Head and Neck CancerNCT02937610
Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon
An observational study of Head and Neck Cancer and Percutaneous Endoscopic Gastrostomy, run by University of Helsinki.
Trial summary
PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Read more about this study
- Who is it for?
- Ages 31 to 89 years
- Conditions the study is for
- Head and Neck Cancer, Percutaneous Endoscopic Gastrostomy, Complication
- What is being tested?
- percutaneous endoscopic gastrostomy
- Type of treatment
- Surgery or procedure
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2013
- Phase
- Observational
- 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 31 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 127 consecutive head and neck cancer patients, who underwent PEG placement at the Department of ORL - HNS, Helsinki University Hospital, between October 2011 and May 2013.
Who may be able to join
- head and neck cancer as a underlying disease
Who cannot join
- -
About this study
Official title: Prospective Experience of Percutaneous Endoscopic Gastrostomy Tubes in an Otolaryngologist Service - Safety and Benefits
PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.
- Being tested
- percutaneous endoscopic gastrostomy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous endoscopic gastrostomyProcedure or surgery
Also called PEG
PEG tube inserted with pull technique
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
Measured: 1 year
mortality
Measured: 1 year
Secondary outcomes (1)
delay
delay from the decision to insert PEG to the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2011
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leif Back, University of Helsinki
- Investigators
- Johanna Ruohoalho, MD, Principal investigator, Otorhinolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937610
- Sponsor's protocol ID
- JR/Helsinki/ORL/3
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Experience of Percutaneous Endoscopic Gastrostomy Tubes in an Otolaryngologist Service - Safety and Benefits
- ClinicalTrials.gov ID
- NCT02937610
- Acronym / sponsor ID
- JR/Helsinki/ORL/3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Oct 2016 (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.
PEG tubes are commonly used to provide nutritional support to patients with head and neck cancer. PEG insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 31 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 127 consecutive head and neck cancer patients, who underwent PEG placement at the Department of ORL - HNS, Helsinki University Hospital, between October 2011 and May 2013.
Key inclusion criteria (1 listed)
- head and neck cancer as a underlying disease
Key exclusion criteria (1 listed)
- -
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 endoscopic gastrostomyAlso: PEGPEG tube inserted with pull technique | Procedure or surgery | – |
Primary outcome
complications
Time frame: 1 year
mortality
Time frame: 1 year
1 secondary outcome
delay
Time frame: 1 year
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 18 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Johanna Ruohoalho, MD principal investigator
Otorhinolaryngology - Head and Neck Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Percutaneous Endoscopic Gastrostomy, run by University of Helsinki.
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 1 inclusion and 1 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
complications (time frame: 1 year). The study lists 2 primary outcomes in all. 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 18 Oct 2016.