Early detection of fistulas after total laryngectomy using cytokine measurement
Official title: Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
Run by University Hospital, Clermont-Ferrand · NCT06604494 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Clermont-Ferrand and 6 other locations) |
| Status | Recruiting |
| Started | February 12, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | September 22, 2025 |
| Trial ID | NCT06604494 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult cancer patients scheduled for total laryngectomy or pharyngolaryngectomy.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Show 1 more location
-
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 take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.