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Trial registered on ANZCTR


Registration number
ACTRN12608000567325
Ethics application status
Approved
Date submitted
28/10/2008
Date registered
12/11/2008
Date last updated
12/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of subclinical Cushing's syndrome in adrenal incidentalomas
Scientific title
Surgical versus conservative management for subclinical Cushing's syndrome in adrenal incidentalomas.
Universal Trial Number (UTN)
Trial acronym
No acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subclinical Cushing's syndrome in adrenal incidentalomas 3951 0
Condition category
Condition code
Metabolic and Endocrine 4092 4092 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic adrenal surgery. This involves the removal of the adrenal gland by laparoscopic instruments via a transperitoneal lateral approach. This is the only surgical procedure we perform in this trial
Intervention code [1] 3619 0
Treatment: Surgery
Comparator / control treatment
The participants in the control group have subclinical Cushing's syndrome in adrenal incidentalomas and they continue to receive conservative treatment for this condition. At the entry in the study, all patients in the conservarive group are in medical treatment that is different for each clinical disease. Patients with subclinical Cushing's syndrome presenting diabetes mellitus are in antidiabetic medication (oral antidiabetic medication or insulin) and they continue to have their therapy; patients with subclinical Cushing's syndrome presenting arterial hypertension are in antihypertensive treatment and they continue to have their therapy;patients with subclinical Cushing's syndrome presenting hypertriglyceridemia are in statin therapy and they continue to have their therapy. The study will continue enough to have a mean follow-up of 7 years for each enrolled patient.
Control group
Active

Outcomes
Primary outcome [1] 4987 0
Clinical outcome of subclinical Cushing's syndrome patients who underwent adrenalectomy versus those managed conservatively measured with laboratory test and clinical parameters.
Diabetes mellitus is measured with plasma concentration of fasting glucose (normal, < 110 mg/dL); arterial hypertension with systolic and diastolic values of blood pressure (normal, systolic < 150 mmHg; diastolic < 90 mmHg); obesity with body mass index (BMI) calculated as weight in kilograms divided per height in meter squared; osteoporosis by measuring the bone mineral density (BMD), i.e. the amount of calcium in bone regions, evaluated by dual energy x-ray absorptiometry (DEXA).
Timepoint [1] 4987 0
All participants in the surgical group are assessed 6 and 12 months after surgery and then yearly by two experienced endocrinologists to monitor any improvements in clinical symptoms, laboratory findings and comorbidities.
All participants in the control group are assessed yearly during the follow-up period by two experienced endocrinologists to monitor any improvements in clinical symptoms, laboratory findings and comorbidities.
The study will continue enough to have a mean follow-up of 7 years for each enrolled patient.
Secondary outcome [1] 8420 0
Perioperative death
Timepoint [1] 8420 0
Death within 30 days after surgery

Eligibility
Key inclusion criteria
No clinical signs of cortisol excess and failure to suppress serum cortisol using the dexamathasone test
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adrenal mass > 3.5 cm in diameter

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were assigned to surgical or observation by sequentially following a list of randomly generated binary digits by a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1308 0
Italy
State/province [1] 1308 0
Country [2] 1309 0
Italy
State/province [2] 1309 0
Padova

Funding & Sponsors
Funding source category [1] 4128 0
Self funded/Unfunded
Name [1] 4128 0
Antonio Toniato, MD
Address [1] 4128 0
Via N. Giustiniani, 2
Padova
Country [1] 4128 0
Italy
Primary sponsor type
Individual
Name
Antonio Toniato, M.D.
Address
Via N. Giustiniani, 2
Padova
Country
Italy
Secondary sponsor category [1] 3714 0
None
Name [1] 3714 0
Address [1] 3714 0
Country [1] 3714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6157 0
Ethics Committee of the University of Padua, School of Medicine
Ethics committee address [1] 6157 0
Via N. Giustiniani,2
Padova
Ethics committee country [1] 6157 0
Italy
Date submitted for ethics approval [1] 6157 0
Approval date [1] 6157 0
12/02/1991
Ethics approval number [1] 6157 0
91/562

Summary
Brief summary
We compared the clinical outcome of patients with subclinical Cushing’s syndrome due to an adrenal incidentaloma randomly assigned to undergo surgery (n = 23) or close follow-up (n = 22). Laparoscopic adrenalectomy was more beneficial than conservative management for subclinical Cushing’s syndrome patients complying with our selection criteria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29077 0
Address 29077 0
Country 29077 0
Phone 29077 0
Fax 29077 0
Email 29077 0
Contact person for public queries
Name 12234 0
Antonio Toniato, M.D.
Address 12234 0
Via N. Giustiniani,2
Padova
Country 12234 0
Italy
Phone 12234 0
39.049.8212258
Fax 12234 0
Email 12234 0
giorgiolina@libero.it
Contact person for scientific queries
Name 3162 0
Antonio Toniato, M.D.
Address 3162 0
Via N. Giustiniani,2
Padova
Country 3162 0
Italy
Phone 3162 0
39.049.8212258
Fax 3162 0
Email 3162 0
giorgiolina@libero.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary