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Skull Base NeoplasmsNCT03448614

Skull Base Reconstruction After Endonasal Cranio-endoscopic Resection Using Autologus Grafts

An observational study of Skull Base Neoplasms, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Endonasal endoscopic approach to the skull base has been expanded in the last several years owing to advances in the radiological aspect that provided a better evaluation of the lesions and the surrounding structures, technological advances that include angled endoscope, development of high-resolution cameras, high… Read more about this study

Who is it for?
Any age
Conditions the study is for
Skull Base Neoplasms
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Jan 2018to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: all patient will undergo endonasal cranio-endoscopic resection

Who may be able to join

  • All patients undergoing endonasal cranio-endoscopic resection

Who cannot join

  • Unfit patient for surgery.
  • Patient refusal to participate in this study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University

    Asyut, 71515

Other trials in Egypt

About this study

Endonasal endoscopic approach to the skull base has been expanded in the last several years owing to advances in the radiological aspect that provided a better evaluation of the lesions and the surrounding structures, technological advances that include angled endoscope, development of high-resolution cameras, high definition monitors and navigation systems and better anatomical experience. The endoscopic endonasal approach now provides access to frontal sinus to the second cervical vertebra in the sagittal plane and from the sella to the jugular foramen in the coronal plane. Endoscopic resection of large skull base tumors results in large defect for which repair is a challenge. Several factors besides the size of the defect should be considered during skull base repair as CSF leak, CSF pressure, history or need for future radiotherapy, lack of support and local tissue vascularity. The aim of this study is to Provide an algorithmic approach for skull base reconstruction after endonasal cranio-endoscopic resection using autologous grafts according to the extent of resection, skull base defect size, the presence of CSF leak, CSF pressure and local tissue vascular

Read the detailed description

Type of the study:

A prospective clinical study will be conducted in the period between January 2018 and January 2020.

Study Setting:

Otolaryngology Department, Alexandria University Hospital. Otolaryngology Department, Assiut University Hospital.

Study tools :

Preoperative evaluation:

  1. Personal history: age, sex, marital status, occupation, number of children, and endocrinal history in case pituitary tumors.
  2. Presentation: endocrine, visual, oculomotor and/or a headache.
  3. Therapeutic history.
  4. Past history: trans-sphenoidal surgery, trauma and nasal diseases and/or surgery.
  5. General examination: including gross features of Cushing's disease or acromegaly.
  6. Full ENT examination including assessment of the nasal cavity, nasal septum for deviation, perforation and/or adhesions) and nasal turbinates; including nasal endoscopic examination and dental assessment.
  7. Neurosurgical consultation.
  8. Ophthalmological assessment: visual acuity, visual field, fundus examination and color vision.
  9. Radiological assessment:
  10. MRI of the brain: A complete protocol including at least, T1- and T2-weighted images and T1-weighted post-contrast (gadolinium) images, in the three orthogonal planes at max 3 mm sections: for assessment of tumor site, size and extension, and involvement of large blood vessels and nerves.
  11. Multi-slice CT scan of the nose and paranasal sinuses (bone window, high resolution, with intravenous contrast, in the three orthogonal planes, with three-dimensional reconstruction and at maximum 3 mm sections): for assessment of nasal cavity abnormalities including the nasal septum, sinus pathology, type of sphenoid sinus pneumatization, etc.
  12. Assessment of the general condition of the patient:
  13. Complete blood count: to assess for anemia or other hematological abnormalities.
  14. Serum electrolytes: mainly sodium and potassium.
  15. Fasting and postprandial blood glucose level.
  16. ECG and echocardiography.

Operative techniques:

After cranio-endoscopic resection and complete removal of the lesion skull base defect will be repaired according to the following scheme (modified from Sigler et al) No leak →No repair or single layer Low-flow leak → Multilayer repair Autograft (fascia Lata, fat, bone, mucosa) High-flow leak →Multilayer repair Autograft (fascia Lata, fat, bone, mucosa)+ Intranasal vascularized flap.

