Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification.

Laryngeal Cancer Clinical Trial

Official title:

Study of the Risk of Pharyngocutaneous Fistula (PCF) in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification (Fistula-score)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308016
• Other study ID #: 25/IRE/23
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Regina Elena Cancer Institute
• Contact: Raul Pellini, Doctor
• Phone: 06 5266 6765
• Email: raul.pellini[@]ifo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria.

Description:

Evaluate the relative weight of each factor pre-operative risk, in order to build a score (fistula-score) to be able to stratify before surgery surgical total laryngectomy patients in low-risk and high-risk PCF pharyngocutaneous fistula. Analyze and process data relating to a total of approximately 500 patients underwent, consecutively, total laryngectomy for malignant neoplasm of the larynx The results obtained from the present study will allow patients to be stratified into low and high risk for PCF to undergo total laryngectomy, so as to reduce this surgical complication

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients undergoing LT surgery with direct closure of the pharynx in case of:

• naïve laryngeal neoplasm (cT1-T3 and cT4a without extension to the esophagus or hypopharynx or oropharynx);
• recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (CO2 laser limited within the larynx or OPHL);
• recurrence of laryngeal neoplasm after RT or Ch-RT treatment;
• lack of functionality of the larynx induced by (Ch-)RT treatment;
• Availability of data according to the assessments that will have to be made, including a FU period of 2 months.

Exclusion Criteria:

• Use of flap, pedicled / free, on-lay / in-lay at the same time as LT surgery. Patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.

Related Conditions & MeSH terms

• Fistula
• Laryngeal Cancer
• Laryngeal Neoplasms

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of risk factors	The primary objective of the project is the identification of pre-operative risk factors	12 months
Secondary	Stratify patients	The secondary objective is to construct a score to stratify patients according to the risk of developing PCF	12 months