Pituitary AdenomaNCT03515603
Endocrine Outcome of Surgery for Pituitary Adenoma
A study testing Endoscopic resection and Microsurgical resection in people with Pituitary Adenoma, run by University of Ulm at 1 site in Germany.
Trial summary
Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Endoscopic resection and Microsurgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected symptomatic or progressively growing pituitary adenoma
- Informed consent
Who cannot join
- Prolactinoma
- No follow-up possible
- Emergency surgery without informed consent or without intraoperative MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pituitary Adenoma
- Being tested
- Endoscopic resection, Microsurgical resection
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
Transsphenoidal endoscopic resection of pituitary adenoma
Microsurgical resectionProcedure or surgery
Transsphenoidal microsurgical resection of pituitary adenoma
| Study group | Role | What they receive |
|---|---|---|
| microsurgical technique | Active comparator | Not described Receives: Procedure: Microsurgical resection |
| endoscopic technique | Active comparator | Not described Receives: Procedure: Endoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after surgery
Secondary outcomes (2)
Extent of resection
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
Measured: tumor volume before the surgery, 3 months after surgery
Quality of Life, EQ-5D
EQ-5D will be evaluated before surgery, after the surgery in 3 months and after 1 year.
Measured: 3 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start10 May 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Inadequate recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Pala, University of Ulm
- Investigators
- Andrej Pala, MD, Principal investigator, University Ulm, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515603
- Sponsor's protocol ID
- EndOSPA
- Status last verified
- May 2023
- First submitted
- 14 Apr 2018
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39852769
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI
- ClinicalTrials.gov ID
- NCT03515603
- Acronym / sponsor ID
- EndOSPA
- Conditions
- Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- prospective randomized
| Arm | Type | Receives |
|---|---|---|
| microsurgical technique | Active comparator | Procedure: Microsurgical resection |
| endoscopic technique | Active comparator | Procedure: Endoscopic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected symptomatic or progressively growing pituitary adenoma
- Informed consent
Key exclusion criteria (3 listed)
- Prolactinoma
- No follow-up possible
- Emergency surgery without informed consent or without intraoperative MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic resectionTranssphenoidal endoscopic resection of pituitary adenoma | Procedure or surgery | endoscopic technique |
| Microsurgical resectionTranssphenoidal microsurgical resection of pituitary adenoma | Procedure or surgery | microsurgical technique |
Primary outcome
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.
2 secondary outcomes
Extent of resection
Time frame: tumor volume before the surgery, 3 months after surgery
Quality of Life, EQ-5D
Time frame: 3 months and 1 year after surgery
Results and safety
The study was stopped early (reason given: Inadequate recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 39852769Pala 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Pala, MD principal investigator
University Ulm, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic resection and Microsurgical resection in people with Pituitary Adenoma, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endocrine function (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.