Endocrine Outcome of Surgery for Pituitary Adenoma

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03515603

Enrollment

Registered

2018-05-03

Start date

2018-05-10

Completion date

2022-12-31

Last updated

2023-05-17

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

Conditions

Pituitary Adenoma

Brief summary

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

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.

Interventions

PROCEDUREMicrosurgical resection

Transsphenoidal microsurgical resection of pituitary adenoma

PROCEDUREEndoscopic resection

Transsphenoidal endoscopic resection of pituitary adenoma

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded

Intervention model description

prospective randomized

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026