Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT07216157
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}, {'id': 'D002558', 'term': 'Cerebrospinal Fluid Otorrhea'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-23', 'size': 335188, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-09T07:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2025-09-28', 'studyFirstSubmitQcDate': '2025-10-09', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative cerebrospinal fluid (CSF) leak within 90 days', 'timeFrame': '90 days', 'description': 'Postoperative CSF leak will be assessed clinically and endoscopically at multiple time points (Day 2, Day 30, Day 90). A leak will be defined as visible or symptomatic leakage of cerebrospinal fluid from the nasal cavity, confirmed by clinical exam and/or imaging when necessary. Assessment will be blinded and recorded using standardized diagnostic criteria.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['csf', 'pituitary adenoma', 'csf leak', 'sealant'], 'conditions': ['CerebroSpinal Fluid (CSF) Leak']}, 'descriptionModule': {'briefSummary': 'Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI/PEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients.', 'detailedDescription': 'Introduction Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI/PEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients. Materials and Methods This is a prospective, randomized, controlled, single-center clinical trial conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland.\n\nAdult patients scheduled for endoscopic endonasal surgery (EES) will first undergo screening based on medical history and detailed radiological evaluation. Those who meet all predefined inclusion and exclusion criteria will be enrolled and randomized preoperatively using a computer-generated allocation sequence into one of three treatment arms: (1) no sealant (standard multilayer closure), (2) fibrin glue application (Tisseel®), or (3) synthetic polyethylene glycol-based sealant (Adherus®). Following randomization, surgery will be performed in accordance with the assigned intervention. The primary endpoint is the incidence of postoperative cerebrospinal fluid (CSF) leak within 3 months. Secondary outcomes include endoscopic evaluation of mucosal healing at 6 weeks and 3 months, postoperative complication rates (e.g., meningitis, pneumocephalus), reoperation rate, patient-reported quality of life, and a cost-effectiveness analysis comparing sealant use to standard closure. The study is designed and will be reported in accordance with the SPIRIT 2025 (Standard Protocol Items: Recommendations for Interventional Trials) guidelines to ensure methodological transparency and reproducibility. Results Initial enrollment includes a target of 225 patients (75 per arm). Interim data analysis focuses on early healing parameters, safety profiles, and cost metrics. Hypothesis testing will determine if either sealant significantly reduces CSF leak rates compared to no sealant and whether the marginal benefit justifies routine use in all patients. Exploratory endpoints include biomaterial handling characteristics and surgeon-reported usability. Conclusion The NoSeal Trial addresses a critical gap in evidence regarding the necessity and comparative performance of sealants in skull base reconstruction. By evaluating both clinical outcomes and economic impact, the study seeks to optimize surgical protocols and improve the safety and efficiency of endonasal neurosurgical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction\n* Informed written consent obtained prior to enrollment\n* Hemodynamic and electrolyte stability before surgery\n* Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques\n\nExclusion Criteria:\n\n* Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects)\n* Tumors requiring complex sella reconstruction from the start\n* Preoperative hydrocephalus\n* Known allergy to fibrin-based or synthetic sealant components\n* Active sinus infection or systemic inflammatory disease\n* Prior radiotherapy to the sellar or parasellar region\n* Uncontrolled diabetes mellitus (HbA1c \\> 7.0%)\n* Participation in another interventional trial that may influence wound healing or CSF assessment\n* Radiologic signs of chronic intracranial hypertension or hypotension'}, 'identificationModule': {'nctId': 'NCT07216157', 'acronym': 'NoSeal', 'briefTitle': 'NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'The NoSeal Trial - Nasal Outcome Study Evaluating Artificial Leak-Sealing: A Prospective, Randomized, Controlled, Single-Blinded, Single-Center Clinical Trial Comparing Fibrin Glue (Tisseel®) and a Two-Component Synthetic Polymer Sealant (PEI/PEG, Adherus®) Versus No Sealant for the Prevention of Cerebrospinal