Laryngeal CancerGRAALNCT04650919
Aortic Laryngeal Rehabilitation Graft
A study testing Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device). in people with Laryngeal Cancer and Total Laryngectomy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production. In the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Cancer, Total Laryngectomy
- What is being tested?
- Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2021to 28 Jul 2026
- 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
- Patient with carcinomatous pathology of the upper airways requiring total laryngectomy
- Patient affiliated to a social health insurance scheme (beneficiary or beneficiary's successor)
- Patient speaks and reads French, understands the objectives and risks of the research and is able to provide dated and signed informed consent.
- Patient having been informed of the results of the prior medical examination
- For a woman with the ability to procreate: negative blood pregnancy test (verified during preoperative blood work) and effective contraception throughout the study.
Who cannot join
- Patient with a contraindication to general anaesthesia and/or iodinated contrast agents
- Breastfeeding woman
- Patient with a WHO performance index of grade strictly greater than 2 at the inclusion visit
- Patient with subglottic or basi-lingual tumour extension greater than 1 cm (by endoscopic control and CT scan)
- Patient having undergone cervico-facial radiotherapy prior to surgical management
- Patient suffering from severe coagulation disorders (checked during the blood test performed as part of the standard care to make the diagnosis of cancer)
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- Patient with a history of allergy to DMSO, DHEA, clindamycin, gentamicin, vancomycin used for graft treatment and preservation
- Inability to give informed information about the patient (patient in emergency situations, difficulties in understanding the patient)
- Patient in exclusion period (determined by a previous or ongoing study)
- Patient under safeguard of justice
- Patient under guardianship,curatorship, family guardianship
- Any situation considered by the operating physician as falling under a non-inclusion criterion
- Patient suffering from a decompensated psychiatric pathology or at risk of decompensation, which may interfere with the follow-up modalities in the research setting.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ENT department-Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Christian DEBRY, MD PhD
Christian DEBRY, MD PhD
About this study
Official title: Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function
The larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production.
In the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of life, not so much because of the loss of voice, but because of the presence of a definitive tracheostoma with particularly deleterious consequences.
Read more
The majority of the work of the different teams around the world has focused on restoring phonatory function, but no technique - apart from the artificial larynx developed in the ENT department of the Hautepierre Hospital - has yet succeeded in removing the tracheotomy orifice, requiring the restoration of a common passage between the respiratory and swallowing passages. If nutrition and phonatory function can still be supplemented after such an operation (oesophageal rehabilitation, implant placed between the trachea and oesophagus), natural breathing is no longer possible. Patients are forced to wear a permanent tracheotomy opening.
There are currently only 2 ways to try to restore all the functions of the larynx after total laryngectomy: i) laryngeal transplantation, but this procedure requires maintaining immunosuppressive treatment, which is not possible in patients suffering from cancer of the larynx, which is not a vital organ, ii) artificial larynx made of biomaterials (titanium), the first cases of which were performed worldwide in the ENT department of the Strasbourg University Hospital in 2012, results published in the NEJM (API 2008-2009 HUS No. 4493- IDRCB No.: 2011-A00032-39. However, difficulties were encountered with the use of the titanium prosthesis due to the bulk and rigidity of the removable and non-removable part, which caused residual swallowing difficulties (false routes).
It is now possible, due to the development of new allograft techniques in humans for tracheal replacement (studies published on a large number of cases with several years of hindsight, cf. references), to switch to the "all biological" using an aortic graft stented with a silicone stent. We wish to use these grafts in laryngeal restoration after total laryngectomy by our team, while exploiting all the data and experience acquired (unique in the world) within the ENT department of Hautepierre Hospital. This new conceptual leap should make it possible to significantly improve the patient's quality of life and the performance previously acquired in clinical trials on the artificial larynx in its entirety (breathing, phonation) or partially (swallowing).
The investigators thus propose to evaluate this new artificial larynx in aortic allograft, the objective of which is to supplement the respiratory, swallowing and phonation functions in patients laryngectomized for carcinological causes.
- Conditions
- Laryngeal Cancer, Total Laryngectomy
- Being tested
- Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).
- Keywords
- laryngectomy
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).Procedure or surgery
The procedure consists of 2 operating times:
- Surgery S1 (1st surgical procedure): total laryngectomy and placement of the stented aortic graft (human tissue + device: NOVATECH GSS TM (trademark) TD), under tracheotomy cover.
