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Comparison of Percutaneous Image-guided Gastrostomies

NCT ID: NCT02053428

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer of Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastrostomy - pull technique

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

Group Type ACTIVE_COMPARATOR

percutaneous image-guided gastrostomy

Intervention Type PROCEDURE

Gastrostomy - push technique

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

Group Type ACTIVE_COMPARATOR

percutaneous image-guided gastrostomy

Intervention Type PROCEDURE

Interventions

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percutaneous image-guided gastrostomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kong Teng Tan, MB BCH BAO

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-0298B

Identifier Type: -

Identifier Source: org_study_id