title: Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.
abstract: Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications.
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India. Electronic address: drtandonvivek@gmail.com.
authors.forename: Vivek
authors.initials: V
authors.lastname: Tandon
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Amol
authors.initials: A
authors.lastname: Raheja
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Suri
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: P Sarat
authors.initials: PS
authors.lastname: Chandra
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Shashank S
authors.initials: SS
authors.lastname: Kale
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Rajinder
authors.initials: R
authors.lastname: Kumar
authors.affiliation: Department of Neuro-radiology, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Ajay
authors.initials: A
authors.lastname: Garg
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Mani
authors.initials: M
authors.lastname: Kalaivani
authors.affiliation: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Ravindra M
authors.initials: RM
authors.lastname: Pandey
authors.affiliation: Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi 110029, India.
authors.forename: Bhawani S
authors.initials: BS
authors.lastname: Sharma
mesh_terms: D000328:Adult; D004724:Endoscopy / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects* / Q000379:methods; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000009:adverse effects* / Q000379:methods; D010911:Pituitary Neoplasms / Q000601:surgery*; D011183:Postoperative Complications; D025321:Surgery, Computer-Assisted / Q000009:adverse effects* / Q000379:methods
keywords: Fluoroscopy; Intraoperative magnetic resonance imaging; Pituitary adenoma; Prospective randomized clinical trial