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Transsphenoidal Extent of Resection Study (TRANSSPHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357498
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : November 25, 2019
Sponsor:
Collaborators:
John Wayne Cancer Institute
Swedish Medical Center
Northwestern University
Ohio State University
Washington University School of Medicine
University of Pittsburgh Medical Center
Information provided by (Responsible Party):
Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE February 6, 2015
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE February 1, 2015
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
percentage of patients who have complete tumor removal (gross total resection) based on MRI . [ Time Frame: 3 months post surgery ]
Postop MRI read by neuroradiologist
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
percentage of patients who have complete tumor removal (gross total resection) based on MRI . [ Time Frame: 3 months post surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • volume of residual tumor [ Time Frame: 3 months after date of surgery ]
    volume, analyzed as a continuous variable; will be determined by manual segmentation using Dominator (www.dominator.com) software under the supervision of a board-certified neuroradiologist
  • percentage of tumor removed [ Time Frame: 3 months post surgery ]
    Postop MRI tumor bed read by neuroradilogisy
  • postoperative cerebral-spinal fluid (CSF) leak [ Time Frame: 6 months (continuous) from surgery ]
    leakage from nose is a known complication, however, patients who have undergone a second surgery or had a lumbar drain placed to repair the problem will be documented
  • postoperative meningitis [ Time Frame: 6 months (continuous) from surgery ]
    Determined by symptoms of headache, fever, neck stiffness, nausea and vomiting, and occasionally an altered level of consciousness. CSF culture may be positive for infection and may show elevated glucose and/or protein. CSF may be negative in aseptic meningitis.
  • hypopituitarism [ Time Frame: 6 months post surgery ]
    (morning cortisol <4.0ug/dL)(adrenocorticotropic hormone ACTH <6.0pg/mL)(follicular stimulating hormone FSH - mIU/mL. Female: follicular: <3.5; midcycle <4.7; luteal <1.7; postmenopausal <25.8. male <1.7)(luteinizing hormone LH - mIU/mL. Female: follicular <2.4; midcycle <14.0; luteal <1.0; postmenopausal <7.7)(estradiol - pg/mL. female: follicular <13; ovulation <86; luteal <44; postmenopausal <56)(insulin-like growth factor 1 IGF1: 101ng/mL)(testosterone total - ng/dL. Female <6.0; male <270.0)(prolactin ,3.3ng/mL)(thyroid stimulating hormone TSH <.45mU/L)(Thyroxine T4 Free <0.8ng/dL
  • diabetes insipidus (DI) [ Time Frame: 6 months post surgery ]
    to be evaluated by pituitary endocrinologist; serum sodium value is > or equal to 147meq/dl OR if the patient received treatment for DI
  • visual outcomes [ Time Frame: 3 months post surgery ]
    visual field deficits in this exam will be compared to pre-operative results. Confrontation visual field exam (Donder's test): The examiner will ask the patient to cover one eye and stare at the examiner. The examiner will then move his hand out of the patient's visual field and bring it back in. The examiner will use a slowly wagging finger or a hat pin for this. The patient signals the examiner when his hand comes back into view. Second option is a formal visual field exam (perimetry) performed by a neuro-ophthalmologist.
