Absorbable, moldable skull base support plates to reduce cerebrospinal fluid leaks after extended endoscopic endonasal transsphenoidal surgery.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label phase II trial enrolls patients with sellar region tumors scheduled for extended endoscopic endonasal transsphenoidal surgery and randomizes them 1:1 to standard sellar floor repair alone or standard repair plus an absorbable, moldable skull base support plate. The primary endpoint is the incidence of CSF rhinorrhea within one month after surgery, with secondary endpoints including intracranial infection, operative time, length of postoperative hospital stay, and nasal complications. Safety will be monitored using predefined analysis sets (FAS, PPS, SS) and the sample size is calculated to detect differences in one‑month CSF leak rates. The trial is conducted at multiple centers in Guangdong province, China, to inform surgical reconstruction practices after extended endonasal skull base procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Southern Medical University, Nanfang Hospital, Department of Neurosurgery
  Guangzhou, Guangdong, China Recruiting
• The First People's Hospital Of Foshan
  Foshan, Guangdong, China Not yet recruiting
• Gaozhou People's Hospital
  Gaozhou, Guangdong, China Not yet recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting
• Guangdong Provincial Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Not yet recruiting
• Huizhou Central People's Hospital
  Huizhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Jun Pan MD, Ph.D
• Email: 1448875873@qq.com
• Phone: +86-13076878155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.