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Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery

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ClinicalTrials.gov Identifier: NCT03280849
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A 65 year old female participant , right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, the participant underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor. After a follow up of 2 years the participant returned to its normal visual function, without evidence of the sellar lesion on the postoperative MRI, and without complications.

Condition or disease Intervention/treatment
Csf Leakage Other: Implant of bilaminar chitosan scaffold

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Use of a novel bilaminar chitosan scaffold in the repair of the sellar floor after an endoscopic endonasal transsphenoidal surgery for a suspected hipofisary macroadenoma.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery
Actual Study Start Date : January 2015
Primary Completion Date : January 2017
Study Completion Date : February 2017

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MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Patient with bilaminar chitosan implant
A 65 year old woman, right handed, started with progressive bilateral visual loss in her temporal field, over 10 months, she underwent an MRI and it was found a sellar lesion that compressed the optic chiasm, an endoscopic endonasal transsphenoidal surgery was done for the resection of the lesion, using a novel bilaminar chitosan scaffold to assist the closure of the sellar floor.
Other: Implant of bilaminar chitosan scaffold
The patient underwent endoscopic endonasal transsphenoidal surgery for resection of the sellar lesion, under the direct visualization, the lesion appeared redish and soft with moderately bleeding, a sample was taken for pathology and the remaining is extracted without complications, then the scaffold is implanted in the site of the bone defect in the sphenoid sinus, due to its moldable nature, it was easily set, covering the entire extension of the defect, a fat graft was set in the sphenoid sinus covering the bilaminar chitosan membrane, then fibrin sealant was used for hemostatic control and a nasal packing was set in both nostrils for finalize the procedure.
Other Name: Endoscopic endonasal transphenoidal surgery


Outcome Measures

Primary Outcome Measures :
  1. Brain MRI with and without contrast [ Time Frame: 1 day preoperative ]
    Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size

  2. Brain MRI with and without contrast [ Time Frame: 1 day postoperative ]
    Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor size

  3. Head CT scan [ Time Frame: 1 month postoperative ]
    Bone window was used to see the repair of bone defect after surgery

  4. Brain MRI with and without contrast [ Time Frame: 1 month postoperative ]
    Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  5. Brain MRI with and without contrast [ Time Frame: 6 months postoperative ]
    Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  6. Brain MRI with and without contrast [ Time Frame: 1 year postoperative ]
    Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  7. Brain MRI with and without contrast [ Time Frame: 2 years postoperative ]
    Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  8. Head CT scan [ Time Frame: 6months postoperative ]
    Bone window was used to see the repair of bone defect after surgery

  9. Head CT scan [ Time Frame: 1 year postoperative ]
    Bone window was used to see the repair of bone defect after surgery

  10. Head CT scan [ Time Frame: 2 years postoperative ]
    Bone window was used to see the repair of bone defect after surgery


Secondary Outcome Measures :
  1. Visual field test [ Time Frame: 1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative. ]
    visual field testing looking for compression of optic chiasm

  2. Snellen test [ Time Frame: 1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative. ]
    visual acuity testing

  3. Glasgow scale [ Time Frame: 1 day preoperative, follow up :1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative. ]
    level of consciousness

  4. Endocrinological panel [ Time Frame: 1 day preoperative, follow up : 1 day postoperative, 15 days postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    evaluation of hipofisary function

  5. Blood cell count [ Time Frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    For evaluation of any inflammatory reaction or infection before or after the procedure

  6. acute phase reactans [ Time Frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    For evaluation of any inflammatory reaction or infection before or after the procedure

  7. blood electrolytesand [ Time Frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    evaluation of renal function and as requirement for surgery

  8. liver function test [ Time Frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    evaluation of liver function and as requirement for surgery

  9. coagulation test [ Time Frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    secondary evaluation of liver function, inflammatory reaction or infection before and after the procedure and as requirement for surgery.

  10. seric creatinine [ Time Frame: 1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative ]
    evaluation of renal function and as requirement for surgery


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure.

Exclusion Criteria:

  • Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280849


Locations
Mexico
Departamento de neurociencias
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
Study Chair: Rodrigo Ramos Zuñiga, M.D. PhD University of Guadalajara
Principal Investigator: Brenda Vega Ruiz, PhD University of Guadalajara
Principal Investigator: Ivan Segura Duran, M.D. University of Guadalajara
More Information

Additional Information:
Publications:

Responsible Party: Ivan Segura Duran, M.D., University of Guadalajara
ClinicalTrials.gov Identifier: NCT03280849     History of Changes
Other Study ID Numbers: CI.064.2015
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: complete MRI sequences, laboratory studies, visual field tests, complete biomaterial patent registration , clinical reports.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ivan Segura Duran, University of Guadalajara:
chitosan
endoscopic
sellar tumor
biomaterials
transphenoidal

Additional relevant MeSH terms:
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants