Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study

Recruiting now · Phase 2

Conditions studied: Sellar Tumor, Endonasal Surgery, Csf Leakage

In brief

Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery. Secondary objectives: 1. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery; 2. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay; 3. To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.

Key facts

Study ID

NCT07539792

Run by

Nanfang Hospital, Southern Medical University

People needed

126

Starts

2026-04-01

Expected to finish

2030-02-28

Last updated by the study team

2026-04-20

Who can join

Age: 1 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 1-80 years, regardless of gender;
• Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;
• Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;
• Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;
• Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;
• Sign the informed consent form and are willing to participate in the study.

You may not qualify if…

• Patients with other concurrent intracranial tumors or severe brain lesions;
• Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
• Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
• Pregnant or lactating women;
• Patients who have previously received radiotherapy or chemotherapy;
• Patients with active nasal infections, inflammation, or severe nasal diseases;
• Patients with a history of severe allergies to drugs or synthetic materials;
• Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;
• Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.

Where it is running

• Southern Medical University, Nanfang Hospital, Department of Neurosurgery — Guangzhou, Guangdong, China (enrolling)
• Gaozhou People's Hospital — Gaozhou, Guangdong, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China
• Huizhou Central People's Hospital — Huizhou, Guangdong, China
• The First People's Hospital of Zhaoqing — Zhaoqing, Guangdong, China
• The First People's Hospital Of Foshan — Foshan, Guangdong, China
• Liuzhou people's hospital — Liuzhou, Guangxi, China

Full record on ClinicalTrials.gov

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