Evaluating flap use in laryngectomy after failed cancer treatment
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)
This study is testing if using a special flap during surgery for throat cancer helps reduce the risk of complications and improves recovery for patients who have already had treatment that didn't work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06287034 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, randomized study aims to assess the risk of pharyngocutaneous fistula (PCF) in patients undergoing salvage total laryngectomy (STL) for laryngeal carcinoma after failure of (chemo-)radiotherapy. Participants will be randomly assigned to two groups: one receiving STL with primary suture and the other receiving STL with an additional onlay flap technique. The study will collect demographic, clinical, and perioperative data, and patients will complete questionnaires four months post-surgery to evaluate quality of life related to voice and swallowing rehabilitation. The goal is to determine if the flap technique reduces the risk of PCF compared to primary suture alone.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed recurrence of laryngeal squamous cell carcinoma who have undergone prior (chemo-)radiotherapy.
Not a fit: Patients with extensive tumor involvement requiring total pharyngeal laryngectomies or those who have had previous organ preservation surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of complications following laryngectomy, improving recovery and quality of life for patients.
How similar studies have performed: While similar studies have explored surgical techniques in laryngectomy, this specific approach using flap reinforcement is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Raul Pellini, Doctor — IRCCS "Regina Elena" National Cancer Institute
- Study coordinator: Raul Pellini, Doctor
- Email: raul.pellini@ifo.it
- Phone: 06-52664484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.