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Endocrine Outcome of Surgery for Pituitary Adenoma

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ClinicalTrials.gov Identifier: NCT03515603
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Andrej Pala, University of Ulm

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Quality of Life [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515603


Contacts
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Contact: Andrej Pala, MD +4982219628866 andrej.pala@uni-ulm.de
Contact: Michal Hlavac, MD michal.hlavac@uni-ulm.de

Locations
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Germany
Department of Neurosurgery Recruiting
Günzburg, Germany, 89312
Contact: Monika Deininger    +4982219622504    monika.deininger@bkh-guenzburg.de   
Contact: Andrej Pala, MD       andrej.pala@uni-ulm.de   
Principal Investigator: Andrej Pala, MD         
Principal Investigator: Michal Hlavac, MD         
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Andrej Pala, MD University Ulm, Department of Neurosurgery

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Responsible Party: Andrej Pala, Principal Investigator, University of Ulm
ClinicalTrials.gov Identifier: NCT03515603     History of Changes
Other Study ID Numbers: EndOSPA
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Adenoma
Pituitary Neoplasms
Pituitary Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms