UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057898 |
|---|---|
| Receipt number | R000066180 |
| Scientific Title | A Multi-Institutional Registry Study to Evaluate the Efficacy and Safety of Endoscopic Skull Base Surgery |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/07/03 16:30:21 |
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Basic information
Public title
A Multi-Institutional Endoscopic Skull Base Surgery Registry Study (ESBS-R)
Acronym
ESBS-R
Scientific Title
A Multi-Institutional Registry Study to Evaluate the Efficacy and Safety of Endoscopic Skull Base Surgery
Scientific Title:Acronym
ESBS-R
Region
| Japan |
Condition
Condition
Patients who underwent endoscopic skull base surgery (ESBS) at each participating institution for diagnostic or therapeutic purposes were included. The targeted pathologies included, but were not limited to, the following: pituitary neuroendocrine tumor (PitNET), Rathke's cleft cyst, meningioma, craniopharyngioma, chordoma, chondrosarcoma, epidermoid cyst, colloid cyst, germ cell tumor, olfactory neuroblastoma, schwannoma, and other rare lesions such as suprasellar hemangioblastoma, arachnoid cyst, hypophysitis, xanthogranuloma, glioma, and solitary fibrous tumor.
Classification by specialty
| Neurosurgery | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of endoscopic skull base surgery (ESBS) using both retrospective and prospective data collected from multiple specialized centers. Specifically, it seeks to clarify tumor resection rates, improvement in neurological function, incidence and risk factors of postoperative complications (e.g., cerebrospinal fluid leak, infection, cranial nerve deficits), the relationship between surgical techniques or perioperative management and clinical outcomes, and inter-institutional variability in treatment results. The ultimate goal is to establish safe, effective, and standardized surgical strategies and management protocols, thereby contributing to improved quality and consistency of skull base surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the therapeutic efficacy and surgical safety of ESBS
Indicators of efficacy: extent of tumor resection, recurrence rate, overall survival
Indicators of safety: incidence of postoperative complications (e.g., cerebrospinal fluid leak, meningitis, visual impairment, hemorrhage, hypopituitarism)
Key secondary outcomes
Relationship between tumor characteristics (type, location, size, structure) and clinical outcomes/complication rates
Association between reconstruction methods and the use of drainage with postoperative CSF leakage and infection
Impact of surgeon experience and institutional factors on surgical outcomes (extent of resection, complication rates)
Influence of perioperative management (e.g., antibiotic use, drain management) on postoperative infection and patient quality of life (QOL)
Improvement rates and predictive factors for functional outcomes such as vision, olfaction, and hormonal function
Incidence, timing, and predictive factors of tumor recurrence and reoperation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Cases in which endoscopic skull base surgery (ESBS) was performed at participating institutions between January 1, 2000, and March 31, 2030.
2. The surgery was performed for diagnostic or therapeutic purposes and involved an endoscopic approach to a skull base lesion.
3. Preoperative and postoperative clinical information, including medical records and imaging data, is accessible for review.
4. Cases analyzed only after the date on which the head of the institution approved the conduct of the study.
Key exclusion criteria
1. Cases that clearly do not qualify as ESBS, such as surgeries performed exclusively under the microscope without the use of an endoscope.
2. Cases with significantly incomplete medical records or imaging data, making it impossible to assess key outcome measures (e.g., extent of resection, complications).
3. Cases deemed clearly ineligible based on the objectives of this study (e.g., surgeries performed for purposes unrelated to the study scope).
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Hasegawa |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Neurosurgery
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3671
hirotaka.hasegawa@ymail.ne.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Hasegawa |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Neurosurgery
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3671
Homepage URL
hirotaka.hasegawa@ymail.ne.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Saitama Medical Center Clinical Research Support Center
Address
1981 Kamoda, Kawagoe, Saitama
Tel
049-228-3902
smcrinri@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now recruting
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066180
