Comparison of Percutaneous Image-guided Gastrostomies

Cancer of Head and Neck Clinical Trial

Official title:

Comparison of Percutaneous Image-guided Gastrostomies: A Single Centre Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053428
• Other study ID #: 12-0298B
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: November 14, 2014
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Procedure:
• percutaneous image-guided gastrostomy

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Technical success	successful placement of percutaneous image-guided gastrostomy	Day 0 post procedure	No
Secondary	Catheter malfunction rate	tube clogging, dislodgement and/or leakage	Up to six months post procedure	Yes
Secondary	Tube site complications	Skin infection on tube exit	Up to six months post procedure	Yes
Secondary	Quality of life	Quality of life for patients undergoing different types of PIG procedures.	Up to six weeks post procedure	No