Endocrine Outcome of Surgery for Pituitary Adenoma

May 14, 2023 updated by: Andrej Pala, University of Ulm

Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Günzburg, Germany, 89312
        • Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endocrine function
Time Frame: 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.
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of resection
Time Frame: 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
tumor volume before the surgery, 3 months after surgery
Quality of Life, EQ-5D
Time Frame: 3 months and 1 year after surgery
EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.
3 months and 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 14, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndOSPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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