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)

NCT06287034 | Recruiting

• 1 other identifier: RS1833/23
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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)

Conditions

Larynx Carcinoma

Keywords

pharyngocutaneous fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identification of risk factors

  4 months

• Evaluation of swallowing function

  4 months

• Evaluation of vocal rehabilitation

  4 months

Study Arms (2)

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.

Procedure: Primary suture

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.

Procedure: Primary suture

Interventions

Primary suture 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; Salvage total laryngectomy STL primary suture + onlay flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histological confirmation of recurrence/persistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:
• pre (ChT-)RT staging: cT1/T2/T3 N0/N+;
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Raul Pellini, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raul Pellini, Doctor

CONTACT

06-52664484; raul.pellini@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 29, 2024
• Study Start: March 21, 2023
• Primary Completion: March 21, 2025
• Study Completion: September 21, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

IT (1)