Medical Thoracoscopy for Diagnosing Unexplained Pleural E... | NCT06275178

Studies
Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study

NCT06275178

Sponsor

China-Japan Friendship Hospital

Status

Unknown status

Last Update Posted

Feb 23, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Pleural Effusion
Pleural Effusion, Malignant
Fibrinous Pleuritis

Interventions

Medical thoracoscopy

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

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2024Estimated

Primary Completion Date

Dec 24, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 17, 2024

First Submission Date that Met QC Criteria

Feb 17, 2024

First Posted Date

Feb 23, 2024Actual

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

Feb 17, 2024

Last Update Posted Date

Feb 23, 2024Actual

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

This study is a national multicenter retrospective study. Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy for patients in recent 10 years were retrospectively collected from multiple centers to understand the proportion and final etiological composition of pleural effusion in China.

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical thoracoscopy	Procedure	The included particpants are the patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of fibrinous pleurisy in Chinese population	The proportion of fibrinous pleurisy in Chinese population	December 31, 2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy

Exclusion Criteria:

Patients who cannot obtain a final diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with pleural effusion who underwent medical thoracoscopy were included in the study. Patients who could not obtain a final diagnosis were excluded from the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gang Hou, MD	Contact	010-84205729		hougangcmu@163.com
Mingming Deng, PhD	Contact	+86 18801336854		isdeng@163.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010996	Pleural Effusion
D016066	Pleural Effusion, Malignant

Ancestor Terms

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases
D010997	Pleural Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided