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

NCT07539792 | Recruiting Phase 2

• 1 other identifier: NFEC-2026-111
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 8

Brief Summary

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. 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. 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. 3.To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.

Conditions

Sellar Tumor; Endonasal Surgery; Csf Leakage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of cerebrospinal fluid (CSF) rhinorrhea

  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.

  Within 1 month postoperatively

Secondary Outcomes (1)

• Incidence of intracranial infection

  Within 1 month postoperatively

Other Outcomes (4)

• Utilization rate of autologous fascia, fat, and pedicled mucosal flap

  Intraoperative

• Operation duration

  Intraoperative

• Length of postoperative hospital stay

  Within 1 month postoperatively

Study Arms (2)

Standard skull base reconstruction plus the absorbable and moldable skull base support plate

EXPERIMENTAL

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

Device: Absorbable and moldable skull base support plate

Standard skull base reconstruction protocol

NO INTERVENTION

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

Interventions

Absorbable and moldable skull base support plate DEVICE

The sbsorbable and moldable skull base support plate is used during the skull base repair phase of the surgery. Trimming: Measure the size of the skull base defect bone window (from the tuberculum sellae to the clival bone edge). Cut the malleable support plate slightly longer than this dimension. Shaping: Shape the plate according to the morphological changes of the sellar floor bone resulting from the lesion. In cases with no obvious sellar floor bone destruction (e.g., suprasellar craniopharyngioma), the support plate is shaped into a slight "S" curve to ensure tight apposition to the dural window and the inlay artificial dura, preventing the formation of intervening gaps. Placement: Since the support plate requires tight embedding under the anterior and posterior bone edges, bone edges at the tuberculum sellae and clivus should be preserved during sellar floor drilling according to surgical exposure and plate embedding requirements to facilitate secure fixation.

Standard skull base reconstruction plus the absorbable and moldable skull base support plate

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• The First People's Hospital of Zhaoqing: collaborator
• Sun Yat-Sen University Cancer Center: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• The People's Hospital of Gaozhou: collaborator
• First People's Hospital of Foshan: collaborator
• Huizhou Municipal Central Hospital: collaborator
• LiuZhou People's Hospital: collaborator

Study Sites (8)

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, 510060, China

NOT YET RECRUITING

Southern Medical University, Nanfang Hospital, Department of Neurosurgery

Guangzhou, Guangdong, 510515, 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

Liuchow, Guangxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid Leak; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rhinorrhea; Signs and Symptoms, Respiratory; Wounds and Injuries

Central Study Contacts

Jun Pan MD, Ph.D

CONTACT

+86-13076878155; 1448875873@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (8)