Laryngeal and Hypopharyngeal TumorsTL&TPLNCT07287865
Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy
An observational study of Laryngeal and Hypopharyngeal Tumors, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal and Hypopharyngeal Tumors
- What is being tested?
- surgical flap
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with or without reconstructive flap, at Fondazione IRCCS Policlinico San Matteo from January 2015 to December 2030
Who may be able to join
- 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.
Who cannot join
- Lack of useful data to carry out the assessments related to the study itself
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia
Pavia, Pavia, 27100
About this study
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
- Being tested
- surgical flap
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical flapProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: surgical flap | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up
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
Measured: within 30 days from surgery
Secondary outcomes (5)
The association between the use of a surgical flap and the incidence of mid to longterm post-operative fistulas
The rate of development of a mid to longterm post-operative fistula
Measured: 30 days and at mid to long term.
Potential correlates of fistulas development both within 30 days and at mid to long term
- Demographic and medical history
- Tumor characteristics
- Previous tumor treatment
- Laboratory
- Perioperative management
Measured: 30 days and 36 months
The incidence of any post-operative complications
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
Measured: 1-36 months follow-up
36 months incidence of tumor related events
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
Measured: 36 months after surgery
The prognostic role of both the use of a surgical flap and the development of post-operative fistulas
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start14 Mar 2025
- Primary completionDec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal and Hypopharyngeal TumorsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Benazzo, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Marco Benazzo, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287865
- Sponsor's protocol ID
- TL&TPL
- Acronym
- TL&TPL
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy
- ClinicalTrials.gov ID
- NCT07287865
- Acronym / sponsor ID
- TL&TPL / TL&TPL
- Conditions
- Laryngeal and Hypopharyngeal Tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reconstructive flap | – | Procedure: surgical flappatients 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with or without reconstructive flap, at Fondazione IRCCS Policlinico San Matteo from January 2015 to December 2030
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Lack of useful data to carry out the assessments related to the study itself
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical flapPedicled 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. | Procedure or surgery | reconstructive flap |
Primary outcome
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
5 secondary outcomes
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.
Potential correlates of fistulas development both within 30 days and at mid to long term
Time frame: 30 days and 36 months
The incidence of any post-operative complications
Time frame: 1-36 months follow-up
36 months incidence of tumor related events
Time frame: 36 months after surgery
The prognostic role of both the use of a surgical flap and the development of post-operative fistulas
Time frame: 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Benazzo, MD principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal and Hypopharyngeal Tumors, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.