NCT02053428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 17, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

January 21, 2014

Last Update Submit

November 14, 2014

Conditions

Cancer of Head and Neck

Keywords

Head and neck cancerPercutaneous image-guided gastrostomyPainQuality of lifeComplication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Technical success

    Day 0 post procedure

  • Catheter malfunction rate

    Up to six months post procedure

  • Tube site complications

    Up to six months post procedure

  • Quality of life

    Up to six weeks post procedure

Study Arms (2)

Gastrostomy - pull technique

ACTIVE COMPARATOR

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

Procedure: percutaneous image-guided gastrostomy

Gastrostomy - push technique

ACTIVE COMPARATOR

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

Procedure: percutaneous image-guided gastrostomy

Interventions

percutaneous image-guided gastrostomyPROCEDURE
Gastrostomy - pull techniqueGastrostomy - push technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy; or
  • Established pharyngeal obstruction and/or presence of an enteral feeding device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kong Teng Tan, MB BCH BAO

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

February 3, 2014

Study Start

June 1, 2013

Primary Completion

April 1, 2014

Study Completion

October 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-01

Locations

CA(1)