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

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

This trial will test whether adding an absorbable, moldable skull base support plate during extended endoscopic endonasal transsphenoidal surgery reduces cerebrospinal fluid rhinorrhea in people with sellar region tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 1 Year to 80 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Foshan, Guangdong and 7 other locations)
• Trial ID: NCT07539792 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Patients aged 1–80 with confirmed sellar region tumors who are planned for extended endoscopic endonasal transsphenoidal surgery, have a Karnofsky Performance Status ≥70, acceptable lab results, and can provide informed consent are appropriate candidates.

Not a fit: Patients requiring craniotomy or non-extended endonasal approaches, those with uncontrolled severe heart/lung/kidney/liver disease, concurrent intracranial tumors, prior radiotherapy or chemotherapy, or who are pregnant or lactating are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the approach could lower postoperative CSF leak rates and related infections, shorten hospital stays, and reduce the need for additional interventions.

How similar studies have performed: Previous case series and device reports of multilayer skull base reconstruction and absorbable plates have suggested reduced postoperative CSF leak rates, but high-quality randomized data are limited.

Eligibility criteria

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 this trial is running

Foshan, Guangdong and 7 other locations

• 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)
• Southern Medical University, Nanfang Hospital, Department of Neurosurgery — Guangzhou, Guangdong, China (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)
• The First People's Hospital of Zhaoqing — Zhaoqing, Guangdong, China (Not_yet_recruiting)
• Liuzhou people's hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jun Pan MD, Ph.D

Conditions Sellar Tumor; Endonasal Surgery; Csf Leakage; Extended Endoscopic Endonasal Transsphenoidal Surgery; Cerebrospinal Fluid Rhinorrhea; Skull Base Reconstruction