CRISAL Study:Cancer Risk In Secreting Adrenal Lesions
NCT Number: NCT06520111
Acronym: CRISAL
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adrenal Tumor|Adrenal Incidentaloma|Surgery
Sponsor: University of Roma La Sapienza
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-27
Completion Date: 2024-11-10
Locations: General and Mininvasive Surgery Department, Pederzoli Hospital,, Peschiera del Garda, Verona, Italy., Italy

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.

Primary Outcome Measures: 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, From July to December 2024
Secondary Outcome Measures: 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)., From July to December 2024|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)., From July to December 2024|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)., From July to December 2024