An interventional study of percutaneous image-guided gastrostomy in Cancer of Head and Neck, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-17.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 60 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique
Procedure: percutaneous image-guided gastrostomy
Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique
Procedure: percutaneous image-guided gastrostomy
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
The record gives a start of Jun 2013, a primary completion of Apr 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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