NCT06604494 Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
| NCT ID | NCT06604494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Cancer, Otorhinolaryngeal |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-02-12 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-02-12 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-pharyngo-laryngectomy fistula is a frequent surgical complication, resulting in delayed patient management and reduced quality of life. A recent study has shown that the appearance of a fistula can be detected early by measuring cytokines (particularly IL10) in postoperative drainage fluids. Resumption of feeding following this surgery varies between postoperative day 5 and postoperative day 15, depending on the team\'s habits. Early refeeding reduces the length of hospital stay and improves patients\' quality of life. The decision to refeed is currently made without any clinical or biological marker of the quality of pharyngeal suture healing. The idea of this study is that good initial healing (evidenced by low levels of inflammatory cytokine in drainage fluids) allows early refeeding without putting the patient at additional risk. Main hypothesis and research objectives Main hypothesis: the determination of cytokines in postoperative drainage fluids (FODP) could be a tool for screening patients at no risk of developing a fistula, and for whom early refeeding (as early as postoperative day 3) could be proposed without exposing the patient to an additional risk of developing a FODP. Study objectives Primary objective: to compare the rate of post-(pharyngo)-total laryngectomy fistula between an early refeeding strategy (3rd or 4th postoperative day) and a late refeeding strategy (current standard of care: 7th postoperative day) in a low-risk fistula group defined according to the level of inflammatory cytokines in drainage fluids on the second postoperative day. Secondary objectives To compare an early versus a late refeeding strategy for patients at low risk of fistula defined according to the level of inflammatory cytokines in drainage fluids on the second postoperative day for: * length of hospital stay, * evolution of nutritional status, * time to postoperative radio-chemotherapy, if indicated postoperatively, * improvement in quality of life, * post-operative complications other than pharyngeal fistula. Evaluation of different strategies left to the investigator\'s choice (continuation of antibiotic therapy, increased delay before resumption of feeding, early resumption of surgery) in the group of patients at high risk of fistula, based on the determination of postoperative cytokines in drainage fluids. Primary endpoint: Pharyngo-cutaneous fistula occurring within 30 days post-operatively (yes/no). Number of subjects: 250 Inclusion criteria Major cancer patient justifying scheduled total laryngectomy or pharyngo-laryngectomy after multidisciplinary consultation. Holder of a social security plan. Non-inclusion criteria Pregnant and breast-feeding women Persons under curatorship, guardianship, safeguard of justice or deprived of liberty. Any medical condition deemed incompatible with the study by the investigator. Refusal to participate. Body mass index less than 18.5 kg/m2
Eligibility 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 \-
Contact & Investigator
Nicolas Saroul
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT06604494 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer, Otorhinolaryngeal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06604494 currently recruiting?
Yes, NCT06604494 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT06604494 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Grenoble, France, Le Puy-en-Velay, France, Lyon, France and 3 additional locations.
Who is sponsoring the NCT06604494 clinical trial?
NCT06604494 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Nicolas Saroul at University Hospital, Clermont-Ferrand. The trial plans to enroll 250 participants.
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