Cancer of Head and NeckNCT02053428
Comparison of Percutaneous Image-guided Gastrostomies
A study testing percutaneous image-guided gastrostomy in people with Cancer of Head and Neck, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- percutaneous image-guided gastrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy; or
- Established pharyngeal obstruction and/or presence of an enteral feeding device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer of Head and Neck
- Being tested
- percutaneous image-guided gastrostomy
- Keywords
- Head and neck cancer, Percutaneous image-guided gastrostomy, Pain, Quality of life, Complication
- Medical subject headings
- Head and Neck Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous image-guided gastrostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gastrostomy - pull technique | Active comparator | Percutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique Receives: Procedure: percutaneous image-guided gastrostomy |
| Gastrostomy - push technique | Active comparator | Percutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique Receives: Procedure: percutaneous image-guided gastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
successful placement of percutaneous image-guided gastrostomy
Measured: Day 0 post procedure
Catheter malfunction rate
tube clogging, dislodgement and/or leakage
Measured: Up to six months post procedure
Tube site complications
Skin infection on tube exit
Measured: Up to six months post procedure
Quality of life
Quality of life for patients undergoing different types of PIG procedures.
Measured: Up to six weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kong Teng Tan, MB BCH BAO, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053428
- Sponsor's protocol ID
- 12-0298B
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Percutaneous Image-guided Gastrostomies: A Single Centre Pilot Study
- ClinicalTrials.gov ID
- NCT02053428
- Acronym / sponsor ID
- 12-0298B
- Conditions
- Cancer of Head and Neck
- Keywords
- Head and neck cancer, Percutaneous image-guided gastrostomy, Pain, Quality of life, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrostomy - pull technique | Active comparator | Procedure: percutaneous image-guided gastrostomyPercutaneous image-guided gastrostomy using large-bore mushroom-retained catheters via the pull technique |
| Gastrostomy - push technique | Active comparator | Procedure: percutaneous image-guided gastrostomyPercutaneous image-guided gastrostomy using small-bore cope loop catheters via the push technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnancy; or
- Established pharyngeal obstruction and/or presence of an enteral feeding device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous image-guided gastrostomy | Procedure or surgery | Gastrostomy - pull technique, Gastrostomy - push technique |
Primary outcome
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)
4 secondary outcomes
Technical success
Time frame: Day 0 post procedure
Catheter malfunction rate
Time frame: Up to six months post procedure
Tube site complications
Time frame: Up to six months post procedure
Quality of life
Time frame: Up to six weeks post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kong Teng Tan, MB BCH BAO principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous image-guided gastrostomy in people with Cancer of Head and Neck, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.