Clinical trial · Interventional
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
NCT07539792CI-TRIAL-00108849EEEA-AMSBPrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Csf Leakage | — | UNRESOLVED | — |
| Endonasal Surgery | — | UNRESOLVED | — |
| Sellar Tumor | Sellar Region Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Absorbable and moldable skull base support plate | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard skull base reconstruction plus the absorbable and moldable skull base support plate
- description
- 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
- interventionNames
- Device: Absorbable and moldable skull base support plate
- type
- NO_INTERVENTION
- label
- Standard skull base reconstruction protocol
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.