UMIN-CTR Clinical Trial

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041513
Receipt No. 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 (Ver. 1)

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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
Email 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
Email aliangws@163.com

Sponsor
Institute Tianjin Medical University General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047391