Comparison of Percutaneous Image-guided Gastrostomies

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Procedure: percutaneous image-guided gastrostomy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gastrostomy - pull technique; Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique	Procedure: percutaneous image-guided gastrostomy
Active Comparator: Gastrostomy - push technique; Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique	Procedure: percutaneous image-guided gastrostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	successful placement of percutaneous image-guided gastrostomy	Day 0 post procedure
Catheter malfunction rate	tube clogging, dislodgement and/or leakage	Up to six months post procedure
Tube site complications	Skin infection on tube exit	Up to six months post procedure
Quality of life	Quality of life for patients undergoing different types of PIG procedures.	Up to six weeks post procedure

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Kong Teng Tan, MB BCH BAO, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Head and neck cancer; Complication; Percutaneous image-guided gastrostomy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 12-0298B