Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day

NCT06604494 | Recruiting

• 2 other identifiers: PHRCI 2022 SAROUL2024-A00652-45
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 7

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

Conditions

Cancer, Otorhinolaryngeal

Keywords

total laryngectomy

Outcome Measures

Primary Outcomes (1)

• Pharyngocutaneous fistula occurring within 30 days postoperatively

  Apparition or not of Pharyngocutaneous fistula occurring within 30 days postoperatively (yes/no).

  Day 30

Secondary Outcomes (23)

• Hospitalization time in days.

  Day 30

• Evolution of Weight in kg

  Day 30

• Nutrition Risk INdex

  Day 30

• Measure of grip strenght

  Day 30

• Deadlines for the implementation of post-operative radio-chemotherapy

  Day 30

Study Arms (3)

Early group

EXPERIMENTAL

For an IL 10 level on postoperative day 2 below 72 pg/mL (group said to be at low risk of developing a fistula defined from the DEFILAC pilot study), resumption of food on the 3rd or 4th postoperative day with a mixed diet.

Behavioral: early feeding resumption

late group

PLACEBO COMPARATOR

For an IL 10 level on postoperative day 2 below 72 pg/mL (group said to be at low risk of developing a fistula defined from the DEFILAC pilot study), resumption of food on the 3rd or 4th postoperative day with a mixed diet.

Behavioral: late feeding resumption

No intervention

NO INTERVENTION

For an IL 10 level on postoperative day 2 greater than 72 pg/mL (group at high risk of postoperative fistula), these patients will constitute a third, exploratory group, whose management will be left to the investigator's discretion.

Interventions

early feeding resumption BEHAVIORAL

Resumption of food on the 3rd or 4th day post-operatively with a mixed diet.

Early group

late feeding resumption BEHAVIORAL

Resumption of food on the 7th day post-operatively with a mixed diet.

late group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient with cancer requiring a total laryngectomy or pharyngolaryngectomy scheduled after multidisciplinary consultation.
• Holder of a social security scheme

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (7)

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

MeSH Terms

Conditions

Otorhinolaryngologic Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Nicolas Saroul

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)