Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520111
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
CRISAL StudyCancer Risk In Secreting Adrenal Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CRISAL StudyCancer Risk In Secreting Adrenal Lesions
Status:
RECRUITING
Status Verified Date:
2024-08
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:
CRISAL
Brief Summary:
The aim of the present study is to report the cancer risk in secreting adrenal lesions Secondary aims to compare the incidence of cancer in secreting versus non-secreting adrenal lesions in order to evaluate whether adrenal hormone activity can be considered an independent predictive indicator of malignancy compare intraoperative and 30-day postoperative outcomes of patients undergoing adrenalectomy for secreting adrenal lesions versus non-secretoring lesions regardless of the type of adrenal lesion identify if there is one MIS adrenal approach that is superior to the others in terms of intra- and postoperative outcomes
Detailed Description:
Background The risk of adrenal cancer increases with increasing lesion size Up to 60 of malignant adrenal lesions have hormonal activity and that hypercortisolism is strongly suggestive of malignancy however data regarding the risk of cancer risk in secreting adrenal lesions are not indicated
Although guidelines suggest open adrenalectomy for lesions with preoperative features suspicious of malignancy size 6 cm radiological features suggestive of malignancy history of neoplastic disease rapid growth several authors have reported the safety and feasibility of minimally invasive surgery MIS also in these cases
Since no clear superiority of one MIS approach over another lateral posterior or anterior approach in terms of perioperative outcomes has been demonstrated the guidelines agree on using the more familiar approach to the surgeon
Knowing the oncological risk of adrenal secretion lesions could allow greater awareness in the patients multidisciplinary approach and a better balance of the risk-benefit ratio in the choice of management of the patient affected by secreting adrenal lesion especially in the case of asymptomatic lesion or manageable with medical therapy Comparison of the various surgical approaches for the different types of adrenal lesions could allow identifying the best surgical route for each of them
Methods This study will be conducted in accordance with the principles of the Declaration of Helsinki and the guidelines for good clinical practice ICHGCP The study protocol will be approved by the Ethics Committee of the institutions involved An Institutional Data Safety Monitoring Board will also be appointedThis is an ambispective retrospective and prospective multicentre observational study It will based on the consecutive enrollment of all patients aged 18 years or over undergoing elective adrenalectomy after the acceptance of informed consent For the primary aim of the study only patients affected by secreting adrenal lesion will be considered and the incidence of cancer will be established on the basis of the definitive histology For the further aims of the study all enrolled patients will be divided into patients with secreting adrenal lesions and patients with non-secreting adrenal lesions Both groups will be stratified on the basis of definitive histology malignantbenign in order to identify the incidence of cancer for each group the results will then be compared within and postoperative at 30 days To assess the superiority of one approach over another all patients will be stratified according to the minimally invasive approach adopted anterior transperitoneal lateral transperitoneal lateral retroperitoneal prone retroperitoneal laparoscopic robotic and the type of adrenal pathology secretory lesion malignant tumor metastasis pheochromocytoma etc and will be compared in terms of intra and 30 days postoperative results All patients undergoing elective adrenalectomy aged 18 years will be included in the present study Emergency cases and pregnant patients will be excluded
The study involves the collection of the following data through the Redcap platform patient demographic data preoperative data comorbidities and pharmacological therapies previous abdominal surgery cancer history lesion size and site preoperative imaging and hormonal evaluation American Society of Anaesthesiologists ASA class Charlson comorbidity index CCI score intraoperative data surgical technique and surgical approach trocar number position and size in case of minimally invasive surgery type of incision in case of open surgery intraoperative complications associated surgical procedures conversion rate operative time intraoperative blood transfusions and postoperative data complications according to the Clavien-Dindo classification re-intervention rate postoperative stay 30-day hospital readmission rate 30 days-mortality definitive histological examination oncological results at follow up participating center number of adrenalectomies by year number of adrenalectomies per year performed by the operator
Statistic analysisA formal determination of the sample size was not carried out due to the ambispective observational nature of the study cohort and due to the absence in the literature of a common agreement on the incidence of cancer in patients with adrenal secreting lesions Based on the case-series available from the SICE Società Italiana di Chirurgia Endoscopica a total recruitment capacity is estimated summation of the number of patients per year per participating center of about 300 patientsCategorical variables will be estimated as absolute and relative frequency while continuous variables as median IQR interquartile range Inferential statistics for categorical variables will be estimated by Fisher exact test while those of continuous variables by Mann-Whitney and Kruskal-Wallis tests for independent data and Wilcoxon and Friedman tests for repeated data
