Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial.

BACKGROUND: Cerebrospinal fluid (CSF) leakage is a frequent and challenging complication in neurosurgery, especially in the posterior fossa, with a prevalence of 8%. It is associated with substantial morbidity and increased healthcare costs. A novel dural sealant patch (LIQOSEAL) was developed for watertight dural closure. The objective of this study is to clinically assess the safety and effectiveness of LIQOSEAL as a means of reducing intra- as well as postoperative CSF leakage in patients undergoing elective posterior fossa intradural surgery with a dural closure procedure compared to the best currently available dural sealants. METHODS: We will conduct a two-arm, randomized controlled, multicenter study with a 90-day follow-up. A total of 228 patients will be enrolled in 19 sites, of which 114 will receive LIQOSEAL and 114 an FDA-approved PEG sealant. The composite primary endpoint is defined as intraoperative CSF leakage at PEEP 20 cm H2O, percutaneous CSF leakage within 90 days of, wound infection within 90 days of or pseudomeningocele of more than 20cc on MRI or requiring intervention. We hypothesize that the primary endpoint will not be reached by more than 10 patients (9%) in the investigational arm, which will demonstrate non-inferiority of LIQOSEAL compared to control. DISCUSSION: This trial will evaluate whether LIQOSEAL is non-inferior to control as a means of reducing CSF leakage and safety TRIAL REGISTRATION: ClinicalTrials.gov NCT04086550 . Registered on 11 September 2019.

Treatment of Nonfunctional Pituitary Adenoma Postoperative Remnants: Adjuvant or Delayed Gamma Knife Radiosurgery?

OBJECTIVE: It is still not clear whether Gamma Knife radiosurgery (GKRS) for nonfunctional pituitary adenomas should be used as a standard adjuvant postoperative therapy or applied when there is documented progression of the remnant on follow-up magnetic resonance imaging. METHODS: We performed a retrospective study of patients with nonfunctional pituitary adenomas who underwent primary surgery and GKRS between 2002 and 2015. Patients were divided into 2 groups on the basis of the GKRS indication: adjuvant treatment (GKRS ≤6 months postoperatively) or delayed treatment (GKRS if documented progression occurred on the follow-up magnetic resonance imaging). RESULTS: Fifty patients were included and grouped based on adjuvant (n = 13) or delayed (n = 37) GKRS following primary surgery. The adjuvant and delayed groups had 10-year actuarial tumor control rates of 92% and 96% (P = 0.408), respectively. The 10-year actuarial endocrinologic control rate was 82% for the adjuvant group and 49% for the delayed group (P = 0.597). None of the patients developed any new neurologic deficit post-GKRS. GKRS-induced complications (intratumoral bleeding and tumoral tissue inflammation) occurred in 6% of the patients, of whom 4% were in the delayed group and 2% in the adjuvant group. CONCLUSION: Adjuvant treatment with GKRS yields the same high long-term tumor control as delayed GKRS. Neither adjuvant nor delayed GKRS induced additional neurologic complications. There is a trend that adjuvant GKRS induces less additional endocrinologic deficits compared with delayed GKRS.