Aortic graft used to rebuild windpipe in thyroid cancer surgery
NCT ID NCT07823686
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers test a new surgical approach for thyroid cancer that has invaded the windpipe. They replace the affected section with a preserved aortic graft supported by a silicone stent. The goal is to remove all cancer and improve survival. The trial includes patients whose cancer cannot be treated with standard resection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tracheal replacement using a cryopreserved aortic allograft supported by a silicone stent
- What this could lead to
- If it works, this could offer a way to completely remove thyroid cancer that has grown into the windpipe, something current treatments rarely achieve.
- What could go wrong
- The surgery is complex and experimental, and the graft may fail to integrate or lead to complications. The trial is small and early, so results may not apply broadly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Study inclusion criteria will be approved by a multidisciplinary tumor board (local or national, e.g., TUTHYREF, if necessary) and will include the following: * patients with thyroid cancer involving the trachea and/or cricoid cartilage that is not amenable to simple resection-anastomosis, regardless of prior treatment status; * patients with any histological type of thyroid cancer, excluding the undifferentiated/anaplastic type; * patients deemed eligible for surgical resection based on standard preoperative assessment; * lesions considered unresectable via standard procedures; * women using effective contraception throughout the study duration, in accordance with CTCG recommendations. Exclusion Criteria: * age under 18 years; * patients unable to provide consent; * patients not covered by the French Social Security system; * patients with undifferentiated/anaplastic thyroid cancer; * patients for whom standard preoperative assessment precludes surgical resection (e.g., severe malnutrition, limiting cardiovascular disease, limiting respiratory disease with DLCO \< 35% or VO2max \< 10 ml/min/kg); * patients with \*de novo\* thyroid cancer and minimal tracheal invasion suitable for simple resection-anastomosis; * patients with \*RET\* mutations; * pregnant or breastfeeding women; * patients participating in another interventional study; * patients under legal guardianship or trusteeship. Note that for patients with metastatic disease, the decision regarding inclusion or exclusion will be made on a case-by-case basis during the multidisciplinary team (MDT) meeting; contraindications to standardized tracheal resection and primary anastomosis reconstruction will be determined by the MDT; and all histological types-including medullary carcinoma-will be included, with the exception of undifferentiated/anaplastic types, to ensure a homogeneous group regarding local invasion and prognosis. Note also that minimal invasion (\<2 cm)-in the absence of repeat surgery, and regardless of the presence or absence of recurrent laryngeal nerve paralysis-requires resection-anastomosis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Avicenne
Bobigny, Île-de-France Region, 93009 Bobigny Cedex, France
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