Institutional Review Boards Authorship and publication The rules described here apply to any presentation of this study Members of the scientific committee qualify for the authorship of this study Up to three authors per participating center can be entered into group authorship which will be fully citable The order of authors in the authorship group will be based on their active contribution to the study Study results may be published andor presented as final analyzes only after study completion Publication andor presentation means any paper podium presentation poster abstract or any other public presentation of this research Data of each patient will be collected autonomously and anonymously by the single centers involved using a common alphanumeric code decided by the coordinating centre The collection of the aforementioned data will take place only after acceptance of the informed consent by the patient in accordance with the Declaration of Helsinki and after approval by the Ethics Committee of the proposing centre
Although guidelines suggest open adrenalectomy for lesions with preoperative features suspicious of malignancy size 6 cm radiological features suggestive of malignancy history of neoplastic disease rapid growth several authors have reported the safety and feasibility of minimally invasive surgery MIS also in these cases
Since no clear superiority of one MIS approach over another lateral posterior or anterior approach in terms of perioperative outcomes has been demonstrated the guidelines agree on using the more familiar approach to the surgeon
Knowing the oncological risk of adrenal secretion lesions could allow greater awareness in the patients multidisciplinary approach and a better balance of the risk-benefit ratio in the choice of management of the patient affected by secreting adrenal lesion especially in the case of asymptomatic lesion or manageable with medical therapy Comparison of the various surgical approaches for the different types of adrenal lesions could allow identifying the best surgical route for each of them
Methods This study will be conducted in accordance with the principles of the Declaration of Helsinki and the guidelines for good clinical practice ICHGCP The study protocol will be approved by the Ethics Committee of the institutions involved An Institutional Data Safety Monitoring Board will also be appointedThis is an ambispective retrospective and prospective multicentre observational study It will based on the consecutive enrollment of all patients aged 18 years or over undergoing elective adrenalectomy after the acceptance of informed consent For the primary aim of the study only patients affected by secreting adrenal lesion will be considered and the incidence of cancer will be established on the basis of the definitive histology For the further aims of the study all enrolled patients will be divided into patients with secreting adrenal lesions and patients with non-secreting adrenal lesions Both groups will be stratified on the basis of definitive histology malignantbenign in order to identify the incidence of cancer for each group the results will then be compared within and postoperative at 30 days To assess the superiority of one approach over another all patients will be stratified according to the minimally invasive approach adopted anterior transperitoneal lateral transperitoneal lateral retroperitoneal prone retroperitoneal laparoscopic robotic and the type of adrenal pathology secretory lesion malignant tumor metastasis pheochromocytoma etc and will be compared in terms of intra and 30 days postoperative results All patients undergoing elective adrenalectomy aged 18 years will be included in the present study Emergency cases and pregnant patients will be excluded
The study involves the collection of the following data through the Redcap platform patient demographic data preoperative data comorbidities and pharmacological therapies previous abdominal surgery cancer history lesion size and site preoperative imaging and hormonal evaluation American Society of Anaesthesiologists ASA class Charlson comorbidity index CCI score intraoperative data surgical technique and surgical approach trocar number position and size in case of minimally invasive surgery type of incision in case of open surgery intraoperative complications associated surgical procedures conversion rate operative time intraoperative blood transfusions and postoperative data complications according to the Clavien-Dindo classification re-intervention rate postoperative stay 30-day hospital readmission rate 30 days-mortality definitive histological examination oncological results at follow up participating center number of adrenalectomies by year number of adrenalectomies per year performed by the operator
Statistic analysisA formal determination of the sample size was not carried out due to the ambispective observational nature of the study cohort and due to the absence in the literature of a common agreement on the incidence of cancer in patients with adrenal secreting lesions Based on the case-series available from the SICE Società Italiana di Chirurgia Endoscopica a total recruitment capacity is estimated summation of the number of patients per year per participating center of about 300 patientsCategorical variables will be estimated as absolute and relative frequency while continuous variables as median IQR interquartile range Inferential statistics for categorical variables will be estimated by Fisher exact test while those of continuous variables by Mann-Whitney and Kruskal-Wallis tests for independent data and Wilcoxon and Friedman tests for repeated data
Institutional Review Boards Authorship and publication The rules described here apply to any presentation of this study Members of the scientific committee qualify for the authorship of this study Up to three authors per participating center can be entered into group authorship which will be fully citable The order of authors in the authorship group will be based on their active contribution to the study Study results may be published andor presented as final analyzes only after study completion Publication andor presentation means any paper podium presentation poster abstract or any other public presentation of this research Data of each patient will be collected autonomously and anonymously by the single centers involved using a common alphanumeric code decided by the coordinating centre The collection of the aforementioned data will take place only after acceptance of the informed consent by the patient in accordance with the Declaration of Helsinki and after approval by the Ethics Committee of the proposing centre
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