Clinical Evaluation of Fenestration Decompression Combine... | NCT04987515

Studies
Clinical Evaluation of Fenestration Decompression Combined With Secondary Curettage for Ameloblastoma of the Jaw: Retrospective Radiographic Analysis

NCT04987515

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Completed

Last Update Posted

Nov 22, 2021Actual

Enrollment

233Actual

Phase

Not provided

Conditions

Cystic Cavity Area Reduction Efficiency
the Recurrence of the Tumor

Interventions

fenestration decompression combined with secondary curettage

Countries

Not provided

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

Status Module

Record Verification Date

Nov 2021

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

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 3, 2021Actual

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

Nov 14, 2021

Last Update Posted Date

Nov 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hejie, associate chief physician, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Objectives: To investigate the outcomes of fenestration decompression combined with secondary curettage (FDSC) in the surgical treatment of jaw ameloblastoma.

Methods: Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: FDSC group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups. A total of 233 eligible patients were selected for provisional screening, including 145 patients with MA, and 88 patients with UA.

Detailed Description

Not provided

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

233Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fenestration decompression combined with secondary curettage (FDSC)		Design of the opening window reasonably；Making cyst plug；secondary curettage	Procedure: fenestration decompression combined with secondary curettage
local curettage (LC)		The tumor was removed by local curettage only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fenestration decompression combined with secondary curettage	Procedure	First，fenestration decompression was performed. then, patients return every 3 months for follow up. If the cystic cavity area was gradually reduced after one year of follow-up, patients should be considered for secondary curettage surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cystic cavity area reduction efficiency	(good effect case number + moderate effect case number)/total case number	3 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Tumor recurrence rate	the recurrence case number/total case number	3 years after surgery

Other Outcomes

Measure	Description	Time Frame
malignant transformation rate	malignant transformation case number/total case number	3 years after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Medical records of patients who were diagnosed with multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital of Shanghai JiaoTong University Medical College.

Exclusion Criteria:

followed up less than 3 years
For FDSC group, fenestration decompression failed
recurrent ameloblastoma
received other type of surgery;

Accepts Healthy Volunteers

Yes

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

Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: fenestration decompression combined with secondary curettage (FDSC) group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.