Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy

NCT07644325 — Not applicable, Recruiting, 500 participants, Clinique Saint Jean, France

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Assessment of Diagnostic Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy in Patients Who Underwent Endoscopic Carpal Tunnel Syndrome Surgery

Registry	NCT07644325, acronym ATTR2026
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	500 (Estimated)
Sponsor	Clinique Saint Jean, France (Other)
Conditions	Carpal Tunnel, Transthyretin Amyloidosis
Interventions	Annular ligament biopsy (Diagnostic test)
Dates	start 2026-05-27, primary completion 2027-05-27 (estimated), completion 2027-05-27 (estimated), first posted 2026-06-12, last updated 2026-06-12
Locations	1 site in France

-Summary

Transthyretin amyloidosis (ATTR) is an underdiagnosed condition that can present early as carpal tunnel syndrome, sometimes preceding cardiac involvement by several years. The recent emergence of new treatments underscores the importance of early diagnosis. Synovial biopsy performed during open carpal tunnel surgery is considered the gold standard for local screening, but it is less accessible, more difficult, and riskier to perform via endoscopy-a minimally invasive surgical technique that is currently the standard at our center and is becoming increasingly widespread.

The anterior annular ligament of the carpus constitutes an alternative tissue to the synovium, easily accessible via endoscopy, safe, and standardizable.

In this study, the systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during endoscopic carpal tunnel surgery would allow for the evaluation of the diagnostic concordance of the ligament biopsy by comparing it to the results obtained using the gold standard method. This strategy would also provide an opportunity to analyze the feasibility of systematic screening for ATTR on the ligament during endoscopic procedures.

This approach could offer a practical and innovative method for the early identification of at-risk patients and facilitate appropriate and timely management of the condition.

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+Arms and interventions

Arm	Type	Interventions	Description
Annular ligament biopsy in conjunction with a synovial biopsy	Other	Diagnostic Test: Annular ligament biopsy	For all patients, systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during the surgery

Annular ligament biopsy (Diagnostic test): In addition to the standard synovial biopsy, a biopsy of the annular ligament of the carpus will be performed during endoscopic carpal tunnel surgery

+Outcome measures

Primary outcomes

agreement between the gold standard and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery. [up to 3 weeks]: To assess the agreement between the gold standard (synovial biopsy) and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.

Secondary outcomes

Assessment and description of the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery. [Perioperative/Periprocedural]: To evaluate and describe the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery. Feasibility will be assessed by the proportion of procedures in which a biopsy specimen of the anterior annular ligament of the carpus can be successfully obtained and submitted for histopathological analysis during endoscopic carpal tunnel surgery.
Safety Assessment of Ligament Biopsy [up to 24hours]: Assess the safety of ligament biopsy, particularly with regard to specific complications.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult patient with Health Insurance
* Clinical diagnosis + carpal tunnel EMG
* Validated indication for carpal tunnel surgery
* Signed informed consent
* Patient at risk for postoperative complications (bilateral carpal tunnel syndrome, heart failure, atrial fibrillation, elderly patients)

Exclusion Criteria:

* Need for open carpal tunnel surgery.
* Pregnant women
* Adults under guardianship

+Locations (1)

Facility	City	Country	Status
Clinique St Jean Sud de france	Montpellier	France	Recruiting