CClinicalTrials.gg
Status unknownNCT02817048Updated Jun 29, 2016

Tubeless VATS for Peripheral Lung Nodule

An interventional study of chest tube and VATS without chest tube placement in Solitary Pulmonary Nodule, sponsored by National Taiwan University Hospital. Status unknown. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study summary

Chest tube placement after thoracoscopy surgery had been generally accepted as routine procedure for removal of the residual intrapleural fluid and air, however, it would cause post-operative pain, prohibit ambulation after surgery, and prolong the hospital stay. According to the recent studies, omission of chest tube placement after minor thoracoscopic procedures (such as pulmonary wedge resection) had been safe and feasible, and it also reduced the post-operative pain and shortened the hospital stay. We will conduct a prospective randomized trial in National Taiwan University Hospital.

Read the detailed description

We will enroll 100 patients with peripheral lung nodule who will be randomly assigned to no chest tube placement (tubeless group) or chest tube placement (control group) after thoracoscopic wedge resection with out without lymph adenectomy. The primary endpoints are to compare the post-operative hospital stay and post-operative pain sale between the two groups. The secondary endpoints are to compare the intercostal neuralgia and wound satisfaction one month after surgery between the two groups.

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Conditions studied

  • Solitary Pulmonary Nodule
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In context

Multiple Pulmonary Nodules

188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.

This study's planned enrollment of 100 is above the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • CT revealed peripheral lung nodule, with both size and depth less than 2 cm
  • Aged 20 to 80 years

Exclusion criteria

Exclusion Criteria:

  • Patients with ventilatory defect
  • Previous ipsilateral thoracic surgery
  • Bleeding tendency or anticoagulant use
  • Comorbidity including congestive heart failure, liver cirrhosis, chronic renal disease
  • Pregnancy or breast feeding
  • Immunocompromised or long-term steroid use
  • Severe infected patient
  • Patient who can not sign permit
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Tubeless

    Interventions: VATS without chest tube placement

    Procedure: VATS without chest tube placement

  • Active comparator
    Chest tube

    VATS with chest tube placement

    Device: chest tube · Procedure: VATS with chest tube placement

Interventions

  • Devicechest tube
  • ProcedureVATS without chest tube placement

    Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)

  • ProcedureVATS with chest tube placement
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What researchers measure

Primary outcomes

  1. Postoperative hospital stay

    Time frame: 1 week

Secondary outcomes

  1. Postoperative pain score

    Time frame: 1 week

  2. Postoperative intercostal neuralgia

    Time frame: 1 month

  3. Postoperative wound satisfaction

    Time frame: 1 month

Other outcomes

  1. Hospital cost

    Time frame: 1 week

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083. PubMed 15511470 ↗
  • Rocco G, Romano V, Accardo R, Tempesta A, La Manna C, La Rocca A, Martucci N, D' Aiuto M, Polimeno E. Awake single-access (uniportal) video-assisted thoracoscopic surgery for peripheral pulmonary nodules in a complete ambulatory setting. Ann Thorac Surg. 2010 May;89(5):1625-7. doi: 10.1016/j.athoracsur.2010.01.087. PubMed 20417792 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02817048
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 29, 2016
Start date
Jun 2016
Primary completion
Jun 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Jun 29, 2016

Study contacts

Jin-Shing Chen, MD, PhD
Contact
chenjs@ntu.edu.tw
886-2-23123456 ext. 65178
Jin-Shing Chen, MD, PhD
study director · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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