NCT04690790

Brief Summary

Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

January 23, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

December 28, 2020

Last Update Submit

January 23, 2021

Conditions

Video-assisted Thoracic SurgeryPulmonary Nodules

Keywords

Video-assisted thoracic surgeryThoracoscopyLocalizationPulmonary nodules

Outcome Measures

Primary Outcomes (1)

  • Nodule detection

    Whether the nodule could be detected by conventional visualization or palpation

    During surgery

Interventions

ThoracoscopyPROCEDURE

Patients who are indicated for thoracoscopic nodulectomy.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients indicated for thoracoscopic nodulectomy

You may qualify if:

  • Age ≧ 20 years
  • Lung nodule size ≦2cm on the pre-operative computed tomography (CT)
  • Nodulectomy is performed under thoracoscopy

You may not qualify if:

  • Age \< 20 years
  • Lung nodule size \> 2cm on CT or in the final pathology report
  • Open surgery for nodulectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-DA Hospital

Kaohsiung City, 824, Taiwan

RECRUITING

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Lung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Ming-Wei Kao, M.D., M.S.

    E-DA Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Wei Kao, M.D., M.S.

CONTACT

+886-7-6150011ed107576@edah.org.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
president

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

January 23, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

TW(1)