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)

Launched by REGINA ELENA CANCER INSTITUTE · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to perform surgery for patients with laryngeal cancer who have not responded well to previous treatments like radiation or chemotherapy. Specifically, it looks at two different surgical approaches during a procedure called total laryngectomy, which involves removing the larynx (voice box). One group of patients will have the standard surgery, while the other group will have the surgery with an additional technique that uses a piece of tissue (called a flap) to help close the surgical site. The main goal is to see if using this flap reduces the risk of developing a complication known as a pharyngocutaneous fistula, which is an abnormal connection that can form between the throat and the skin after surgery.

To be eligible for this trial, participants should be adults over 18 years old who have been diagnosed with a return or persistence of laryngeal cancer after receiving radiation or chemotherapy. They must be scheduled for surgery that does not involve removing part of the throat. If you decide to participate, you will be asked to sign a consent form and complete some questionnaires during your visits. The study is currently recruiting participants, and all genders are welcome to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:
• • 1. pre (ChT-)RT staging: cT1/T2/T3 N0/N+;
• • 2. 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;
• • Age \> 18 years;
• • Signature of informed consent and ability to complete in-office questionnaires.
• Exclusion Criteria:
• • 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).