Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 8
- 主要终点
- Incidence of cerebrospinal fluid (CSF) rhinorrhea
研究概览
简要总结
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:
- 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;
- 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;
- To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.
详细描述
This is a multicenter, two-arm, open-label, randomized, controlled phase II clinical trial. It plans to enroll patients with sellar region tumors who will undergo extended endoscopic endonasal transsphenoidal approach. The aim is to compare the incidence of CSF rhinorrhea within 1 month after surgery between the combination of standard sellar floor repair + absorbable and moldable skull base support plate repair and the standard sellar floor repair group, and evaluate its safety and efficacy, so as to provide new strategies and basis for clinical treatment.
Statistical Analysis:
Analysis Sets:
Full Analysis Set (FAS), Per Protocol Set (PPS), and Safety Set (SS) will be used for statistical analysis.
- Full Analysis Set (FAS): Refers to the set of all subjects who have received the trial after enrollment and have undergone at least one efficacy assessment.
- Safety Set (SS):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard skull base reconstruction plus the absorbable and moldable skull base support plate
The intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach :
Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification).
Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.).
Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer.
Trimming, shaping, and placement of the skull base support plate. Covering with mucosa: Cover the outer surface of the support plate with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge
干预措施: Absorbable and moldable skull base support plate (Device)
Standard skull base reconstruction protocol
No intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach : Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification). Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.). Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer. Cover with mucosa: Cover the outer surface of the dural layer with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge
结局指标
主要结局
Incidence of cerebrospinal fluid (CSF) rhinorrhea
时间窗: Within 1 month postoperatively
Confirmed by combining clinical symptoms, imaging examinations, and nasal endoscopy, including but not limited to the following indicators: Clinical symptoms: persistent high fever (maximum temperature \> 38.5 °C for more than 3 days), nausea and vomiting, decreased consciousness, positive meningeal irritation signs, etc.; Imaging examinations: CT or MRI showing fluid accumulation in the paranasal sinuses, intracranial pneumocephalus, etc.; Nasal endoscopy demonstrating persistent cerebrospinal fluid leakage from the sellar floor wound.
次要结局
- Incidence of intracranial infection(Within 1 month postoperatively)