Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy

NCT ID: NCT07287865

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2030-12-31

Brief Summary

Salvage total laryngectomy (TL) and total pharyngolaryngectomy (TPL) are the gold standard for most recurrent laryngeal and hypopharyngeal tumors as well as in patients with contraindication for chemoradiotherapy (CRT). Free or pedicled flaps are the two mandatory options for pharyngeal reconstruction after TPL, while remain an optional indication to protect the neopharynx after TL. The most common complication after TL or TPL is pharyngocutaneous fistula (PCF), with an incidence ranging from 3% to 65%, according to the surgical defect and type of reconstruction. The etiology of PCF is multifactorial and the most important risk factors are a history of CRT, low hemoglobin levels (< 12.5 g/dl), and malnutrition. A growing concern is the role of nutritional status, with sarcopenia as an emergent risk factor for post-operative complications, because muscle wasting negatively influences wound healing and overall recovery. Salivary stent placement, 3-layers neopharyngeal sutures, cricopharyngeal myotomy and prophylactic use of vascularized flaps are possible protective factors to reduce the risk of PCF. Despite these evidences, it remains unclear which are the best candidates for flap reconstruction, as well as which preoperative risk factors influence the risk of PCF.

The rationale of this ambispective monocentric study is to identify the risk factors statistically significant associated with the development of PCF and the influence of preoperative sarcopenia on postoperative complications risks following TL and TPL.

Conditions

Laryngeal and Hypopharyngeal Tumors

Study Design

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

Study Groups

reconstructive flap

patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with reconstructive flap, from January 2015 to December 2030

surgical flap

Intervention Type: PROCEDURE

Pedicled or free flap was harvested and placed over the pharyngeal suture (on-lay) following TL or tunnelled to reconstruct wide defects (in-lay) after TPL.

NO reconstructive flap

patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy,without reconstructive flap, from January 2015 to December 2030

No interventions assigned to this group

Interventions

surgical flap

Pedicled or free flap was harvested and placed over the pharyngeal suture (on-lay) following TL or tunnelled to reconstruct wide defects (in-lay) after TPL.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Patients undergoing to TL with direct closure of the pharynx or TPL and reconstruction of the pharynx with a free or pedicled flap in cases of:

• Naive laryngeal neoplasia (cT1-cT4a with possible extension to the esophagus, oropharynx, or hypopharynx);
• Recurrence of laryngeal or hypopharyngeal cancer in patients previously treated with surgical intervention (TLM/CO2 laser or OPHL);
• Recurrence of laryngeal or hypopharyngeal cancer in patients previously treated with RT or CRT;
• Loss of laryngeal function induced by RT, CRT, or OPHL treatment;
• Availability of data according to the assessments that must be made, including a follow-up period of at least 2 months.

Exclusion Criteria

• Lack of useful data to carry out the assessments related to the study itself

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

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Marco Benazzo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Benazzo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Locations

SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia

Pavia, Pavia, Italy

Countries

Italy

Other Identifiers

TL&TPL

Identifier Type: -

Identifier Source: org_study_id