Cancer of Head and Neck
Conditions
Keywords
Head and neck cancer, Percutaneous image-guided gastrostomy, Pain, Quality of life, Complication
Brief summary
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.
Interventions
PROCEDUREpercutaneous image-guided gastrostomy
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥18 years; 2. Life expectancy \> 6 months; 3. Diagnosed with head and neck cancer; and 4. Scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite.
Exclusion criteria
1. Pregnancy; or 2. Established pharyngeal obstruction and/or presence of an enteral feeding device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain experience | pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Day 0 post procedure | successful placement of percutaneous image-guided gastrostomy |
| Catheter malfunction rate | Up to six months post procedure | tube clogging, dislodgement and/or leakage |
| Tube site complications | Up to six months post procedure | Skin infection on tube exit |
| Quality of life | Up to six weeks post procedure | Quality of life for patients undergoing different types of PIG procedures. |
Countries
Canada
Outcome results
None listed