Squamous Cell Carcinoma of OropharynxNCT02035735
Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
A study testing WL and NBI in people with Squamous Cell Carcinoma of Oropharynx and Squamous Cell Carcinoma of Hypopharynx, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx
- What is being tested?
- WL and NBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Oct 2017
- 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
- Patients who can benefit a laryngoscopic exam under general anesthesia
Who cannot join
- General anesthesia contra-indications
- Local anesthesia allergy
- Breast-feeding period or pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx
The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.
Read the detailed description
Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.
To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.
After surgery, surgical margins were evaluated and healthy margins were measured.
- Conditions
- Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx
- Being tested
- WL and NBI
- Keywords
- NBI,, squamous cell carcinoma,, pharynx, larynx, surgical margins.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Laryngeal Diseases, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WL and NBIProcedure or surgery
For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).
| Study group | Role | What they receive |
|---|---|---|
| Videoendoscopy with WL and NBI | Experimental | The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI). Receives: Procedure: WL and NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients for whom superficial extension of the tumors has been increased by NBI.
Measured: 4 minutes
Secondary outcomes (4)
Number of tumors upstaged.
Measured: 4 minutes
Contribution of the NBI in the diagnosis of other synchronous locations.
Measured: 4 minutes
Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Measured: 4 minutes
Contribution of the NBI in the evaluation of surgical margins.
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of OropharynxStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien VERGEZ, MD, PhD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035735
- Sponsor's protocol ID
- 13 203 02
- Status last verified
- Dec 2018
- First submitted
- 10 Jan 2014
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.
PubMed 33398548
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx
- ClinicalTrials.gov ID
- NCT02035735
- Acronym / sponsor ID
- 13 203 02
- Conditions
- Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Squamous Cell Carcinoma of Larynx
- Keywords
- NBI,, squamous cell carcinoma,, pharynx, larynx, surgical margins.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Jan 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.
The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.
Detailed description
Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.
To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.
After surgery, surgical margins were evaluated and healthy margins were measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videoendoscopy with WL and NBI | Experimental | Procedure: WL and NBIThe day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who can benefit a laryngoscopic exam under general anesthesia
Key exclusion criteria (3 listed)
- General anesthesia contra-indications
- Local anesthesia allergy
- Breast-feeding period or pregnancy
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 |
|---|---|---|
| WL and NBIFor each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI). | Procedure or surgery | Videoendoscopy with WL and NBI |
Primary outcome
Number of patients for whom superficial extension of the tumors has been increased by NBI.
Time frame: 4 minutes
4 secondary outcomes
Number of tumors upstaged.
Time frame: 4 minutes
Contribution of the NBI in the diagnosis of other synchronous locations.
Time frame: 4 minutes
Contribution of the NBI in the diagnosis of pre-neoplastic lesions.
Time frame: 4 minutes
Contribution of the NBI in the evaluation of surgical margins.
Time frame: 4 minutes
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 11 Dec 2018.
- Derived from this study: PubMed 33398548Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.
- 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.
Sébastien VERGEZ, MD, PhD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WL and NBI in people with Squamous Cell Carcinoma of Oropharynx and Squamous Cell Carcinoma of Hypopharynx, run by University Hospital, Toulouse at 1 site in France.
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 3 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 11 Dec 2018. 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 France. 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?
Number of patients for whom superficial extension of the tumors has been increased by NBI. (time frame: 4 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035735, which also lists 1 linked publication.
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 11 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.