Comparison of Percutaneous Image-guided Gastrostomies

Not Applicable

Completed

• Conditions: Cancer of Head and Neck
• Interventions: Procedure: percutaneous image-guided gastrostomy

• Registration Number: NCT02053428
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Primary Completion: 2014-04
• Study Completion: 2014-10
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastrostomy - pull technique	percutaneous image-guided gastrostomy	Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique
Gastrostomy - push technique	percutaneous image-guided gastrostomy	Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada