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CompletedNCT03439696UNeedUpdated Feb 25, 2021

Needlescopic-assisted Uniportal vs Uniportal VATS

An interventional study of Thoracoscopic surgery in Lung Cancer, Lung Cancer Metastatic and Bullous Disease Lung, sponsored by IRB of NTUH Hsin-Chu Branch. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by IRB of NTUH Hsin-Chu Branch · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 195 studies in Lung Neoplasms with a site in Taiwan — 56 open to participants now, 77 under way, 19 of them phase 3. Lung Neoplasms · Taiwan.

Enrollment
96th of 146
110 · median 190
Started
2018
with 7 others
No phase
37 of 195
10 open now
Registered
85th of 195
by date

Among the 195 studies in Lung Neoplasms with a site in Taiwan, this one is the 96th largest by enrollment of the 146 interventional ones, is one of 8 that started in 2018, is one of 37 with no phase, and was the 85th registered.

By phase

195 studies; the count open now beside each. This study's row is marked.

Observational49 · 18 open
No phasethis study37 · 10 open
Phase 337 · 10 open
Phase 233 · 9 open
Phase 117 · 1 open
Phase 1/213 · 4 open
Phase 2/35 · 2 open
Phase 44 · 2 open

By the year they started

First in 2002; this study’s year is marked. 8 started in 2018.

Size and results

Median enrollment 190 across the 146 interventional studies, 139 across the 49 observational. Of the 84 that completed or were terminated, 39 (46%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 195 studies in Lung Neoplasms with a site in Taiwan, or all of them as a file.
02

Study summary

The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.

03

Conditions studied

  • Lung Cancer
  • Lung Cancer Metastatic
  • Bullous Disease Lung
  • Nodule Solitary Pulmonary
  • Mediastinal Tumor

Keywords

  • Thoracoscopy
  • VATS
  • Needlescopy
  • Uniportal
04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion criteria

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Needlescopic-assisted

    Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.

    Procedure: Thoracoscopic surgery

  • Active comparator
    Uniportal

    Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

    Procedure: Thoracoscopic surgery

Interventions

  • ProcedureThoracoscopic surgery

    Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

06

What researchers measure

Primary outcomes

  1. Pain scale POD 3

    Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

    Time frame: 3 days

  2. Pain scale POD 5

    Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

    Time frame: 5 days

  3. Hospital stay

    Post-operative hospital stay

    Time frame: 14 days

  4. Post-operative 3 month neuralgia

    Out patient documented using PainDETECT questionnaire (PD-Q)

    Time frame: 3 months

  5. Post-operative 6 month neuralgia

    Out patient documented using PainDETECT questionnaire (PD-Q)

    Time frame: 6 months

Secondary outcomes

  1. Cost

    Total hospital cost

    Time frame: 14 days

  2. Surgical time

    Time spend in surgery

    Time frame: 1 day

  3. Surgical bleeding

    Blood loss during operation

    Time frame: 1 day

  4. Opioid using dosage

    Total opioid equivalent dose used during post-operative course

    Time frame: 14 days

07

Study locations

1 site
  • National Taiwan University Hospital, Hsin-Chu Branch
    Taipei, Hsin-Chu County 30059, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Dec 2018, 9 months.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 9 months is below that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2018
First posted
Feb 20, 2018
StartActual
Feb 22, 2018
Primary completionActual
Dec 12, 2018
CompletionActual
Apr 30, 2019
Last update
Feb 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03439696
Lead sponsor
IRB of NTUH Hsin-Chu Branch
Responsible party
IRB of NTUH Hsin-Chu Branch (National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch) — Sponsor-investigator
First posted
Feb 20, 2018
Start date
Feb 22, 2018
Primary completion
Dec 12, 2018
Completion
Apr 30, 2019
Last update
Feb 25, 2021

Study contacts

Chiu-kuei Nien
principal investigator · National Taiwan University Hospital Hsinchu Branch

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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