SurgeryNCT05448690
Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
A study testing Two different approaches and Non-combined approach in people with Surgery and Pituitary Adenoma, run by Huashan Hospital at 13 sites in China.
Trial summary
The surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options. Read more about this study
- Who is it for?
- Ages 6 to 85 years
- Conditions the study is for
- Surgery, Pituitary Adenoma
- What is being tested?
- Two different approaches and Non-combined approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 13 sitesChina
- Study dates
- 1 Jan 2022to 1 Jan 2023
- 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 6 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Giant pituitary adenoma (> 4cm in diameter)
Who cannot join
- most of the tumor were in the sellae, sphenoidal sinus or clivus.
- patients with craniopharyngioma or meningioma.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Changzhi People's Hospital
Changzhi, Shanxi
Chongqing People's Hospital
Chongqing, Chongqing Municipality
The first affliated hospital of Fujian Medical Hospital
Fuzhou, Fujian, 350005
The First Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
The first affliated hospital of Kunming Medical University
Kunming, Yunnan
General hospital of Eastern Theater Command
Nanjing, Jiangsu
Huashan Hospital
Shanghai, Shanghai Municipality, 20000
Shanghai General Hospital
Shanghai, Shanghai Municipality, 20000
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 20000
The First Affiliated Hospital of China Medical University
Shenyang, Jilin
The first hospital of Shanxi Medical University
Taiyuan, Shanxi
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
About this study
The surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options.
A single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor.
Read more
The advantage of the combined approach is that the tumor can be removed to the greatest extent possible. In addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. In this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced.
In some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. However, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors.
Given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.
- Conditions
- Surgery, Pituitary Adenoma
- Being tested
- Two different approaches, Non-combined approach
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two different approachesProcedure or surgery
Please refer to Groups
Non-combined approachProcedure or surgery
Either transnasal, transcranial or a staged approach
| Study group | Role | What they receive |
|---|---|---|
| Non-combined approach (Single or Staged) | Active comparator | Patients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery Receives: Procedure: Non-combined approach |
| Combined approach | Experimental | Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously Receives: Procedure: Two different approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extend of resection
how much tumor was resected
Measured: One month after surgery
Secondary outcomes (3)
Risks
Proportion of Participants with hemorrage, infection or cranial nerve defect
Measured: One month after surgery
Relapse or Mortality
Death from any cause
Measured: From date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgery
Karnofsky performance score
Ranged from 0 to 100, the higher scores mean a better outcome
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
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 SurgeryStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448690
- Sponsor's protocol ID
- KY2022-060
- Status last verified
- Oct 2024
- First submitted
- 2 Jul 2022
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qiao N, Gao W, Deng X, Xin T, Zhang G, Wu N, Wang P, Bi Y, Cong Z, Zhou Z, Li J, Sun S, Li M, Tang W, Yan X, Wang W, Qiu W, Yao S, Ye Z, Ma Z, Zhou X, Cao X, Shen M, Shou X, Zhang Z, Wu Z, Chu L, Qiu Y, Ma H, Wu A, Ma C, Lou M, Jiang C, Wang Y, Zhao Y. Combined simultaneous transsphenoidal and transcranial regimen improves surgical outcomes in complex giant pituitary adenomas: a longitudinal retrospective cohort study. Int J Surg. 2024 Jul 1;110(7):4043-4052. doi: 10.1097/JS9.0000000000001330.
PubMed 38498406
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT05448690
- Acronym / sponsor ID
- KY2022-060
- Conditions
- Surgery, Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Jul 2022 (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 surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options.
A single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor.
The advantage of the combined approach is that the tumor can be removed to the greatest extent possible. In addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. In this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced.
In some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. However, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors.
Given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-combined approach (Single or Staged) | Active comparator | Procedure: Non-combined approachPatients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery |
| Combined approach | Experimental | Procedure: Two different approachesPatients underwent a combined approach using transnasal approach and craniotomy approach simultaneously |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Giant pituitary adenoma (> 4cm in diameter)
Key exclusion criteria (2 listed)
- most of the tumor were in the sellae, sphenoidal sinus or clivus.
- patients with craniopharyngioma or meningioma.
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 |
|---|---|---|
| Two different approachesPlease refer to Groups | Procedure or surgery | Combined approach |
| Non-combined approachEither transnasal, transcranial or a staged approach | Procedure or surgery | Non-combined approach (Single or Staged) |
Primary outcome
Extend of resection
Time frame: One month after surgery
how much tumor was resected
3 secondary outcomes
Risks
Time frame: One month after surgery
Relapse or Mortality
Time frame: From date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgery
Karnofsky performance score
Time frame: Three months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 38498406Qiao N, Gao W, Deng X, Xin T, Zhang G, Wu N, Wang P, Bi Y, Cong Z, Zhou Z, Li J, Sun S, Li M, Tang W, Yan X, Wang W, Qiu W, Yao S, Ye Z, Ma Z, Zhou X, Cao X, Shen M, Shou X, Zhang Z, Wu Z, Chu L, Qiu Y, Ma H, Wu A, Ma C, Lou M, Jiang C, Wang Y, Zhao Y. Combined simultaneous transsphenoidal and transcranial regimen improves surgical outcomes in complex giant pituitary adenomas: a longitudinal retrospective cohort study. Int J Surg. 2024 Jul 1;110(7):4043-4052. doi: 10.1097/JS9.0000000000001330.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two different approaches and Non-combined approach in people with Surgery and Pituitary Adenoma, run by Huashan Hospital at 13 sites in China.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extend of resection (time frame: One month 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 NCT05448690, 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 29 Oct 2024.