A Multi-Institutional Endoscopic Skull Base Surgery Registry Study (ESBS-R)

A Multi-Institutional Registry Study to Evaluate the Efficacy and Safety of Endoscopic Skull Base Surgery - ESBS-R

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057898

Enrollment

2000

Registered

2025-07-01

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

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&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHirotaka Hasegawa

Saitama Medical Center, Saitama Medical University Neurosurgery

hirotaka.hasegawa@ymail.ne.jp049-228-3671

Outcome results