CRISAL Study:Cancer Risk In Secreting Adrenal Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Roma La Sapienza
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective adrenalectomy;
Patients aged ≥ 18 years
Acceptance of informed consent
Disqualifiers
Patients aged ≤ 18 years
Pregnant patients
Trial population
This 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 (malignant/benign) in order to identify the incidence of cancer for each group, the results will then be compared within and postoperative at 30 days.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: patients underwent surgery for secreting adrenal lesion
Group B: patients underwent surgery for non- secreting adrenal lesion
Trial outcomes
Primary outcomes
1
Cancer risk in secreting adrenal lesions.
Number of patients who underwent adrenalectomy for secreting adrenal lesion which later proved to be malignant at definitive histological examination. This variable will be estimated as absolute and relative frequency and percentage value
Time frame
From July to December 2024Secondary outcomes
1
Cancer risk in secreting versus non-secreting adrenal lesions
Comparison between the incidence of cancer in patients affected by secreting adrenal lesions VS patients affected by non-secreting adrenal lesions. These two groups will be matched based on other preoperative characteristics (comorbidities and pharmacological therapies, cancer history, lesion size and site, preoperative imaging and hormonal evaluation) to reduce potential bias Categorical 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).
Time frame
From July to December 20242
Intraoperative and postoperative outcomes of patients undergoing adrenalectomy for secreting adrenal lesions versus non-secreting lesions
Comparison between intraoperative and 30-day postoperative outcomes of patients undergoing adrenalectomy for secreting adrenal lesions versus non-secretoring lesions. Categorical 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).
Time frame
From July to December 20243
Intraoperative and postoperative outcomes in different minimally invasive adrenalectomies
Comparison between the intraoperative and postoperative outcomes in different minimally invasive adrenalectomies (lateral, posterior, or anterior approach). Categorical 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).
Time frame
From July to December 2024Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Roma La Sapienza
Lead sponsor
IRCCS San Raffaele
Sponsor institution
Source ClinicalTrials.gov