- Surgery S2 (2nd surgical procedure) (between S1 +24 weeks and S1 +36 weeks) : opening of the proximal part of the graft by endoscopic way with maintenance of the tracheotomy orifice to ensure patient safety.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Procedure: Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or Failure of the procedure
The primary endpoint is composite, combining clinically assessments:
- the score on the Respiratory Function Assessment (clinically assessed : 0: no dyspnea, to 3 (major dyspnea) and
- the score (0-3) on the Swallowing Ability Assessment (0: no issue to 3: major food misdirection) assessed by nasofibroscopy.
The procedure will be considered a success if :
- respiratory function: no dyspnea (score=0) or moderate dyspnea (score=1) AND
- swallowing ability: no false-route (score=0) or moderate false-route (score=1)
In all other cases, the procedure will be considered a failure.
Measured: 6 month following the second surgery (Month 6; Visit 6)
Secondary outcomes (4)
Scoring of dyspnea at each follow-up visit
Score on the Respiratory Function Assessment (clinically assessed : 0: no dyspnea, to 3 (major dyspnea)
Measured: 1 to 8 days and15 days following the second surgery (Visit 3), Month 1 (Visit 4), Month 3 (Visit 5), Month 6 (Visit 6), Month 9 (Visit 7) and Month 12 (Visit 8)
Scoring of swallowing ability assessment at each follow-up visit
Score (0-3) on the Swallowing Ability Assessment (0: no issue to 3: major food misdirection) assessed by nasofibroscopy.
Measured: 8 days and 15 days following the second surgery (Visit 3), Month 1 (Visit 4), Month 3 (Visit 5), Month 6 (Visit 6), Month 9 (Visit 7) and Month 12 (Visit 8)
Evaluation of the patient's voice by the "Voice Handicap Index 30" (Pommée, 2018)
The Voice Handicap Index is a scale where the patient grades the severity of his disorder by 10 items on a scale from 0 (never) to 4 (always). Close to 0 may consider that the disability is almost nil, close to 120 the patient's voice has a significant impact on his or her daily life.
Measured: 8 days and 15 days following the second surgery (Visit 3), Month 1 (Visit 4), Month 3 (Visit 5), Month 6 (Visit 6), Month 9 (Visit 7) and Month 12 (Visit 8)
Analysis of Adverse Events and Serious adverse Events throughout the study
Measured: From the signature of the consent form (inclusion visit) to the end of study visit, up to 28 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start29 Mar 2021
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Christian DEBRY, MD PhD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650919
- Sponsor's protocol ID
- 7649
- Acronym
- GRAAL
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2020
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function
- ClinicalTrials.gov ID
- NCT04650919
- Acronym / sponsor ID
- GRAAL / 7649
- Conditions
- Laryngeal Cancer, Total Laryngectomy
- Keywords
- laryngectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 3 Dec 2020 (actual)
- 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 larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production.
In the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of life, not so much because of the loss of voice, but because of the presence of a definitive tracheostoma with particularly deleterious consequences.
The majority of the work of the different teams around the world has focused on restoring phonatory function, but no technique - apart from the artificial larynx developed in the ENT department of the Hautepierre Hospital - has yet succeeded in removing the tracheotomy orifice, requiring the restoration of a common passage between the respiratory and swallowing passages. If nutrition and phonatory function can still be supplemented after such an operation (oesophageal rehabilitation, implant placed between the trachea and oesophagus), natural breathing is no longer possible. Patients are forced to wear a permanent tracheotomy opening.
There are currently only 2 ways to try to restore all the functions of the larynx after total laryngectomy: i) laryngeal transplantation, but this procedure requires maintaining immunosuppressive treatment, which is not possible in patients suffering from cancer of the larynx, which is not a vital organ, ii) artificial larynx made of biomaterials (titanium), the first cases of which were performed worldwide in the ENT department of the Strasbourg University Hospital in 2012, results published in the NEJM (API 2008-2009 HUS No. 4493- IDRCB No.: 2011-A00032-39. However, difficulties were encountered with the use of the titanium prosthesis due to the bulk and rigidity of the removable and non-removable part, which caused residual swallowing difficulties (false routes).
