Pituitary AdenomaNCT06156020
Outcome Analysis of Endoscopic Resection of Pituitary Adenomas
A study testing Endoscopic endonasal surgery in people with Pituitary Adenoma, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection. The main question it aims to answer is: What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Endoscopic endonasal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Pathological diagnosis of pituitary adenoma
- Underwent endoscopic endonasal resection
Who cannot join
- Age < 18 or > 80 years
- Non-pituitary adenoma pathologies
- Underwent non-endoscopic surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Jung-Shun Lee
About this study
Official title: Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas
The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection.
The main question it aims to answer is:
- What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes.
Participants' data including clinical history, laboratory data, radiographic images, intraoperative videos will be evaluated and analyzed.
- Conditions
- Pituitary Adenoma
- Being tested
- Endoscopic endonasal surgery
- Keywords
- pituitary adenoma
- 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 endonasal surgeryProcedure or surgery
Endoscopic endonasal transsphenoidal approach for resection of pituitary adenomas
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic endonasal surgery | Other | Patients who received endoscopic endonasal resection of pituitary adenomas Receives: Procedure: Endoscopic endonasal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field
The postoperative visual field will be assessed with standard visual perimetry and compared with preoperative measurements.
Measured: 6 months
Diabetes insipidus
Postoperatively, the patient's urine output and urine specific gravity will be measured to determine if the patient had diabetes insipidus. If the patient had diabetes insipidus, the duration of the diabetes insipidus will be recorded.
Measured: 6 months
Cortisol level
Postoperative serum cortisol level will be measured and compared to preoperative levels.
Measured: 6 months
Thyroid hormone level
Postoperative serum TSH and free T4 level will be measured and compared to preoperative levels.
Measured: 6 months
Prolactin level
Postoperative serum prolactin level will be measured and compared to preoperative levels.
Measured: 6 months
IGF-1 level
Postoperative serum IGF-1 level will be measured and compared to preoperative levels.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jan 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156020
- Sponsor's protocol ID
- B-ER-112-452
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong CE, Chen PW, Hsu HJ, Cheng SY, Fan CC, Chen YC, Chiu YP, Lee JS, Liang SF. Collaborative Human-Computer Vision Operative Video Analysis Algorithm for Analyzing Surgical Fluency and Surgical Interruptions in Endonasal Endoscopic Pituitary Surgery: Cohort Study. J Med Internet Res. 2024 Jul 4;26:e56127. doi: 10.2196/56127.
PubMed 38963694
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT06156020
- Acronym / sponsor ID
- B-ER-112-452
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary adenoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Dec 2023 (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.
The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection.
The main question it aims to answer is:
- What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes.
Participants' data including clinical history, laboratory data, radiographic images, intraoperative videos will be evaluated and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic endonasal surgery | Other | Procedure: Endoscopic endonasal surgeryPatients who received endoscopic endonasal resection of pituitary adenomas |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- Pathological diagnosis of pituitary adenoma
- Underwent endoscopic endonasal resection
Key exclusion criteria (3 listed)
- Age < 18 or > 80 years
- Non-pituitary adenoma pathologies
- Underwent non-endoscopic surgery
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 endonasal surgeryEndoscopic endonasal transsphenoidal approach for resection of pituitary adenomas | Procedure or surgery | Endoscopic endonasal surgery |
Primary outcome
Visual field
Time frame: 6 months
The postoperative visual field will be assessed with standard visual perimetry and compared with preoperative measurements.
Diabetes insipidus
Time frame: 6 months
Postoperatively, the patient's urine output and urine specific gravity will be measured to determine if the patient had diabetes insipidus. If the patient had diabetes insipidus, the duration of the diabetes insipidus will be recorded.
Cortisol level
Time frame: 6 months
Postoperative serum cortisol level will be measured and compared to preoperative levels.
Thyroid hormone level
Time frame: 6 months
Postoperative serum TSH and free T4 level will be measured and compared to preoperative levels.
Prolactin level
Time frame: 6 months
Postoperative serum prolactin level will be measured and compared to preoperative levels.
IGF-1 level
Time frame: 6 months
Postoperative serum IGF-1 level will be measured and compared to preoperative levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 38963694Wong CE, Chen PW, Hsu HJ, Cheng SY, Fan CC, Chen YC, Chiu YP, Lee JS, Liang SF. Collaborative Human-Computer Vision Operative Video Analysis Algorithm for Analyzing Surgical Fluency and Surgical Interruptions in Endonasal Endoscopic Pituitary Surgery: Cohort Study. J Med Internet Res. 2024 Jul 4;26:e56127. doi: 10.2196/56127.
- Individual participant dataSharing planned: No
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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.
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 endonasal surgery in people with Pituitary Adenoma, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Shun Lee, MD (+886-6-2353535 ext. 5291, nslee1218@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field (time frame: 6 months). The study lists 6 primary outcomes in all. 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 NCT06156020, 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 21 Mar 2024.