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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastrostomy - pull technique | Active Comparator | Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique |
|
| Gastrostomy - push technique | Active Comparator | Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous image-guided gastrostomy | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kong Teng Tan, MB BCH BAO | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |