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Comparison of Percutaneous Image-guided Gastrostomies

Primary Purpose

Cancer of Head and Neck

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
percutaneous image-guided gastrostomy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Head and Neck focused on measuring Head and neck cancer, Percutaneous image-guided gastrostomy, Pain, Quality of life, Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gastrostomy - pull technique

Gastrostomy - push technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Technical success
successful placement of percutaneous image-guided gastrostomy
Catheter malfunction rate
tube clogging, dislodgement and/or leakage
Tube site complications
Skin infection on tube exit
Quality of life
Quality of life for patients undergoing different types of PIG procedures.

Full Information

First Posted
January 21, 2014
Last Updated
November 14, 2014
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02053428
Brief Title
Comparison of Percutaneous Image-guided Gastrostomies
Official Title
Comparison of Percutaneous Image-guided Gastrostomies: A Single Centre Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Head and Neck
Keywords
Head and neck cancer, Percutaneous image-guided gastrostomy, Pain, Quality of life, Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastrostomy - pull technique
Arm Type
Active Comparator
Arm Description
Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique
Arm Title
Gastrostomy - push technique
Arm Type
Active Comparator
Arm Description
Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique
Intervention Type
Procedure
Intervention Name(s)
percutaneous image-guided gastrostomy
Primary Outcome Measure Information:
Title
Pain experience
Description
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)
Time Frame
pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure
Secondary Outcome Measure Information:
Title
Technical success
Description
successful placement of percutaneous image-guided gastrostomy
Time Frame
Day 0 post procedure
Title
Catheter malfunction rate
Description
tube clogging, dislodgement and/or leakage
Time Frame
Up to six months post procedure
Title
Tube site complications
Description
Skin infection on tube exit
Time Frame
Up to six months post procedure
Title
Quality of life
Description
Quality of life for patients undergoing different types of PIG procedures.
Time Frame
Up to six weeks post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥18 years; Life expectancy > 6 months; Diagnosed with head and neck cancer; and Scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite. Exclusion Criteria: Pregnancy; or Established pharyngeal obstruction and/or presence of an enteral feeding device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MB BCH BAO
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

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Comparison of Percutaneous Image-guided Gastrostomies

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