Endocrine Outcome of Surgery for Pituitary Adenoma

• Sponsor: University of Ulm (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03515603
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Adenoma	Procedure: Endoscopic resection; Procedure: Microsurgical resection	N/A

Detailed Description

The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective randomizedprospective randomized
• Masking: Double (Participant, Care Provider)
• Masking Description: only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded
• Primary Purpose: Treatment
• Official Title: Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI
• Actual Study Start Date: May 10, 2018
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: microsurgical technique	Procedure: Microsurgical resection; Transsphenoidal microsurgical resection of pituitary adenoma
Active Comparator: endoscopic technique	Procedure: Endoscopic resection; Transsphenoidal endoscopic resection of pituitary adenoma

Outcome Measures

Primary Outcome Measures

1. endocrine function [1 year after surgery]

   Testing of pituitary function with insulin-hypoglycemic test, results will be dichotomized as satisfactory or not satisfactory. Satisfactory outcome is defined, if pituitary function improves or is stable, if compared to preoperative testing.

Secondary Outcome Measures

1. Extent of resection [tumor volume before the surgery, 3 months after surgery]

   Volumetric analysis of tumor volume before the surgery, intraoperatively and 3 months after surgery will be performed. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences

2. Quality of Life, EQ-5D [3 months and 1 year after surgery]

   EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Suspected symptomatic or progressively growing pituitary adenoma

• Informed consent

Exclusion Criteria:

• Prolactinoma

• No follow-up possible

• Emergency surgery without informed consent or without intraoperative MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery	Günzburg		Germany	89312

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Andrej Pala, MD, University Ulm, Department of Neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrej Pala, Principal Investigator, University of Ulm
• ClinicalTrials.gov Identifier: NCT03515603
• Other Study ID Numbers: EndOSPA
• First Posted: May 3, 2018
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases

Study Results

No Results Posted as of Nov 27, 2020