Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04842968
Status:
UNKNOWN
Last Update Posted:
2021-04-13
First Post:
2021-04-05
Brief Title:
Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer
Sponsor:
St Borbala Hospital
Organization:
St Borbala Hospital
Study Overview
Official Title:
The Impact of ex Vivo Intra-arterial Methylene Blue Injection on Nodal Staging Accuracy and Survival in Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB
Brief Summary:
Nodal staging holds both important prognostic and predictive value at colorectal cancer Regional lymph nodes are located close to the primary tumor in the mesocolon mesorectum Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging accuracy criteria
In order to reach this number of lymph nodes a precise surgical technique total mesorectal excision or complete mesocolic excision as well as a thorough pathological specimen work-up is needed
The aim of the study is to investigate if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist hence leading to a better staging and hopefully even to a better outcome in the long run
In 2014-2015 two surgical centers randomised resected colorectal specimens in 11 ratio to methylene-blue injection arm and control no injection arm in a total of 200 consecutive cases Both pathologic and oncologic treatment were led regardless of the injection reports were just routinely saved in the routine medical documentation
This retrospective study is designed to recall patient-related surgery-related factors as well as pathology reports including nodal staging from the medical databases The investigators aim to find correlation between methylene blue staining and lymph node yield In addition the investigators plan to crossmatch methylene blue injection as a process with long term survival of the patients
In order to reach this number of lymph nodes a precise surgical technique total mesorectal excision or complete mesocolic excision as well as a thorough pathological specimen work-up is needed
The aim of the study is to investigate if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist hence leading to a better staging and hopefully even to a better outcome in the long run
In 2014-2015 two surgical centers randomised resected colorectal specimens in 11 ratio to methylene-blue injection arm and control no injection arm in a total of 200 consecutive cases Both pathologic and oncologic treatment were led regardless of the injection reports were just routinely saved in the routine medical documentation
This retrospective study is designed to recall patient-related surgery-related factors as well as pathology reports including nodal staging from the medical databases The investigators aim to find correlation between methylene blue staining and lymph node yield In addition the investigators plan to crossmatch methylene blue injection as a process with long term survival of the patients
Detailed Description:
Background
Colorectal Cancer is the second most common cause of death in Hungary The most important prognostic and predictive factor of colorectal cancer is the stage of disease at the time of diagnosis Precise staging especially nodal staging is highly important for correct planning of oncotherapy ie adjuvant chemotherapy Nodal staging relies on the proper surgical removal of mesocolonmesorectum belonging to the the affected colorectal segment as well as on the thorough pathology work-up of the specimen
Current quality standards require examination of a minimum of 12 lymph nodes in order to reliably report N0 stage
Methylene-blue injection into the main supplying artery of the removed specimen is one of the simplest and most effective techniques described to aid pathologist in lymph node harvesting
Technique of methylene blue injection
First of all surgeon need to en block remove the affected colorectal segment with its mesecolonmesorectum Then the surgeon isolates the main supplying artery and cannulated it with an appropriate-size canula
Methylene blue solution 50 mg methylene blue diluted in in 30 ml saline is prepared and injected into the freshly removed specimen via the canula until the blue solution appears on the cut edges of the specimen
The specimen can be processed in a routine way placed in 4 formaldehyde
Aim of the study
The aim is to investigate if the well described and in Western-European healthcare systems well tested technique Methylene blue injection can be effectively adapted in an overwhelmed busy Eastern-European healthcare environment Other techniques including pathology assistant are not affordable in this area Apart form testing diagnostic accuracy of the pathologist on specimens with and without methylene blue injection the investigators would like to assess a potential survival benefit of the suspected improvement of staging effectivity
Timing of the study
Over a 20-month period of 2014 and 2015 two surgical centers in Hungary randomised their elective colorectal resection cases into interventional and control arms Randomisation was performed with a 11 ratio at each site on 100-100 consecutive cases
Further pathology work-up and reporting has been routinely performed without any specific effect on oncology follow-up or treatment No specific data collection has been performed after the intervention
This study aims to retrospectively select the 100-100 total of 200 consecutive colorectal resection cases of the given time frame from the official hospital medical recording systems
Pathology reports and other relevant patient clinical records will be collected and statistically assessed
Ethical approval was requested and gained from the Medical Research Council Hungary for the retrospective analysis of patient data
Statistical analysis
Power analysis was performed to get the sufficient number of cases 200 cases in total
Case Report Form The retrospectively included cases will be listed in a specific database on a safe medical server Anthropometric disease-specific operation-specific and pathology report details will be extracted out of the official patient documentation system
Patients will be included according to the known interventional interval and the operation type elective colorectal resection Cases in the database will be anonymized No patient-identifying data will be recorded or given to the assessor of the study statistician
Colorectal Cancer is the second most common cause of death in Hungary The most important prognostic and predictive factor of colorectal cancer is the stage of disease at the time of diagnosis Precise staging especially nodal staging is highly important for correct planning of oncotherapy ie adjuvant chemotherapy Nodal staging relies on the proper surgical removal of mesocolonmesorectum belonging to the the affected colorectal segment as well as on the thorough pathology work-up of the specimen
Current quality standards require examination of a minimum of 12 lymph nodes in order to reliably report N0 stage
Methylene-blue injection into the main supplying artery of the removed specimen is one of the simplest and most effective techniques described to aid pathologist in lymph node harvesting
Technique of methylene blue injection
First of all surgeon need to en block remove the affected colorectal segment with its mesecolonmesorectum Then the surgeon isolates the main supplying artery and cannulated it with an appropriate-size canula
Methylene blue solution 50 mg methylene blue diluted in in 30 ml saline is prepared and injected into the freshly removed specimen via the canula until the blue solution appears on the cut edges of the specimen
The specimen can be processed in a routine way placed in 4 formaldehyde
Aim of the study
The aim is to investigate if the well described and in Western-European healthcare systems well tested technique Methylene blue injection can be effectively adapted in an overwhelmed busy Eastern-European healthcare environment Other techniques including pathology assistant are not affordable in this area Apart form testing diagnostic accuracy of the pathologist on specimens with and without methylene blue injection the investigators would like to assess a potential survival benefit of the suspected improvement of staging effectivity
Timing of the study
Over a 20-month period of 2014 and 2015 two surgical centers in Hungary randomised their elective colorectal resection cases into interventional and control arms Randomisation was performed with a 11 ratio at each site on 100-100 consecutive cases
Further pathology work-up and reporting has been routinely performed without any specific effect on oncology follow-up or treatment No specific data collection has been performed after the intervention
This study aims to retrospectively select the 100-100 total of 200 consecutive colorectal resection cases of the given time frame from the official hospital medical recording systems
Pathology reports and other relevant patient clinical records will be collected and statistically assessed
Ethical approval was requested and gained from the Medical Research Council Hungary for the retrospective analysis of patient data
Statistical analysis
Power analysis was performed to get the sufficient number of cases 200 cases in total
Case Report Form The retrospectively included cases will be listed in a specific database on a safe medical server Anthropometric disease-specific operation-specific and pathology report details will be extracted out of the official patient documentation system
Patients will be included according to the known interventional interval and the operation type elective colorectal resection Cases in the database will be anonymized No patient-identifying data will be recorded or given to the assessor of the study statistician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None