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)

Larynx Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287034
• Other study ID #: RS1833/23
• Status: Recruiting
• Start date: March 21, 2023
• Est. completion date: September 21, 2025

Study information

• Verified date: February 2024
• Source: Regina Elena Cancer Institute
• Contact: Raul Pellini, Doctor
• Phone: 06-52664484
• Email: raul.pellini[@]ifo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: September 21, 2025
• Est. primary completion date: March 21, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Fistula
• Larynx Carcinoma

Intervention

Procedure:
• Primary suture
The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaires for evaluation of the quality of life	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).	30 months
Secondary	Identification of risk factors	Identification of risk factors related to the formation of pharyngocutaneous fistulas after salvage total laryngectomy	4 months
Secondary	Evaluation of swallowing function	Evaluation of swallowing function assessed using the SOAL questionnaire	4 months
Secondary	Evaluation of vocal rehabilitation	Evaluation of vocal rehabilitation using the SECEL questionnaire	4 months