- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406442
Transpterygoid Approaches
Endoscopic Endonasal Transpterygoid Approaches
To identify:
- The most frequent pathologies affecting pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx that can be treated by endonasal endoscopic transptergoid approaches, the most common presenting manifestations and indication of surgery.
- The different techniques and feasibility of different endonasal endoscopic transpterygoid approaches and the frequency of utilization of approach.
- Try to establish a protocol for post-operative care and management of complications.
- Obtain sufficient surgical experience in endonasal endoscopic transpterygoid surgery to establish endonasal endoscopic skull-base surgery in Assiut University Hospital.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Skull base surgery has undergone dramatic advances. During early stages, the endoscopic approaches were limited by the resultant skull base defects .
Access to the pterygopalatine fossa (PPF) is a surgical challenge due to its deep location in the mid-third of the face and its complex array of vascular and neural structures. An important aspect of the PPF is its topographical relation to the orbit and cranial cavity.
The philosophy behind the transpterygoid approach centers on the maxillary sinus as the primary corridor, displaces the contents of the PPF and removes the pterygoid process partially or completely to reach to the lateral extent of the endonasal technique.
The endoscopic endonasal transpterygoid approaches classified into five types. Type A involves thinning of the pterygoid process to gain access to PPF. Type B involves removal of the medial and anterior aspect of the base of the pterygoid process to access the lateral recess of the sphenoid sinus. Type C involves dissecting the vidian nerve to identify the petrous ICA and removing the base of the pterygoid plates to reach the petrous apex, Meckel's cave, or cavernous sinus. Type D requires a variable removal of the pterygoid plates to access the infratemporal fossa. Type E requires removal of part or even the entire pterygoid process, and the medial third of the Eustachian tube to provide exposure of the lateral nasopharynx.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed El-rahman mohamed azzam
- Phone Number: 00201099978990
- Email: drahmedazzam89@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Any patient with lesions affecting pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx that can be treated by endonasal endoscopic transptergoid approaches.
Exclusion Criteria:
- Medically unfit patients for surgery
- In case of distant metastasis in tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: patients
The patient who have lesions affecting pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx and can be treated by endonasal endoscopic transptergoid approaches
|
All patients will be operated by transpterygoid approaches which is classified into 5 major types.Type A involves thinning of the pterygoid process to access to Pterygopalatine fossa.
Type B involves the removal of the medial and anterior aspect of the base of the pterygoid process to access the lateral recess of sphenoid sinus.
Type C involves removing the base of the pterygoid plates to reach the petrous apex, Meckel's cave, or cavernous sinus.
Type D requires removal of the pterygoid plates to access the infratemporal fossa.
Type E requires the removal of the medial pterygoid plate or the entire pterygoid process, and the medial third of the Eustachian tube to acessof the lateral nasopharynx
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type of the pathology
Time Frame: 1 week
|
Identification of the type lesion will be made.
|
1 week
|
Frequency of residual mass
Time Frame: 1 week
|
Early MRI will be obtained after a week to asses the extent of resection and search if there is residual mass.
|
1 week
|
Frequency of recurrence
Time Frame: 6 months
|
Imaging will be done in six months period to search for any recurrence.
|
6 months
|
Frequency of complication
Time Frame: 1 month
|
Post-operative follow up of the patients will be done to identify the frequency of complication either rhinogenic as bleeding , synechiae, csf leakage or orbital complication as proptosis, visual affection or intracranial complication as meningitis.
|
1 month
|
Operation time
Time Frame: intraoperative
|
The time of the operation will be calculated in this endoscopic approach comparing to traditional open technique.
|
intraoperative
|
Intraoperative bleeding
Time Frame: Intraoperative
|
The amount of intraoperative bleeding and the ability to control it.
|
Intraoperative
|
Surgical field exposure
Time Frame: Intraoperative
|
The possibility of the approach to reach lesions affecting deep area in the skull as pterygopalatine fossa, lateral recess of the sphenoid sinus, petrous apex, Meckel's cave, cavernous sinus, infratemporal fossa and lateral nasopharynx.
|
Intraoperative
|
Post-operative stay
Time Frame: 2 weeks
|
post-operative stay of the patient in hospital.
|
2 weeks
|
mortality rate
Time Frame: 1 year
|
any deaths
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohammed Shaker Abd-Elaal, MD, Assiut University
- Principal Investigator: Hossam El-din Mahmoud El-Bosraty, MD, Cairo University
- Study Director: Mohamed Modather Abd El-Naam, MD, PHD, Assiut University
Publications and helpful links
General Publications
- Chibbaro S, Cornelius JF, Froelich S, Tigan L, Kehrli P, Debry C, Romano A, Herman P, George B, Bresson D. Endoscopic endonasal approach in the management of skull base chordomas--clinical experience on a large series, technique, outcome, and pitfalls. Neurosurg Rev. 2014 Apr;37(2):217-24; discussion 224-5. doi: 10.1007/s10143-013-0503-9. Epub 2013 Nov 19.
- Choi J, Park HS. The clinical anatomy of the maxillary artery in the pterygopalatine fossa. J Oral Maxillofac Surg. 2003 Jan;61(1):72-8. doi: 10.1053/joms.2003.50012.
- Kasemsiri P, Solares CA, Carrau RL, Prosser JD, Prevedello DM, Otto BA, Old M, Kassam AB. Endoscopic endonasal transpterygoid approaches: anatomical landmarks for planning the surgical corridor. Laryngoscope. 2013 Apr;123(4):811-5. doi: 10.1002/lary.23697.
- Hofstetter CP, Singh A, Anand VK, Kacker A, Schwartz TH. The endoscopic, endonasal, transmaxillary transpterygoid approach to the pterygopalatine fossa, infratemporal fossa, petrous apex, and the Meckel cave. J Neurosurg. 2010 Nov;113(5):967-74. doi: 10.3171/2009.10.JNS09157. Epub 2009 Nov 20.
- Kassam AB, Prevedello DM, Carrau RL, Snyderman CH, Thomas A, Gardner P, Zanation A, Duz B, Stefko ST, Byers K, Horowitz MB. Endoscopic endonasal skull base surgery: analysis of complications in the authors' initial 800 patients. J Neurosurg. 2011 Jun;114(6):1544-68. doi: 10.3171/2010.10.JNS09406. Epub 2010 Dec 17.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- transpterygoid approaches
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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