Modifying factors (factors that indicate the need for a vascularized flap regardless of leak type): Cushing disease, morbid obesity, craniopharyngioma, meningioma, extended skull base approach, large defect, revision surgery, history of or future need for radiation treatment.

So repair technique after extensive dural and bony resection or high flow leak will include multiple layers of fascia lata with pieces of fatty tissue in between. After that, a nasoseptal flap (or other vascularized flap, e.g., posterior pedicled inferior turbinate, posterior pedicled middle turbinate, bipedicled anterior septal, anterior inferior turbinate) will be harvested and applied according to local vascularity.

Then a separator will be applied; to prevent future accidental dislodgement of grafts during Merocel® removal, followed by placement of a moderately inflated Foley balloon catheter; to support the reconstruction.

At the end of the procedure, when hemostasis will be achieved, irrigation will be performed to remove any bone residuals or blood clots from the choanae and the nasopharynx. Then, the middle turbinates will be gently repositioned medially. At last, nasal Merocel® (polyvinyl alcohol) sponges will be placed in the nasal cavity on either side and hydrated with saline to expand.

Repair of low flow leak will be the same as the previous technique with the replacement of the vascularized flap with free mucosal graft and no need for Foley catheter.

Early postoperative management:

For the next twenty-four hours, the patient will be monitored in the intensive care unit, particularly for diabetes insipidus (after pituitary surgery), visual deterioration, any CSF leak, manifestations of meningitis or any hemorrhage.

Inspection for CSF leak will be a part of the routine evaluation of every patient, both in the recovery room and in the days after surgery. If persistent CSF leak became evident, a lumbar drainage was tried before re-exploration under general anesthesia. Analgesics will be routinely prescribed. Prophylaxis against postoperative nausea and vomiting will be achieved by an intraoperative intravenous administration of a single dose of an antiemetic, ondansetron 4 mg, as well as a throat pack to prevent intraoperative bleeding from draining into the stomach.

An intravenous third-generation cephalosporin will be started with anesthesia induction and continued until removal of the nasal packing. Then, patients will be kept on a five days course of an oral antibiotic; for safety.

Nasal packs will be removed on the third or fifth postoperative day. Then, the patient will be examined under endoscopic guidance.

Follow up:

  1. Otorhinolaryngologic assessment: The first office visit will be scheduled after a week following the surgery. After application of topical anesthesia (lidocaine 10%), any blood clots will be endoscopically removed and any synechiae will be released. The examination will be for any bleeding or CSF leakage. The patient will be seen on a weekly basis for the first three weeks and then every three weeks for the next two appointments. Healing usually occurs three to six weeks. Further appointments will be scheduled as necessary II. Neuro-radiological assessment: Early MRI will be obtained on the first or second postoperative day to assess the extent of resection, the location of the fat graft if one is present, and the presence of any hematoma. Serial imaging was done after six months and then annually.

III. Endocrinal assessment: in case of hypophysectomy. IV. Ophthalmological assessment: serial visual field, visual acuity, and fundus examinations will be done for every patient, especially those with a pre-operative visual loss.

Keywords
skull base reconstrction
Medical subject headings
Skull Base Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Head CT scan

    bone window axial, coronal and sagittal cuts to measure preoperative skull base defect size

    Measured: within 1month preoperative

  2. brain MRI: with and without contrast

    Coronal, axial and sagittal MRI in T1 and T2 signals measures postoperative tumor, to assess the repaired defect after the surgery

    Measured: within1 week post operative

  3. brain MRI: with and without contrast

    Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery

    Measured: 3 monthes post operative

  4. brain MRI: with and without contrast

    Coronal, axial and sagittal MRI in T1 and T2 signals to assess the repaired defect after the surgery, recurrence of tumor

    Measured: 6monthes postoperative

Secondary outcomes (6)
  1. estimation of incidence of sinonasal, orbital &/or intracranial complications

    identification of possible complication that will occur during resection of skull base and removal of tumors

    Measured: within 90 days following surgery

  2. the incidence of CSF leakage

    history of CSF leakage confirmed by endoscopic examination

    Measured: within 90 days postoperative

  3. CSF leakage related surgical intervention

    second surgical intervention to explore the grafted defect

    Measured: within 90 days postoperative

  4. Endonasal endoscopic evaluation of the grafted defect

    using 4 mm 0-degree endoscope to measure graft condition and visualize any CSF fistula

    Measured: within 1 month postoperative, 3monthes postoperative

  5. Brain MRI: with and without contrast

    Coronal, axial and sagittal MRI in T1 and T2 signals measures preoperative tumor size

    Measured: within 1 month preoperative

  6. type of pathology

    identification of the type of the pathology

    Measured: within 1 week post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2019 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448614
Sponsor's protocol ID
skull base reconstruction
Status last verified
Feb 2018
First submitted
6 Jan 2018
Last updated
28 Feb 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kassam A, Snyderman CH, Mintz A, Gardner P, Carrau RL. Expanded endonasal approach: the rostrocaudal axis. Part I. Crista galli to the sella turcica. Neurosurg Focus. 2005 Jul 15;19(1):E3.

    PubMed 16078817
  • Kassam A, Snyderman CH, Mintz A, Gardner P, Carrau RL. Expanded endonasal approach: the rostrocaudal axis. Part II. Posterior clinoids to the foramen magnum. Neurosurg Focus. 2005 Jul 15;19(1):E4.

    PubMed 16078818
  • Kassam AB, Gardner P, Snyderman C, Mintz A, Carrau R. Expanded endonasal approach: fully endoscopic, completely transnasal approach to the middle third of the clivus, petrous bone, middle cranial fossa, and infratemporal fossa. Neurosurg Focus. 2005 Jul 15;19(1):E6.

    PubMed 16078820
  • Kassam A, Carrau RL, Snyderman CH, Gardner P, Mintz A. Evolution of reconstructive techniques following endoscopic expanded endonasal approaches. Neurosurg Focus. 2005 Jul 15;19(1):E8.

    PubMed 16078822
  • Snyderman CH, Kassam AB, Carrau R, Mintz A. Endoscopic Reconstruction of Cranial Base Defects following Endonasal Skull Base Surgery. Skull Base. 2007 Feb;17(1):73-8. doi: 10.1055/s-2006-959337.

    PubMed 17603646
  • Sigler AC, D'Anza B, Lobo BC, Woodard TD, Recinos PF, Sindwani R. Endoscopic Skull Base Reconstruction: An Evolution of Materials and Methods. Otolaryngol Clin North Am. 2017 Jun;50(3):643-653. doi: 10.1016/j.otc.2017.01.015. Epub 2017 Mar 31.

    PubMed 28372814
  • Villaret AB, Schreiber A, Battaglia P, Bignami M. Endoscopy-assisted iliotibial tract harvesting for skull base reconstruction: feasibility on a cadaveric model. Skull Base. 2011 May;21(3):185-8. doi: 10.1055/s-0031-1275260.

    PubMed 22451823
  • Zanation AM, Thorp BD, Parmar P, Harvey RJ. Reconstructive options for endoscopic skull base surgery. Otolaryngol Clin North Am. 2011 Oct;44(5):1201-22. doi: 10.1016/j.otc.2011.06.016.

    PubMed 21978902
  • Hadad G, Bassagasteguy L, Carrau RL, Mataza JC, Kassam A, Snyderman CH, Mintz A. A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap. Laryngoscope. 2006 Oct;116(10):1882-6. doi: 10.1097/01.mlg.0000234933.37779.e4.

    PubMed 17003708
  • El-Sayed IH, Roediger FC, Goldberg AN, Parsa AT, McDermott MW. Endoscopic reconstruction of skull base defects with the nasal septal flap. Skull Base. 2008 Nov;18(6):385-94. doi: 10.1055/s-0028-1096202.

    PubMed 19412408

Questions about this trial

What is this clinical trial studying?

An observational study of Skull Base Neoplasms, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Head CT scan (time frame: within 1month preoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448614, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.

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