Chitosan Scaffold for Sellar Floor Repair in Endoscopic Endonasal Transsphenoidal Surgery

NCT03280849 | Completed DMC

• 1 other identifier: CI.064.2015
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Csf Leakage

Keywords

chitosan; endoscopic; sellar tumor; biomaterials; transphenoidal

Outcome Measures

Primary Outcomes (10)

• Brain MRI with and without contrast

  Axial-coronal-sagittal MRI in T1,T2 signals-measure of the preoperative tumor size

  1 day preoperative

• Brain MRI with and without contrast

  Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor size

  1 day postoperative

• Head CT scan

  Bone window was used to see the repair of bone defect after surgery

  1 month postoperative

• Brain MRI with and without contrast

  Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  1 month postoperative

• Brain MRI with and without contrast

  Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  6 months postoperative

• Brain MRI with and without contrast

  Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  1 year postoperative

• Brain MRI with and without contrast

  Axial-coronal-sagittal MRI in T1,T2 signals-measure of the postoperative tumor

  2 years postoperative

• Head CT scan

  Bone window was used to see the repair of bone defect after surgery

  6months postoperative

• Head CT scan

  Bone window was used to see the repair of bone defect after surgery

  1 year postoperative

• Head CT scan

  Bone window was used to see the repair of bone defect after surgery

  2 years postoperative

Secondary Outcomes (10)

• Visual field test

  1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.

• Snellen test

  1 day preoperative, follow up: 1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.

• Glasgow scale

  1 day preoperative, follow up :1 day postoperative, 15 days postoperative, 1 month postoperative, 6 months postoperative, 1 year postoperative, 2 years postoperative.

• Endocrinological panel

  1 day preoperative, follow up : 1 day postoperative, 15 days postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative

• Blood cell count

  1 day preoperative, follow up: 1 day postoperative , 1 month postoperative, 6 months postoperative,1 year postoperative, 2 years postoperative

Study Arms (1)

Patient with bilaminar chitosan implant

EXPERIMENTAL

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

Interventions

Implant of bilaminar chitosan scaffold OTHER

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.

Also known as: Endoscopic endonasal transphenoidal surgery

Patient with bilaminar chitosan implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Departamento de neurociencias

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (24)

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Related Links

• website of our institute of traslational neurosciences
• website of our center
• website of our hospital facilities

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

Study Officials

• Rodrigo Ramos Zuñiga, M.D. PhD

  University of Guadalajara

  STUDY CHAIR

• Brenda Vega Ruiz, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

• Ivan Segura Duran, M.D.

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 13, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)