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

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.

Study Overview

• Status: Recruiting
• Conditions: Csf Leakage; Sellar Tumor; Endonasal Surgery
• Intervention / Treatment: Device: Absorbable and moldable skull base support plate

Detailed Description

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):

Refers to the set of all subjects who have received the trial after enrollment and have undergone at least one safety indicator evaluation.

- Per Protocol Set (PPS): The set of cases in the Full Analysis Set that have completed the trial as specified in the protocol and have no serious violations of the trial protocol.

This is a phase II clinical trial. The sample size of this study will be calculated based on the hypothesis of a 1:1 parallel design sample rate in the two groups. The specific method is to compare the incidence of CSF rhinorrhea (CSF Leakage Rate, CLR) within 1 month after surgery in the experimental group (i.e., standard sellar floor repair + absorbable and moldable skull base support plate repair group) with that in the standard sellar floor repair group. It is assumed that the CLR in the experimental group is 1% (p1=0.01) and that in the standard sellar floor repair group is 15% (p2=0.15). The significance level is set at 0.025 (one-sided test), and the power is 80%. According to literature references and study design, we expect to recruit approximately 56 subjects in each group. Allowing for a 10% loss to follow-up, the sample size will be increased to N = 126 (63 subjects per group).

All statistical analyses will be performed using SAS 9.2 statistical analysis software.

Follow-up Face-to-face oral follow-up will be conducted for patients who return to the hospital for reexamination, and telephone follow-up will be conducted for patients who cannot return to the hospital for reexamination.

Statistical Methods

Data Processing:

Data processing and analysis will be performed using SAS 9.2 statistical analysis software. All continuous variables will be expressed as mean ± standard deviation (Mean ± SD) or median (interquartile range), and categorical variables will be expressed as frequency and percentage.

Analysis of Primary Efficacy Indicators:

Incidence of CSF rhinorrhea (CLR) within 1 month after surgery: Evaluated according to clinical symptoms, imaging, and nasal endoscopy standards. Chi-square test or Fisher's exact test will be used to analyze the CLR of each group.

Analysis of Secondary Efficacy Indicators:

• Incidence of intracranial infection within 1 month after surgery: Inter-group analysis will be performed using chi-square test or Fisher's exact test.
• Utilization rate of autologous fascia, fat, and nasal septum mucosal flaps: Inter-group analysis will be performed using chi-square test or Fisher's exact test.
• Length of duration of the surgery and postoperative hospital stay: Inter-group analysis will be performed using t-test or non-parametric test.

Safety Analysis:

Treatment-related adverse events will be evaluated according to the CTCAE 5.0 standard. The incidence of adverse events in each group will be analyzed using chi-square test or Fisher's exact test, and the frequency and severity of adverse events will be described by category.

Significance Level:

All statistical tests are two-sided tests, and the significance level is set at P < 0.05. P < 0.05 is considered statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Not yet recruiting
      • The First People's Hospital of Foshan
      • Contact: Lianxu Cui; Phone Number: +86-18038863001; Email: cuilianxu@qq.com
      • Principal Investigator: Lianxu Cui
    • Gaozhou, Guangdong, China
      • Not yet recruiting
      • Gaozhou People's Hospital
      • Contact: Linfan Li; Phone Number: +86-138 2488 0022
      • Contact: Email: lmj1006@yeah.net
      • Principal Investigator: Linfan Li
    • Guangzhou, Guangdong, China, 510060
      • Not yet recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Xiaobing Jiang, MD, Ph.D; Phone Number: +86-15201253009; Email: jiangxiaob1@sysucc.org.cn
      • Principal Investigator: XIaobing Jiang, MD, Ph.D
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Principal Investigator: Tao Huang
      • Contact: Tao Huang; Phone Number: +86-18688898958; Email: arteries@163.com
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Southern Medical University, Nanfang Hospital, Department of Neurosurgery
      • Principal Investigator: Jun Pan, MD, Ph.D
      • Sub-Investigator: Yilamujiang Ainiwan, Ph.D
      • Sub-Investigator: Junxiang Peng, Ph.D
      • Sub-Investigator: Jing Nie, Ph.D
      • Sub-Investigator: Mingfeng Zhou, Ph.D
      • Sub-Investigator: Jian Mao, Ph.D
    • Huizhou, Guangdong, China
      • Not yet recruiting
      • Huizhou Central People's Hospital
      • Contact: Honghai Luo, Master of Medical Science; Phone Number: +86-15820717999; Email: luohonghai999@sohu.com
      • Principal Investigator: Honghai Luo, Master of Medical Science
    • Zhaoqing, Guangdong, China
      • Not yet recruiting
      • The First People's Hospital of Zhaoqing
      • Contact: Haibin Li; Phone Number: +86-13560917978; Email: Lihaibin08@126.com
      • Principal Investigator: Haibin Li
  • Guangxi
    • Liuchow, Guangxi, China
      • Not yet recruiting
      • Liuzhou People's Hospital
      • Contact: Yuanliang Ye; Phone Number: +86-13667726163; Email: yeyuanliangy@163.com
      • Principal Investigator: Yuanliang Ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Absorbable and moldable skull base support plate; 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intracranial infection	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.; Confirmed by pathogenic examination of cerebrospinal fluid via lumbar puncture.	Within 1 month postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization rate of autologous fascia, fat, and pedicled mucosal flap	Utilization rate of autologous fascia, fat, and pedicled mucosal flap during the surgery.	Intraoperative
Operation duration	Operation duration of the surgery	Intraoperative
Length of postoperative hospital stay	Time spended in the hosptial after the surgery	Within 1 month postoperatively
Incidence of long-term nasal complications	Evaluated based on the participant's symptom descriptions and otolaryngology outpatient assessments.	Within 1 year postoperatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sellar Tumor; Extended Endoscopic Endonasal Transsphenoidal Surgery; Cerebrospinal Fluid Rhinorrhea; Skull Base Reconstruction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebrospinal Fluid Leak; Rhinorrhea; Cerebrospinal Fluid Rhinorrhea
• Other Study ID Numbers: NFEC-2026-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No