Clinical trial NCT06287034: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Larynx Carcinoma
Keywords: pharyngocutaneous fistula
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from recurrence/persistence of laryngeal SCC following exclusive RT treatment or concomitant RT/ChT without extension to the pharynx (rcT1/T2/T3 selected rcT4a N0/N+) who will have to undergo STL and who will meet the following criteria. Patients undergoing extensive laryngectomies or with disease with even partial involvement of the pharyngeal mucosa (pyriform sinus, posterior wall of the pharynx) will not be included.

Brief summary: 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)

Detailed description: Patients, once eligibility has been verified, will then be randomized (1:1) to one of the following groups: Gruop 1: STL primary suture. Group 2: STL primary suture + onlay flap Patients in both groups will then undergo surgery STL with primary suture; in those of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. 4 months after surgery, questionnaires will be administered to the patient for the subjective evaluation of the quality of life in relation to vocal rehabilitation obtained through voice prosthesis or esophageal voice (SECEL questionnaire) and swallowing rehabilitation (SOAL questionnaire). Demographic and preoperative data will be collected, data relating to pre-(chemo-)radiotherapy and pre-STL clinical staging, as well as the interval in days between the end of (chemo-)radiotherapy and surgery, perioperative data, type of eventual unilateral or bilateral laterocervical lymph node emptying, the type of pharyngotomy suture, the type of flap possibly used, the packaging of the tracheoesophageal fistula for positioning the voice prosthesis, the definitive histological examination.

The patient must undergo a radiological examination for loco-regional and distant staging before the STL (CT or MRI) and a biopsy demonstrating the recurrence/persistence of the disease.

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).

Primary outcomes:
measure: questionnaires for evaluation of the quality of life
timeFrame: 30 months
Secondary outcomes:
measure: Identification of risk factors
timeFrame: 4 months
measure: Evaluation of swallowing function
timeFrame: 4 months
measure: Evaluation of vocal rehabilitation
timeFrame: 4 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Raul Pellini, Doctor
role: PRINCIPAL_INVESTIGATOR
References: