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Completed

NCT Number: NCT02053428

Comparison of Percutaneous Image-guided Gastrostomies

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.

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Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

percutaneous image-guided gastrostomy

Procedure

Primary outcomes

  1. Pain experience

    Time frame: pre, 1-hour, 2-hour, 3-hour, 1-day, 2-day, 3-day and weekly for up to six weeks post procedure

    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 outcomes

  1. Technical success

    Time frame: Day 0 post procedure

    successful placement of percutaneous image-guided gastrostomy

  2. Catheter malfunction rate

    Time frame: Up to six months post procedure

    tube clogging, dislodgement and/or leakage

  3. Tube site complications

    Time frame: Up to six months post procedure

    Skin infection on tube exit

  4. Quality of life

    Time frame: Up to six weeks post procedure

    Quality of life for patients undergoing different types of PIG procedures.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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