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NCT Number: NCT07287865

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

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.

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Key information

Conditions

Laryngeal and Hypopharyngeal Tumors Laryngeal Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical flap

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.

Primary outcomes

  1. The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up

    Time frame: 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

Secondary outcomes

  1. The association between the use of a surgical flap and the incidence of mid to longterm post-operative fistulas

    Time frame: 30 days and at mid to long term.

    The rate of development of a mid to longterm post-operative fistula

  2. Potential correlates of fistulas development both within 30 days and at mid to long term

    Time frame: 30 days and 36 months

    • Demographic and medical history
    • Tumor characteristics
    • Previous tumor treatment
    • Laboratory
    • Perioperative management

  3. The incidence of any post-operative complications

    Time frame: 1-36 months follow-up

    Fistulas and any of the surgical and non surgical complications within 30 days.

    Surgical complications (require reintervention):

    • Necroses
    • Hematoma/hemorrage
    • Neopharyngeal stenosis

    Non surgical Complications:

    • Hypocalcemia
    • Anemia requiring blood transfusion
    • Hypokalemia
    • Pneumonia
    • Cardiac complications
    • Infection

  4. 36 months incidence of tumor related events

    Time frame: 36 months after surgery

    Potential correlates will be:

    • The combination of surgical flap and fistula
    • The lymphnode ratio </≥18 (LNR, calculated as the number of positive lymph nodes divided by the total number of lymph nodes removed, including both positive and negative nodes )
    • Sarcopenia

  5. The prognostic role of both the use of a surgical flap and the development of post-operative fistulas

    Time frame: 36 months after surgery

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: TL&TPL

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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