UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041513 |
|---|---|
| Receipt number | R000047391 |
| Scientific Title | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/08/21 22:37:10 |
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Basic information
Public title
A new perioperative glucocorticosteroid replacement therapy for cushing syndrome
Acronym
A perioperative glucocorticosteroid replacement therapy for cushing syndrome
Scientific Title
A new perioperative glucocorticosteroid replacement therapy for cushing syndrome
Scientific Title:Acronym
A perioperative glucocorticosteroid replacement therapy
Region
| Asia(except Japan) |
Condition
Condition
Perioperative
Classification by specialty
| Medicine in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safty and effects of a new perioperative glucocorticosteroid replacement therapy for Cushing,s syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adrenal insufficiency and steroid withdrawal syndrome were not occurred with all patients. Compared with the concentration of urine cortisol preoperation, it was significantly decreased on the day 7 postoperative. Plasma cortisol concentration was significantly decreased on the day 6 postoperative compared with preoperative. All the patients were followed up to 6 months,plasma cortisol and 24h urine cortisol levels were all normal.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hydrocortisone was given during adrenal resection by intravenous injectionon the surgical day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 61 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who accepted adrenal gland surgery were included in this study.
Key exclusion criteria
The patients who had unilateral or bilateral adrenal tumor or nodule but not accepted adrenal gland surgery were excluded in this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Liang |
| Middle name | |
| Last name | Wang |
Organization
Tianjin Medical University General Hospital
Division name
Deprtment of Urology
Zip code
300052
Address
NO 154, Anshan Road, He Ping District, Tianjin, China
TEL
+8615900209758
aliangws@163.com
Public contact
Name of contact person
| 1st name | Liang |
| Middle name | |
| Last name | Wang |
Organization
Tianjin Medical University General Hospital
Division name
Deprtment of Urology
Zip code
300052
Address
NO 154, Anshan Road, He Ping District, Tianjin, China
TEL
+8615900209758
Homepage URL
aliangws@163.com
Sponsor or person
Institute
Tianjin Medical University General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tianjin Medical University General Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tianjin Medical University General Hospital
Address
NO 154, Anshan Road, He Ping District, Tianjin, China
Tel
+8615900209758
aliangws@163.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
With all patients, the cortisol circadian rhythm disappeared; Low-dose dexamethasone suppression tes
Publication of results
Unpublished
Result
URL related to results and publications
ResMan Clinical Trial Management Public Platform
Number of participants that the trial has enrolled
83
Results
Adrenal insufficiency and steroid withdrawal syndrome were not occurred with all patients. Compared with the concentration of urine cortisol preoperation, it was significantly decreased on the day 7 postoperative. Plasma cortisol concentration was significantly decreased on the day 6 postoperative compared with preoperative. All the patients were followed up to 6 months,plasma cortisol and 24h urine cortisol levels were all normal.
Results date posted
| 2020 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age of these patients are ranged from 22 to 61 and the median age is 33. The course of disease is from 1.5 months to 51 months. Seventy eight patients were diagnosed as adrenal adenoma and 5 patients were diagnosed as ACTH independent macronodular adrenal hyperplasia. All the patients had different degree of centripetal obesity, moon face, sanguine temperament looks, skin purple striae and other typical signs of CS.
Participant flow
From July 2014 to July 2017, 83 CS patientswho were referred to our hospital for adrenal gland surgery were considered for this study. We reviewed the computerized database of the patients.
Adverse events
No
Outcome measures
All the patients had a successful operation. The symptoms of adrenal insufficiency includingweakness, fatigue, anorexia, weight loss, nausea and vomiting were not observed. Mortality was zero. Plasma cortisol and 24h urine cortisol levels were measured on the day 1, 2, 6, and 7 postoperative during hospitalization, respectively. Compared with preoperative, plasma cortisol levels on the day 1 and 2 postoperative slightly decreased but no statistical significance; Urine cortisol levels significantly rised (P < 0.05 ) respectively on the day 1 and 2 postoperative, and decreased on the day 6 postoperative to a level slightly lower than the levels of preoperative.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047391
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