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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
University Health Network
Toronto, Ontario, Canada
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)
Time frame: pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure
Technical success
successful placement of percutaneous image-guided gastrostomy
Time frame: Day 0 post procedure
Catheter malfunction rate
tube clogging, dislodgement and/or leakage
Time frame: Up to six months post procedure
Tube site complications
Skin infection on tube exit
Time frame: Up to six months post procedure
Quality of life
Quality of life for patients undergoing different types of PIG procedures.
Time frame: Up to six weeks post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.