The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)

Eligibility criteria

Qualifiers

pre (ChT-)RT staging: cT1/T2/T3 N0/N+;

pre STL staging: rcT1/cT2/ Selected cT3 cT4a (extension to thyroid cartilage and/or prelaryngeal tissues) N0/N+ (clinically and radiologically).

Indication for STL surgery (no pharyngeal mucosal resection);

Functional total laryngectomies after radical (chemo-)radiotherapy treatment;

Disqualifiers

STL extended to the pharynx and/or total pharyngeal laryngectomies;

Extension of the tumor to the pharyngeal mucosa and/or massive extra-laryngeal extension;

Previous open organ preservation surgery (OPHL).

Trial design

Treatments tested in this trial

  • Primary suture

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators