Aortic graft used to rebuild windpipe in thyroid cancer surgery

NCT ID NCT07823686

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2027

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hôpital Avicenne

    Bobigny, Île-de-France Region, 93009 Bobigny Cedex, France

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