Pituitary NeoplasmsPhase 4NCT02190994
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
A Phase 4 study testing Hydrocortisone and Prednisone in people with Pituitary Neoplasms and Craniopharyngiomas, run by West China Hospital at 1 site in China.
Trial summary
The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Neoplasms, Craniopharyngiomas
- What is being tested?
- Hydrocortisone and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18
- Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma)
Who cannot join
- Patients with pre-existing hyperthyroidism or Cushing's syndrome
- Patients with long-term glucocorticoids replacement history
- Patients with other co-morbidities that pose known influence upon the HPA-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)
- Patients with severe panhypopituitarism
- Patients with history of radiotherapy of the pituitary gland
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Senlin Yin, M.D., +86 13072808795, enforest@gmail.com
Shu Jiang, M.D.
About this study
The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). Surgical patients of our center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT) will be performed for assessment of the pituitary function at enrollment. Patients with normal pituitary function will be randomized into non-GC replacement group (group A) and low-dose GC replacement group (group B), while patients with impaired pituitary function will be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.
- Conditions
- Pituitary Neoplasms, Craniopharyngiomas
- Being tested
- Hydrocortisone, Prednisone
- Keywords
- Hydrocortisone, Pituitary adenomas, Replacement therapy
- Medical subject headings
- Pituitary Neoplasms, Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
used intravenously
PrednisoneDrug
used as tablet form
| Study group | Role | What they receive |
|---|---|---|
| A. Normal function, non-GC replacement | No intervention | No glucocorticoid replacement will be given perioperatively. |
| B. Normal function, low-dose GC | Active comparator | Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6; Receives: Drug: Hydrocortisone; Drug: Prednisone |
| C. Impaired function, low-dose GC | Active comparator | Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6; Receives: Drug: Hydrocortisone; Drug: Prednisone |
| D. Impaired function, high-dose GC | Active comparator | Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3. Receives: Drug: Hydrocortisone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plasma cortisol level
Plasma cortisol at 8:00, 16:00, 24:00 respectively
Measured: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline plasma ACTH level
ACTH at 8:00;
Measured: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline 24-hour urine free cortisol
24-hour urine free cortisol
Measured: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline insulin tolerance test result
insulin tolerance test result
Measured: 7, 30, 90 days post-op
Secondary outcomes (8)
Change from baseline plasma TSH level
plasma TSH level
Measured: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Sodium, potassium concentration in the blood and urine
Concentration of sodium, potassium in the blood and urine
Measured: Daily post-op,for the duration of hospital stay, an expected average of 7 days
Number of patients with postoperative infection
Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.
Measured: For the duration of hospital stay, an expected average of 7 days
Change from baseline health-related quality of life
The 15-Dimensions measure of health-related quality of life
Measured: 7, 30, 90 days post-op
Number of patients with recurred tumor
Enhanced MRI scan of the sellar region.
Measured: 3,6,12 months after surgery
Change from baseline plasma free T3 level
plasma free T3 level
Measured: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline plasma free T4 level
plasma free T4 level
Measured: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Urine output
24-hour urine output
Measured: Daily post-op,for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Jiang, West China Hospital
- Investigators
- Shu Jiang, M.D., Principal investigator, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190994
- Sponsor's protocol ID
- WestChina-2013137
- Status last verified
- Jul 2014
- First submitted
- 5 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
- ClinicalTrials.gov ID
- NCT02190994
- Acronym / sponsor ID
- WestChina-2013137
- Conditions
- Pituitary Neoplasms, Craniopharyngiomas
- Keywords
- Hydrocortisone, Pituitary adenomas, Replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). Surgical patients of our center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT) will be performed for assessment of the pituitary function at enrollment. Patients with normal pituitary function will be randomized into non-GC replacement group (group A) and low-dose GC replacement group (group B), while patients with impaired pituitary function will be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A. Normal function, non-GC replacement | No intervention | –No glucocorticoid replacement will be given perioperatively. |
| B. Normal function, low-dose GC | Active comparator | Drug: Hydrocortisone, Drug: PrednisoneHydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6; |
| C. Impaired function, low-dose GC | Active comparator | Drug: Hydrocortisone, Drug: PrednisoneHydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6; |
| D. Impaired function, high-dose GC | Active comparator | Drug: Hydrocortisone, Drug: PrednisoneHydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 18
- Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning pituitary adenoma or craniopharyngioma)
Key exclusion criteria (5 listed)
- Patients with pre-existing hyperthyroidism or Cushing's syndrome
- Patients with long-term glucocorticoids replacement history
- Patients with other co-morbidities that pose known influence upon the HPA-axis function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)
- Patients with severe panhypopituitarism
- Patients with history of radiotherapy of the pituitary gland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisoneused intravenously | Drug | B. Normal function, low-dose GC, C. Impaired function, low-dose GC, D. Impaired function, high-dose GC |
| Prednisoneused as tablet form | Drug | B. Normal function, low-dose GC, C. Impaired function, low-dose GC, D. Impaired function, high-dose GC |
Primary outcome
Change from baseline plasma cortisol level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Plasma cortisol at 8:00, 16:00, 24:00 respectively
Change from baseline plasma ACTH level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
ACTH at 8:00;
Change from baseline 24-hour urine free cortisol
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
24-hour urine free cortisol
Change from baseline insulin tolerance test result
Time frame: 7, 30, 90 days post-op
insulin tolerance test result
8 secondary outcomes
Change from baseline plasma TSH level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Sodium, potassium concentration in the blood and urine
Time frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
Number of patients with postoperative infection
Time frame: For the duration of hospital stay, an expected average of 7 days
Change from baseline health-related quality of life
Time frame: 7, 30, 90 days post-op
Number of patients with recurred tumor
Time frame: 3,6,12 months after surgery
Change from baseline plasma free T3 level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline plasma free T4 level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Urine output
Time frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu Jiang, M.D. principal investigator
West China Hospital, Sichuan University, Chengdu, Sichuan, PR China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and Prednisone in people with Pituitary Neoplasms and Craniopharyngiomas, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senlin Yin, M.D. (+86 13072808795, enforest@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline plasma cortisol level (time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.