Head and Neck Paragangliomas: A 16-year Experience of a U... | NCT05942482

Studies
Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey

NCT05942482

Sponsor

Pamukkale University

Status

Completed

Last Update Posted

Sep 15, 2023Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Head and Neck Paraganglioma

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2023Actual

Primary Completion Date

Jul 5, 2023Actual

Completion Date

Jul 5, 2023Actual

First Submitted Date

Jun 30, 2023

First Submission Date that Met QC Criteria

Jul 11, 2023

First Posted Date

Jul 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2023

Last Update Posted Date

Sep 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.

Detailed Description

39 patients were selected and analyzed retrospectively. Demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.Preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. In such cases, combination therapy alongside surgery may improve treatment outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative recurrence	Incidence of recurrences after the surgery	may 2023-june 2023
Postoperative nerve paralysis	Incidence of facial, vagus, hypoglossus, accesorius nerve paralysis after surgery	may 2023-june 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histopathological diagnosis of carotid paraganglioma
Histopathological diagnosis of vagal paraganglioma
Histopathological diagnosis of jugular paraganglioma
Histopathological diagnosis of tympanic paraganglioma

Exclusion Criteria:

-Inadequate information in files

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent head and neck surgeries at Pamukkale University Hospital between 2007 and 2023, resulting in a histopathological diagnosis of paraganglioma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fazıl N Ardıç, MD	Pamukkale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University		Denizli		20070	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010235	Paraganglioma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided