Comparison of Percutaneous Image-guided Gastrostomies

University Health Network, Toronto

Status: Completed

Conditions: Cancer of Head and Neck

Treatments: Procedure: percutaneous image-guided gastrostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02053428

12-0298B

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Gastrostomy - pull technique

Active Comparator group

Description:

Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique

Treatment:

Procedure: percutaneous image-guided gastrostomy

Gastrostomy - push technique

Active Comparator group

Description:

Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique

Treatment:

Procedure: percutaneous image-guided gastrostomy