Clinical trial NCT03406442: Transpterygoid Approaches
Official title: Endoscopic Endonasal Transpterygoid Approaches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transpterygoid Approaches
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To identify:

1. 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.
2. The different techniques and feasibility of different endonasal endoscopic transpterygoid approaches and the frequency of utilization of approach.
3. Try to establish a protocol for post-operative care and management of complications.
4. Obtain sufficient surgical experience in endonasal endoscopic transpterygoid surgery to establish endonasal endoscopic skull-base surgery in Assiut University Hospital.

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.

Eligibility criteria: 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:

1. Medically unfit patients for surgery
2. In case of distant metastasis in tumors

Primary outcomes:
measure: Type of the pathology
timeFrame: 1 week
measure: Frequency of residual mass
timeFrame: 1 week
measure: Frequency of recurrence
timeFrame: 6 months
measure: Frequency of complication
timeFrame: 1 month
measure: Operation time
timeFrame: intraoperative
measure: Intraoperative bleeding
timeFrame: Intraoperative
measure: Surgical field exposure
timeFrame: Intraoperative
measure: Post-operative stay
timeFrame: 2 weeks
measure: mortality rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohammed Shaker Abd-Elaal, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hossam El-din Mahmoud El-Bosraty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mohamed Modather Abd El-Naam, MD, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.