  • hypothyroidism [ Time Frame: 6 months post surgery ]
    (thyroid stimulating hormone TSH <.45mU/L)(thyroxine T4Free <0.8ng/dL)
  • hypogonadism [ Time Frame: 6 months post surgery ]
    (Testosterone (Total) - ng/dL. Female: < 6.0; Male: < 270.0) (Follicular Stimulating Hormone (FSH) - mIU/mL. Female - Follicular: < 3.5; Midcycle: <4.7; Luteal: < 1.7; Postmenopausal: < 25.8. Male - < 1.5)(Luteinizing Hormone LH - mIU/mL. Female: Follicular: < 2.4; Midcycle: <14.0; Luteal: < 1.0; Postmenopausal: < 7.7. Male: < 1.7)(Estradiol - pg/mL. Female: Follicular: < 13; Ovulation: < 86; Luteal: < 44; Postmenopausal: < 56. Male: < 15)
  • growth hormone deficiency [ Time Frame: 6 months post surgery ]
    (insulin tolerance test: growth hormone <3μg/l)(IGF1 <77)(symptoms may include thin and dry skin, low energy, decreased strength and exercise tolerance, decreased muscle mass, weight gain especially around the waist, feelings of anxiety, depression, or sadness causing a change in social behavior
  • adrenal insufficiency [ Time Frame: 6 months post surgery ]
    (morning serum cortisol <4.0ug/dL)(ACTH <6.0pg/mL)(sodium <135mEq/L)(abnormal ACTH [cosyntropin] stimulation test)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • volume of residual tumor [ Time Frame: 3 months after date of surgery ]
    volume, analyzed as a continuous variable; will be determined by manual segmentation using Dominator (www.dominator.com) software under the supervision of a board-certified neuroradiologist
  • percentage of tumor removed [ Time Frame: 3 months post surgery ]
  • postoperative cerebral-spinal fluid (CSF) leak [ Time Frame: 6 months (continuous) from surgery ]
    leakage from nose is a known complication, however, patients who have undergone a second surgery or had a lumbar drain placed to repair the problem will be documented
  • postoperative meningitis [ Time Frame: 6 months (continuous) from surgery ]
    Determined by symptoms of headache, fever, neck stiffness, nausea and vomiting, and occasionally an altered level of consciousness. CSF culture may be positive for infection and may show elevated glucose and/or protein. CSF may be negative in aseptic meningitis.
  • hypopituitarism [ Time Frame: 6 months post surgery ]
    (morning cortisol <4.0ug/dL)(adrenocorticotropic hormone ACTH <6.0pg/mL)(follicular stimulating hormone FSH - mIU/mL. Female: follicular: <3.5; midcycle <4.7; luteal <1.7; postmenopausal <25.8. male <1.7)(luteinizing hormone LH - mIU/mL. Female: follicular <2.4; midcycle <14.0; luteal <1.0; postmenopausal <7.7)(estradiol - pg/mL. female: follicular <13; ovulation <86; luteal <44; postmenopausal <56)(insulin-like growth factor 1 IGF1: 101ng/mL)(testosterone total - ng/dL. Female <6.0; male <270.0)(prolactin ,3.3ng/mL)(thyroid stimulating hormone TSH <.45mU/L)(Thyroxine T4 Free <0.8ng/dL
  • diabetes insipidus (DI) [ Time Frame: 6 months post surgery ]
    to be evaluated by pituitary endocrinologist; serum sodium value is > or equal to 147meq/dl OR if the patient received treatment for DI
  • visual outcomes [ Time Frame: 3 months post surgery ]
    visual field deficits in this exam will be compared to pre-operative results. Confrontation visual field exam (Donder's test): The examiner will ask the patient to cover one eye and stare at the examiner. The examiner will then move his hand out of the patient's visual field and bring it back in. The examiner will use a slowly wagging finger or a hat pin for this. The patient signals the examiner when his hand comes back into view. Second option is a formal visual field exam (perimetry) performed by a neuro-ophthalmologist.
