Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604494
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Rehabilitation Improved by Early Detection of Fisyulas Post Pharyngo -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADEFILAC
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 team39s habits Early refeeding reduces the length of hospital stay and improves patients39 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 investigator39s 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 yesno
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 185 kgm2
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 investigator39s 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 yesno
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 185 kgm2
Detailed Description:
Course of the study Patients will be recruited from the ENT departments of the Clermont Ferrand Saint-Etienne Lyon and Grenoble university hospitals the Lyon Centre Léon Bérard and Paris Institut Gustave Roussy cancer centers and the Le Puy En Velay and Valence hospitals all of which are accredited for cervico-facial carcinology
A multidisciplinary consultation meeting will be required to validate the surgical procedure
Patients will be informed of the study by the investigating physician After a period of reflection and a chance to answer any questions the patient will be included in the study after consent has been obtained from an investigator
The main risk factors for the development of a fistula will be recorded pre- and intraoperatively
Surgical criteria will be common to all investigating teams The most important of these will be the positioning of the LDPO collection drain opposite the pharyngeal closure site The drain may or may not be aspirative depending on local habits The concomitant insertion of a phonatory prosthesis or a salivary bypass are not grounds for exclusion
Post-operative care must meet precise specifications Drainage fluids will be collected from the drainage bottle on D2 post-op To do this the entire drainage bottle will be recovered and a new bottle will be placed over the drain if the drain is retained
The liquid contained in the drainage bottle is then sterile-separated into different samples directly in the patient39s hospital ward
Immunological sampling A BD Falcon Conical Tubes 50 mL will be sent to the immunology laboratory associated with the investigating center Clermont-Ferrand University Hospital Immunology Laboratory for the Clermont-Fd and Le Puy en Velay sites Lyon University Hospital Immunology Laboratory for the Grenoble Lyon Valence and Lyon anti-cancer center the immunology laboratory of the Assistance Publique Hopitaux de Paris for the Gustave Roussy Institute and the immunology laboratory for the Saint-Etienne center The sample is then centrifuged at 3000 rpm for 10 minutes at 4Ca high-risk group for CPE
Bacteriological sampling This sample will be sent rapidly to the bacteriology laboratory of the investigating center for standard cyto-bacteriological analysis
For an IL 10 level on D2 post-op of less than 72pgmL so-called low-risk fistula group defined from the DEFILAC pilot study two groups of patients will be constituted
Low-risk fistula group OPT performed on D3 or D4 before randomization and after IL-10 results If TPO classified according to van la Parra 1 patients will be randomized into 2 groups
EARLY group Resumption of feeding on postoperative day 3 or 4 with a liquid or mixed diet
TARDIF group return to a mixed diet from day 7 post-op Randomization will be centralized computerized with random block sizes stratified by center and patient age
If the TOP shows images classified according to van la Parragt1 patients will join the so-called high-risk CPE exploratory arm
If IL10 levels on D2 post-op exceed 72 pgmL high-risk group for post-op fistula these patients will form a third exploratory group whose management will be left to the investigator39s choice with 3 possibilities no change in investigators39 habits repeat surgery to clean the surgical site and repair the pharyngeal sutures broad-spectrum antibiotic therapy while awaiting the bacteriological results of the cytobacteriological examination of the drainage fluid on postoperative day 2 without repeat surgery monitoring and no change in the investigator39s routine
Postoperative complications will then be noted and classified according to the Clavien-Dindo classification over a period of 30 postoperative days
The appearance of a salivary fistula at the tracheostoma will be objectified by the appearance of saliva in the tracheostoma The appearance of a fistula at the cervical level will be sought either by imaging methods in the event of a cervical complication infection hemorrhage if no surgical revision is decided and surgically by loss of sealing confirmed surgically if a revision is necessary
The appearance of a subsequent fistula will be noted The patient will have a final consultation 30 days after surgery if he or she is no longer hospitalized