Fluid Leak and Promotion of Wound Healing Following Endonasal Skull Base Surgery, Designed in Accordance With the SPIRIT 2025 Guidelines', 'orgStudyIdInfo': {'id': 'NIO-NS2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No Sealant - Standard Multilayer Closure', 'description': 'Patients in this arm will receive standard multilayer closure without the use of any sealant. Closure will involve mucosal flap repositioning and hemostatic agents (e.g., Surgicel®, TachoSil®), in accordance with standard endoscopic skull base reconstruction techniques.', 'interventionNames': ['Procedure: Standard multilayer closure without sealant']}, {'type': 'EXPERIMENTAL', 'label': 'Fibrin Glue - Tisseel® Application', 'description': 'Patients will undergo standard multilayer closure followed by application of fibrin sealant (Tisseel®). This arm evaluates the effect of biologic tissue glue in preventing postoperative CSF leaks and promoting wound healing following endonasal skull base surgery.', 'interventionNames': ['Device: Fibrin sealant application']}, {'type': 'EXPERIMENTAL', 'label': 'Synthetic Sealant - Adherus® Application', 'description': "This arm involves standard multilayer closure followed by the application of a two-component synthetic polyethylene glycol-based sealant (Adherus®). The objective is to evaluate the synthetic agent's efficacy and cost-effectiveness in reducing postoperative CSF leaks.", 'interventionNames': ['Device: Synthetic polyethylene glycol-based sealant']}], 'interventions': [{'name': 'Standard multilayer closure without sealant', 'type': 'PROCEDURE', 'otherNames': ['No-sealant technique', 'Control arm'], 'description': 'Patients will undergo standard skull base reconstruction using mucosal flap repositioning and absorbable hemostatics (e.g., Surgicel®, TachoSil®), without application of any fibrin or synthetic sealant. This serves as the control group for comparison with sealant-assisted closures.', 'armGroupLabels': ['No Sealant - Standard Multilayer Closure']}, {'name': 'Fibrin sealant application', 'type': 'DEVICE', 'otherNames': ['Tisseel®', 'Fibrin glue', 'Human fibrinogen/thrombin sealant'], 'description': 'Following standard multilayer closure, patients in this group will receive topical application of a fibrin-based biological sealant (Tisseel®). The intervention aims to assess its effectiveness in preventing postoperative cerebrospinal fluid (CSF) leak and promoting mucosal healing after endoscopic endonasal skull base surgery.', 'armGroupLabels': ['Fibrin Glue - Tisseel® Application']}, {'name': 'Synthetic polyethylene glycol-based sealant', 'type': 'DEVICE', 'otherNames': ['Adherus®', 'PEI/PEG sealant', 'Synthetic dural sealant'], 'description': 'After standard multilayer closure, a synthetic two-component sealant (Adherus®, composed of polyethylene glycol and polyethylenimine) will be applied to reinforce the reconstruction site. This group is used to evaluate the efficacy and safety of synthetic sealant in preventing CSF leaks and supporting wound healing.', 'armGroupLabels': ['Synthetic Sealant - Adherus® Application']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Institute - Oncology Center', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Wojciech Czyzewski, MD PhD, MD PhD', 'role': 'CONTACT', 'email': 'wojciech.w.czyzewski@gmail.com', 'phone': '+48788599550'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'De-identified individual participant data (IPD) and supporting documentation will be available beginning 6 months after publication of the primary results and will remain accessible for up to 36 months.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) to be shared will include:\n\nDemographics (age, sex) Preoperative imaging risk features Intraoperative findings (CSF leak grade, reconstruction technique) Treatment allocation (sealant type or no sealant) Primary and secondary outcomes (e.g., CSF leak occurrence, mucosal healing scores, complication rates, SNOT-22 and VAS scores) Follow-up data at 4 and 12 weeks Reoperation status Adverse events', 'accessCriteria': 'Access will be granted to qualified researchers affiliated with academic or non-commercial institutions who submit a methodologically sound research proposal. Access will include de-identified IPD and supporting documents (protocol, SAP, ICF, CSR, analytic code). Requests should be sent to the corresponding author. Data will be shared via secure institutional data-sharing platforms upon approval of the proposal and execution of a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wojciech Czyżewski MD, PhD, Neurosurgery Specialist, Principal Investigator', 'investigatorFullName': 'Wojciech Czyżewski', 'investigatorAffiliation': 'Maria Sklodowska-Curie National Research Institute of Oncology'}}}}