Endocrine Outcome of Surgery for Pituitary Adenoma

NCT03515603 | Terminated

• 1 other identifier: EndOSPA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• endocrine function

  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 Outcomes (2)

• Extent of resection

  tumor volume before the surgery, 3 months after surgery

• Quality of Life, EQ-5D

  3 months and 1 year after surgery

Study Arms (2)

microsurgical technique

ACTIVE COMPARATOR

Procedure: Microsurgical resection

endoscopic technique

ACTIVE COMPARATOR

Procedure: Endoscopic resection

Interventions

Endoscopic resection PROCEDURE

Transsphenoidal endoscopic resection of pituitary adenoma

endoscopic technique

Microsurgical resection PROCEDURE

Transsphenoidal microsurgical resection of pituitary adenoma

microsurgical technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected symptomatic or progressively growing pituitary adenoma
• Informed consent

You may not qualify if:

• Prolactinoma
• No follow-up possible
• Emergency surgery without informed consent or without intraoperative MRI

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Department of Neurosurgery

Günzburg, 89312, Germany

Location

Related Publications (1)

• Pala A, Grubel N, Mayer B, Becker R, Sommer F, Schmitz B, Etzrodt-Walter G, Wirtz CR, Hlavac M. Endocrine Outcome and Quality of Life After Transsphenoidal Resection of Pituitary Adenoma-A Prospective Randomized Single-Blinded Study Comparing Endoscopic Versus Microscopic Resection. Neurol Int. 2025 Jan 10;17(1):5. doi: 10.3390/neurolint17010005.

  PMID: 39852769 DERIVED

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Andrej Pala, MD

  University Ulm, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective randomized

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: May 3, 2018
• Study Start: May 10, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

DE (1)