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Status unknownNCT03185754Updated Nov 5, 2020

Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer

An interventional study of Sublobar resection and lobectomy in Lung Cancer and Surgery, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-05.

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

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
30 Years to 80 Years
Sex
All
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Study summary

A multi-center prospective randomized trial in Taiwan to investigate whether sublobar resection, as compared to lobectomy, can offer equivalent clinical results to treat early non-small cell lung cancer.

Read the detailed description

Background: Lung cancer has become an important disease threatening the public health world-wide. Surgical resection is the standard of care for treating non-small cell lung cancer in early stage. For decades, pulmonary lobectomy with lymph node dissection remains the gold standard of surgical approach. Pulmonary sublobar resection with pulmonary wedge resection or segmentectomy was reserved for the patients with high surgical risk, who were unsuitable for radical surgical resection. Pulmonary sublobar resection for tumor less than three centimeter was demonstrated to associated with higher risk of tumor recurrence or worsening survival outcome as compared to that done by lobectomy. 1 However, these data was which was not necessarily applicable to patients with early lung cancer with tumor of smaller size which was more frequently detected with the health screening test by CT scan in general population now. Although several retrospective studies has demonstrated that sublobar resection can offer a similar survival outcome after surgery as compared to that done by standard lobectomy once the tumor was smaller than two centimeter 2, there is still no consensus about the role of sublobar resection for these small early lung cancer. In general, there are several factors associating with higher risk of local recurrence which should be avoided for sublobar resection, including resection margin less than 2 cm or less than the diameter of the tumor itself 3, more obvious speculation in CT image or central location which makes it difficult to obtain adequate resection margin 4,5. Therefore, sublobar resection should be applied to the patients of early lung cancer when two cm of resection margin is achievable. The central location , obvious tumor infiltration in image study or presence of lymph node metastasis should be also avoided.

Patients and methods: The study will include surgical patients from six medical centers in Taiwan. All of the patients will receive complete study about the surgical risk and tumor staging before surgery. The patients will receive general anesthesia and pulmonary resection as the standard procedures including division of pulmonary vessels and bronchus. Either VATS (Video-assisted thoracoscopic surgery) or open surgery is acceptable for the surgical approaches. The patients will be randomly assigned to lobectomy and sublobar resection groups. Two cm of resection margin will be obtained in each patient in the sublobar resection group by wedge resection or segmentectomy. Standard lymph node dissection including the pulmonary hilum and mediastinum will be done in both groups of patients. For suspicious of pulmonary hilum or mediastinal lymph node metastasis, frozen pathological examination will be requested.

Post operative care and follow-up: The patients will be transferred to intensive care unit or surgical recovery room after surgery. Medication for pain control and postoperative rehabilitation education will be given to each patient after surgery. The chest tube will be removed after daily discharge less than 100 to 200 ml without air-leakage, adequate lung expansion noted in chest X ray imaging. The patient will be discharged from the hospital one or two days after removal of the chest tube. Whole body bone scan and CT scan will be given in every 6 months at least after surgery for postoperative follow-up.

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Conditions studied

  • Lung Cancer
  • Surgery

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Keywords

  • lung cancer
  • surgery
  • lobectomy
  • sublobar resection
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 600 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms 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
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Early non-small cell lung cancer (stage Ia) with diameter of two centimeters or less.
  • Tumor locating at the peripheral lung parenchyma (outer one third in CT imaging).
  • No suspected hilar or mediastinal lymph nodes metastasis in the CT or PET imaging study.

Exclusion criteria

Exclusion criteria:

  • Tumor diameter more than 2 centimeter
  • Hilar or mediastinal lymphnode metastasis by the cancer.
  • Patients received previous surgery in the ipsi-lateral lung
  • Lung tumor locating in the central lung parenchyma unable to obtain curative resection by sublobar resection.
  • Patients with poor cardiopulmonary function unsuitable for receiving surgical resection.
  • Patients who have multiple lung cancer or other suspicious lesion in the lung.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    early phase lung cancer

    sublobar resection and lobectomy

    Procedure: Sublobar resection · Procedure: lobectomy

Interventions

  • ProcedureSublobar resection

    Sublobar resection

  • Procedurelobectomy

    lobectomy

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What researchers measure

Primary outcomes

  1. Disease-free survival (DFS)

    The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

    Time frame: 5 years

Secondary outcomes

  1. post-operative complication

    defined as any deviation from the normal postoperative course

    Time frame: 3 months

  2. Hospitalization time

    the time interval from the day of surgery to discharge

    Time frame: 3 months

  3. Chest tube duration

    the time interval from the day of surgery to the day of chest tube removal

    Time frame: 3 months

  4. post-operative pulmonary function

    the pulmonary function at 6, 12, and 24 months post-operation

    Time frame: 6, 12 and 24 months

Other outcomes

  1. pain score

    post-operative pain assessment during hospital stay

    Time frame: 1, 3, and 7 days

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Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Publications

  • Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995 Sep;60(3):615-22; discussion 622-3. doi: 10.1016/0003-4975(95)00537-u. PubMed 7677489 ↗
  • Sienel W, Dango S, Kirschbaum A, Cucuruz B, Horth W, Stremmel C, Passlick B. Sublobar resections in stage IA non-small cell lung cancer: segmentectomies result in significantly better cancer-related survival than wedge resections. Eur J Cardiothorac Surg. 2008 Apr;33(4):728-34. doi: 10.1016/j.ejcts.2007.12.048. Epub 2008 Feb 7. PubMed 18261918 ↗
  • Kodama K, Doi O, Higashiyama M, Yokouchi H. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg. 1997 Sep;114(3):347-53. doi: 10.1016/S0022-5223(97)70179-X. PubMed 9305186 ↗
  • Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001 Mar;71(3):956-60; discussion 961. doi: 10.1016/s0003-4975(00)02223-2. PubMed 11269480 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, 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
NCT03185754
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 14, 2017
Start date
Jun 12, 2013
Primary completion
Nov 15, 2020 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 5, 2020

Study contacts

Lee Jang-Ming
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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