Skip to content

Randomized clinical trial to compare the results of pituitary macroadenoma surgery in intraoperative guidance vs conventional fluoroscopic guidance.

Randomized Two Arm Parallel Group Clinical trial to evaluate efficacy of trans-sphenoidal microscopic/endoscopic surgery using high field intra-operative magnetic resonance imaging guided resection as compared to two dimensional fluoroscopic guidance in extent of tumor resection in Pituitary macro-adenoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/07/003798
Enrollment
100
Registered
2013-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- A patient of pituitary macroadenoma usually suffers with endocrinological problems or with problems associated with mass effect of tumor on adjacent structures.

Interventions

Intervention1: MRI: MRI based neuronavigation Control Intervention1: Fluroscopy: Real time fluroscopy guidance

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pituitary macroadenoma 2.Size - From 1 cm to 4 cm 3.Proper consent available and willing for regular follow up till 3 months

Exclusion criteria

Exclusion criteria: 1.Age greater than or equal to 18 years 2.Microadenoma 3.Tumor size more than 4 cm in any dimension. 4.Involving two compartments or more. 5.Tumor reaching within 6mm of foramen of monro 6.Absolute Contraindication for trans-sphenoidal surgery â?? Acute Sphenoid sinusitis 7.Re-do surgery 8.Adjuvant Radiotherapy/ Gamma knife radiosurgery 9.Radiological or intra-operative evidence of extensive bone, duramater and sinuses involvement 10.Radiological evidence of > 50% encasement of ICA circumference 11.Histopathology report other than those categorised as pituitary adenomas

Design outcomes

Primary

MeasureTime frame
Percentage of tumor removed.Timepoint: Immediate post operative period

Secondary

MeasureTime frame
1. Residual /recurrent tumor 2. Assess and compare short term outcome in the two armsTimepoint: Three months.

Countries

India

Contacts

Public ContactDr Vivek Tandon

All India Institute of Medical Sciences

drtandonvivek@gmail.com9868398470

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026