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)

NCT ID: NCT06287034

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-09-21

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.

Conditions

Larynx Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Salvage total laryngectomy STL primary suture

Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing.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)31. It would be preferable for all centers to use a homogeneous pharyngeal suture technique, such as the T-shaped with Connell suture.

Primary suture

Intervention Type: PROCEDURE

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)

Salvage total laryngectomy STL primary suture + onlay flap

Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing, but in the patients of the second group, in addition, the positioning of a free/pedunculated covering flap will also be carried out with the onlay technique. Reconstruction with the onlay technique can be performed using a pedicled pectoralis major myofascial flap or anterolateral thigh myofascial free flap at the surgeon's discretion (pharyngeal suture unchanged). The flap will be positioned with an onlay technique to reinforce the pharyngeal suture and in turn sutured to the prevertebral fascia or residual surrounding tissues.

Primary suture

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raul Pellini, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raul Pellini, Doctor

Role: CONTACT

raul.pellini@ifo.it

06-52664484 ext. +39

Facility Contacts

Pellini Raul, Doctor

Role: primary

raul.pellini@ifo.it

06-52664484

Other Identifiers

RS1833/23

Identifier Type: -

Identifier Source: org_study_id