It is now possible, due to the development of new allograft techniques in humans for tracheal replacement (studies published on a large number of cases with several years of hindsight, cf. references), to switch to the "all biological" using an aortic graft stented with a silicone stent. We wish to use these grafts in laryngeal restoration after total laryngectomy by our team, while exploiting all the data and experience acquired (unique in the world) within the ENT department of Hautepierre Hospital. This new conceptual leap should make it possible to significantly improve the patient's quality of life and the performance previously acquired in clinical trials on the artificial larynx in its entirety (breathing, phonation) or partially (swallowing).
The investigators thus propose to evaluate this new artificial larynx in aortic allograft, the objective of which is to supplement the respiratory, swallowing and phonation functions in patients laryngectomized for carcinological causes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with carcinomatous pathology of the upper airways requiring total laryngectomy
- Patient affiliated to a social health insurance scheme (beneficiary or beneficiary's successor)
- Patient speaks and reads French, understands the objectives and risks of the research and is able to provide dated and signed informed consent.
- Patient having been informed of the results of the prior medical examination
- For a woman with the ability to procreate: negative blood pregnancy test (verified during preoperative blood work) and effective contraception throughout the study.
Key exclusion criteria (13 listed)
- Patient with a contraindication to general anaesthesia and/or iodinated contrast agents
- Breastfeeding woman
- Patient with a WHO performance index of grade strictly greater than 2 at the inclusion visit
- Patient with subglottic or basi-lingual tumour extension greater than 1 cm (by endoscopic control and CT scan)
- Patient having undergone cervico-facial radiotherapy prior to surgical management
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 |
|---|---|---|
| Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).The procedure consists of 2 operating times: * Surgery S1 (1st surgical procedure): total laryngectomy and placement of the stented aortic graft (human tissue + device: NOVATECH GSS TM (trademark) TD), under tracheotomy cover. * Surgery S2 (2nd surgical procedure) (between S1 +24 weeks and S1 +36 weeks) : opening of the proximal part of the graft by endoscopic way with maintenance of the tracheotomy orifice to ensure patient safety. | Procedure or surgery | Experimental arm |
Primary outcome
Success or Failure of the procedure
Time frame: 6 month following the second surgery (Month 6; Visit 6)
The primary endpoint is composite, combining clinically assessments: * the score on the Respiratory Function Assessment (clinically assessed : 0: no dyspnea, to 3 (major dyspnea) and * the score (0-3) on the Swallowing Ability Assessment (0: no issue to 3: major food misdirection) assessed by nasofibroscopy. The procedure will be considered a success if : * respiratory function: no dyspnea (score=0) or moderate dyspnea (score=1) AND * swallowing ability: no false-route (score=0) or moderate false-route (score=1) In all other cases, the procedure will be considered a failure.
4 secondary outcomes
Scoring of dyspnea at each follow-up visit
Time frame: 1 to 8 days and15 days following the second surgery (Visit 3), Month 1 (Visit 4), Month 3 (Visit 5), Month 6 (Visit 6), Month 9 (Visit 7) and Month 12 (Visit 8)
Scoring of swallowing ability assessment at each follow-up visit
Time frame: 8 days and 15 days following the second surgery (Visit 3), Month 1 (Visit 4), Month 3 (Visit 5), Month 6 (Visit 6), Month 9 (Visit 7) and Month 12 (Visit 8)
Evaluation of the patient's voice by the "Voice Handicap Index 30" (Pommée, 2018)
Time frame: 8 days and 15 days following the second surgery (Visit 3), Month 1 (Visit 4), Month 3 (Visit 5), Month 6 (Visit 6), Month 9 (Visit 7) and Month 12 (Visit 8)
Analysis of Adverse Events and Serious adverse Events throughout the study
Time frame: From the signature of the consent form (inclusion visit) to the end of study visit, up to 28 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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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.
Christian DEBRY, MD PhD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device). in people with Laryngeal Cancer and Total Laryngectomy, run by University Hospital, Strasbourg, France 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian DEBRY, MD PhD (+33 (0)3 88 12 76 44, christian.debry@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success or Failure of the procedure (time frame: 6 month following the second surgery (Month 6; Visit 6)). 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 13 Dec 2022.