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Clinical Trials in Italy / NCT07287865
Active, not recruiting Observational

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

NCT07287865 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2025-03-14
Last updated
2025-12-17

Condition(s) studied

Laryngeal and Hypopharyngeal Tumors

Investigational drug(s) / intervention(s)

surgical flap

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up — within 30 days from surgery
    Proportion of subjects who develop a post-operative fistula (blind or pharyngo-cutaneous fistula, PCF, with or without the use of a surgical flap, which develop within 30 days from surgery

Trial sites (1)

FacilityCityRegionStatus
SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia Pavia Pavia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07287865 on ClinicalTrials.gov ↗ ← All trials in Italy