  • hypothyroidism [ Time Frame: 6 months post surgery ]
    (thyroid stimulating hormone TSH <.45mU/L)(thyroxine T4Free <0.8ng/dL)
  • hypogonadism [ Time Frame: 6 months post surgery ]
    (Testosterone (Total) - ng/dL. Female: < 6.0; Male: < 270.0) (Follicular Stimulating Hormone (FSH) - mIU/mL. Female - Follicular: < 3.5; Midcycle: <4.7; Luteal: < 1.7; Postmenopausal: < 25.8. Male - < 1.5)(Luteinizing Hormone LH - mIU/mL. Female: Follicular: < 2.4; Midcycle: <14.0; Luteal: < 1.0; Postmenopausal: < 7.7. Male: < 1.7)(Estradiol - pg/mL. Female: Follicular: < 13; Ovulation: < 86; Luteal: < 44; Postmenopausal: < 56. Male: < 15)
  • growth hormone deficiency [ Time Frame: 6 months post surgery ]
    (insulin tolerance test: growth hormone <3μg/l)(IGF1 <77)(symptoms may include thin and dry skin, low energy, decreased strength and exercise tolerance, decreased muscle mass, weight gain especially around the waist, feelings of anxiety, depression, or sadness causing a change in social behavior
  • adrenal insufficiency [ Time Frame: 6 months post surgery ]
    (morning serum cortisol <4.0ug/dL)(ACTH <6.0pg/mL)(sodium <135mEq/L)(abnormal ACTH [cosyntropin] stimulation test)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transsphenoidal Extent of Resection Study
Official Title  ICMJE Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas
Brief Summary The purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Another goal is to compare surgical complications, endocrine outcomes, visual outcomes, length of surgery, length of hospital stay, and readmission rates between the two transsphenoidal surgery techniques. This is an observational data collection study with no experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the two surgical techniques.
Detailed Description

The treatment of choice for most patients with symptomatic nonfunctioning pituitary adenomas is transsphenoidal surgery to improve vision by decompression of the optic chiasm, to prevent the development of endocrine dysfunction, and to treat neurological symptoms such as headache or cranial neuropathies caused by the tumor. The most widely accepted surgical technique is microscopic transsphenoidal surgery, in which an operating microscope is used by the surgeon to provide surgical visualization and a nasal speculum is used to maintain the operative corridor. [1-4] Recently, fully endoscopic transsphenoidal surgery, in which surgical visualization is achieved using an endoscope, has been adopted by many pituitary surgeons because the technique offers superior panoramic and angled visualization of the surgical target and may permit greater tumor resection. [5-10] There is a vigorous debate in the neurosurgical community about the relative merits of the microscopic and endoscopic techniques. Proponents of the endoscopic technique argue that the superior visualization permits more aggressive tumor resection and better preservation of the normal pituitary gland. Proponents of the microscopic technique argue that it permits shorter operative times, results in similar surgical outcomes, and has a lower complication rate.

Despite the adoption of fully endoscopic surgery by many surgeons, no prospective studies have compared the extent of tumor resection (EOR) between microscopic and endoscopic approaches. Numerous retrospective studies have established the efficacy of each approach, but only a few studies present comparative data.[11-13] Recently, McLaughlin et al. noted that the addition of endoscopy to microscopic pituitary surgery enhances tumor removal, particularly in patients with tumors greater than 20 mm in diameter. [14] This study raises the intriguing possibility that certain subgroups of patients (e.g. patients with larger tumors) may benefit from endoscopic surgery. In patients with smaller tumors with no cavernous sinus invasion, others have shown that the techniques achieve similar EOR. [15] That endoscopy may permit more complete tumor resections is a testable hypothesis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pituitary Adenoma
Intervention  ICMJE Procedure: transsphenoidal surgery
Study Arms  ICMJE
  • Active Comparator: microscopic
    Microscopic transsphenoidal surgery, including endoscopic-assisted approach (350 subjects)
    Intervention: Procedure: transsphenoidal surgery
  • Active Comparator: endoscopic
    Fully endoscopic transsphenoidal surgery (350 subjects)
    Intervention: Procedure: transsphenoidal surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2018)
260
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2015)
700
Actual Study Completion Date  ICMJE April 8, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery
  • Adults (age 18-80 years)
  • Medically stable for surgery
  • Reasonable expectation that patient will complete study and be available for follow-up assessments

Exclusion Criteria:

  • Prisoners
  • Pregnant women
  • Patients with suspected functioning pituitary adenoma
  • Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR)
  • Pituitary apoplexy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02357498
Other Study ID Numbers  ICMJE 14BN151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Collaborators  ICMJE
  • John Wayne Cancer Institute
  • Swedish Medical Center
  • Northwestern University
  • Ohio State University
  • Washington University School of Medicine
  • University of Pittsburgh Medical Center
Investigators  ICMJE
Principal Investigator: Andrew Little, MD Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP