Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale

Cervical Spondylotic Myelopathy Surgical Trial- Randomized, Controlled Trial Design and Rationale

Neurosurgery 75:334–346, 2014

Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.

OBJECTIVE: To determine whether ventral surgery is associated with superior Short Form- 36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.

METHODS: The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.

EXPECTED OUTCOMES: This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.

DISCUSSION: A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.

Endoscopic endonasal surgery for olfactory groove meningiomas: outcomes and limitations in 50 patients

Endoscopic endonasal surgery for olfactory groove meningiomas- outcomes and limitations in 50 patients

Neurosurg Focus 37 (4):E8, 2014

Recently, endoscopic endonasal surgery (EES) has been introduced in the management of skull base tumors, with constantly improving outcomes and increasing indications. The authors retrospectively reviewed the effectiveness of EES in the management of olfactory groove meningiomas.

Methods. Between February 2003 and December 2012, 50 patients (64% female) with olfactory groove meningiomas underwent EES at the University of Pittsburgh Medical Center. The authors present the results of EES and analyze the resection rates, clinical outcome, complications, and limitations of this approach.

Results. Forty-four patients presented with primary tumors, whereas six were previously treated elsewhere. The patients’ mean age was 57.1 years (range 27–88 years). Clinical presentation included altered mental status (36%), visual loss (30%), headache (24%), and seizures (20%). The mean maximum tumor diameter was 41.6 mm (range 18–80 mm). All patients underwent EES, which was performed in stages in 18 giant tumors. Complete tumor resection (Simpson Grade I) was achieved in 66.7% of the 45 patients in whom it was the goal, and 13 (28.9%) had neartotal resection (> 95% of the tumor). Tumor size, calcification, and absence of cortical cuff from vasculature were significant factors that influenced the degree of resection (p = 0.002, p = 0.024, and p = 0.028, respectively). Tumor residual was usually at the most lateral and anterior tumor margins. Following EES, mental status was improved or normalized in 77.8% of the cases, vision was improved or restored in 86.7%, and headaches resolved in 83.3%. There was no postoperative deterioration of presenting symptoms. Complications were increased in tumors > 40 mm and included CSF leakage (30%), which was significantly associated with lobular tumor configuration (p = 0.048); pulmonary embolism/deep vein thrombosis, more commonly in elderly patients (20%); sinus infections (10%); and delayed abscess months or years after EES (6%). One patient had an intraoperative vascular injury resulting in transient hemiparesis (2%). There were no perioperative deaths. During a mean follow-up period of 32 months (median 22 months, range 1–115 months), 1 patient underwent repeat EES for tumor regrowth.

Conclusions. Endoscopic endonasal surgery has shown good clinical outcomes regardless of patient age, previous treatment, or tumor characteristics. Tumor size > 40 mm, calcification, and absence of cortical vascular cuff limit GTR with EES; in addition, large tumors are associated with increased postoperative complications. Significant lateral and anterior dural involvement may represent indications for using traditional craniotomies for the management of these tumors. Postoperative CSF leakage remains a problem that necessitates innovations in EES reconstruction techniques.

Successful treatment of multiple intracranial meningiomas with the antiprogesterone receptor agent mifepristone (RU486)

RU486

Acta Neurochir (2014) 156:1831–1835

Meningiomas are the most frequent primary brain tumor in adults. Evidence suggests that female sex hormones play a role in the meningioma tumorigenesis. In particular, progesterone, has a receptor (PR) that is highly expressed in the majority of grade I meningiomas. Multiple meningiomas (diffuse meningiomatosis) are less frequent, but have a higher female predominance and a higher PR expression. They are, therefore, attractive candidates for anti-PR therapy.

Methods We treated three consecutive women with multiple meningiomas with mifepristone (RU 486). It is a synthetic steroid with high affinity for both progesterone and glucocorticoid receptors. Results The treatment was well tolerated, and we observed an important and long-lasting clinical (3/3) and radiological response (2/3) or stabilisation. All the three patients are now stable after five to nine years of treatment.

Conclusions These encouraging results strongly support a prospective clinical trial in this preselected population.