Early detection of fistulas after total laryngectomy using cytokine measurement
Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
This study is testing if measuring certain proteins in drainage fluids after throat surgery can help doctors spot problems early and let patients start eating again sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Clermont-Ferrand and 6 other locations) |
| Trial ID | NCT06604494 on ClinicalTrials.gov |
What this trial studies
This study aims to improve rehabilitation outcomes for patients undergoing total laryngectomy by detecting early signs of postoperative fistulas through cytokine measurement in drainage fluids. By analyzing levels of inflammatory cytokines, particularly IL10, on the second postoperative day, the study seeks to determine if low cytokine levels can safely allow for earlier resumption of feeding. This approach could potentially reduce hospital stays and enhance the quality of life for patients recovering from surgery. Patients will be recruited from multiple university hospitals and cancer centers in France, ensuring a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates include adult cancer patients scheduled for total laryngectomy or pharyngolaryngectomy.
Not a fit: Patients who are pregnant, breastfeeding, or have a body mass index less than 18.5 kg/m2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier feeding resumption and improved recovery for patients after total laryngectomy.
How similar studies have performed: While the approach of using cytokine measurement for early detection of complications is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient with cancer requiring a total laryngectomy or pharyngolaryngectomy scheduled after multidisciplinary consultation. * Holder of a social security scheme Exclusion Criteria: Pregnant and breastfeeding women Persons under curatorship, guardianship, legal protection or deprived of liberty Any medical condition deemed by the investigator to be incompatible with the study. Refusal to participate. Body mass index less than 18.5 kg/ m2 \-
Where this trial is running
Clermont-Ferrand and 6 other locations
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de Grenoble — Grenoble, France (Not_yet_recruiting)
- CH Emile Roux — Le Puy-en-Velay, France (Not_yet_recruiting)
- HCL Hôpital Croix Rousse — Lyon, France (Not_yet_recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Not_yet_recruiting)
- CH de Valence — Valence, France (Not_yet_recruiting)
- Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Nicolas Saroul — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.