The quality of life of the patients will be assessed throughout the study by completing an anxiety questionnaire and a depression questionnaire This assessment will be done before surgery on D5 D15 and D30 of surgery Before surgery and at D5 these questionnaires will be completed during hospitalization At D15 and D30 the questionnaires will be completed during hospitalization if the patient is still hospitalized or by mail if the patient has been discharged from the surgical department having performed the pharyngolaryngectomy procedure The date of the start of chemoradiotherapy will then be noted and the time between surgery and the start of this treatment will be noted
A multidisciplinary consultation meeting will be required to validate the surgical procedure
Patients will be informed of the study by the investigating physician After a period of reflection and a chance to answer any questions the patient will be included in the study after consent has been obtained from an investigator
The main risk factors for the development of a fistula will be recorded pre- and intraoperatively
Surgical criteria will be common to all investigating teams The most important of these will be the positioning of the LDPO collection drain opposite the pharyngeal closure site The drain may or may not be aspirative depending on local habits The concomitant insertion of a phonatory prosthesis or a salivary bypass are not grounds for exclusion
Post-operative care must meet precise specifications Drainage fluids will be collected from the drainage bottle on D2 post-op To do this the entire drainage bottle will be recovered and a new bottle will be placed over the drain if the drain is retained
The liquid contained in the drainage bottle is then sterile-separated into different samples directly in the patient39s hospital ward
Immunological sampling A BD Falcon Conical Tubes 50 mL will be sent to the immunology laboratory associated with the investigating center Clermont-Ferrand University Hospital Immunology Laboratory for the Clermont-Fd and Le Puy en Velay sites Lyon University Hospital Immunology Laboratory for the Grenoble Lyon Valence and Lyon anti-cancer center the immunology laboratory of the Assistance Publique Hopitaux de Paris for the Gustave Roussy Institute and the immunology laboratory for the Saint-Etienne center The sample is then centrifuged at 3000 rpm for 10 minutes at 4Ca high-risk group for CPE
Bacteriological sampling This sample will be sent rapidly to the bacteriology laboratory of the investigating center for standard cyto-bacteriological analysis
For an IL 10 level on D2 post-op of less than 72pgmL so-called low-risk fistula group defined from the DEFILAC pilot study two groups of patients will be constituted
Low-risk fistula group OPT performed on D3 or D4 before randomization and after IL-10 results If TPO classified according to van la Parra 1 patients will be randomized into 2 groups
EARLY group Resumption of feeding on postoperative day 3 or 4 with a liquid or mixed diet
TARDIF group return to a mixed diet from day 7 post-op Randomization will be centralized computerized with random block sizes stratified by center and patient age
If the TOP shows images classified according to van la Parragt1 patients will join the so-called high-risk CPE exploratory arm
If IL10 levels on D2 post-op exceed 72 pgmL high-risk group for post-op fistula these patients will form a third exploratory group whose management will be left to the investigator39s choice with 3 possibilities no change in investigators39 habits repeat surgery to clean the surgical site and repair the pharyngeal sutures broad-spectrum antibiotic therapy while awaiting the bacteriological results of the cytobacteriological examination of the drainage fluid on postoperative day 2 without repeat surgery monitoring and no change in the investigator39s routine
Postoperative complications will then be noted and classified according to the Clavien-Dindo classification over a period of 30 postoperative days
The appearance of a salivary fistula at the tracheostoma will be objectified by the appearance of saliva in the tracheostoma The appearance of a fistula at the cervical level will be sought either by imaging methods in the event of a cervical complication infection hemorrhage if no surgical revision is decided and surgically by loss of sealing confirmed surgically if a revision is necessary
The appearance of a subsequent fistula will be noted The patient will have a final consultation 30 days after surgery if he or she is no longer hospitalized
The quality of life of the patients will be assessed throughout the study by completing an anxiety questionnaire and a depression questionnaire This assessment will be done before surgery on D5 D15 and D30 of surgery Before surgery and at D5 these questionnaires will be completed during hospitalization At D15 and D30 the questionnaires will be completed during hospitalization if the patient is still hospitalized or by mail if the patient has been discharged from the surgical department having performed the pharyngolaryngectomy procedure The date of the start of chemoradiotherapy will then be noted and the time between surgery and the start of this treatment will be noted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None