique<br>Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique | Procedure: percutaneous image-guided gastrostomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain experience | The primary objective of this study is to compare the level of pain experienced, measured by the dose of sedation used during the procedure, and numerical rating scale (NRS) | pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | successful placement of percutaneous image-guided gastrostomy | Day 0 post procedure | 
| Catheter malfunction rate | tube clogging, dislodgement and/or leakage | Up to six months post procedure | 
| Tube site complications | Skin infection on tube exit | Up to six months post procedure | 
| Quality of life | Quality of life for patients undergoing different types of PIG procedures. | Up to six weeks post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, Percutaneous image-guided gastrostomy, Pain, Quality of life, Complication