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Transsphenoidal Extent of Resection Study (TRANSSPHER)

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ClinicalTrials.gov Identifier: NCT02357498
Recruitment Status : Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
John Wayne Cancer Institute
Swedish Medical Center
Northwestern University
Ohio State University
Washington University School of Medicine
University of Pittsburgh
Information provided by (Responsible Party):
Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix

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.

Condition or disease Intervention/treatment Phase
Pituitary Adenoma Procedure: transsphenoidal surgery Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas
Actual Study Start Date : February 1, 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: microscopic
Microscopic transsphenoidal surgery, including endoscopic-assisted approach (350 subjects)
Procedure: transsphenoidal surgery
Active Comparator: endoscopic
Fully endoscopic transsphenoidal surgery (350 subjects)
Procedure: transsphenoidal surgery



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. percentage of tumor removed [ Time Frame: 3 months post surgery ]
    Postop MRI tumor bed read by neuroradilogisy

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. hypothyroidism [ Time Frame: 6 months post surgery ]
    (thyroid stimulating hormone TSH <.45mU/L)(thyroxine T4Free <0.8ng/dL)

  9. 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)

  10. 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

  11. 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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357498


Locations
United States, Arizona
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
John Wayne Cancer Institute
Swedish Medical Center
Northwestern University
Ohio State University
Washington University School of Medicine
University of Pittsburgh
Investigators
Principal Investigator: Andrew Little, MD Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

Publications:

Responsible Party: Pam Dewey, Clinical Research Operations Manager, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02357498     History of Changes
Other Study ID Numbers: 14BN151
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix:
pituitary
adenoma
transsphenoidal surgery

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases