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Status unknownNCT02718365Updated Oct 12, 2020

Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC

An interventional study of Wedge resection and Segmentectomy in Lung Neoplasms and Surgery, sponsored by West China Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-12.

Sponsored by West China Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,382
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.

Read the detailed description

  1. Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial. The following rules will be strictly applied:

    1. The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted.
    2. If the Eligibility Application Form is incomplete, it must be returned to be completed; otherwise, it will not be accepted.
    3. After being approved by the Research Committee, the case will be assigned a number (Baseline Number, BN) and an Eligibility Confirmation Notice will be sent to the applicant.
    4. After each research participating center receives the Eligibility Confirmation Notice, the research assistant of each center is responsible for the custody and documentation.
    5. Once being selected for registration, the content of the Eligibility Application Form will be input into the database and the case's eligibility is not allowed to be cancelled, that is, the relevant information cannot be deleted from the database, unless the patient declines the information to be used in this study.
    6. The data center will not accept any duplicated applications for any single case. If this happens, the first registered data will be used (i.e., the first time BN).
    7. In cases of duplicated applications or registration errors, the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation.
  2. Qualification of the responsible surgeons who participate in this study: the responsible surgeons who participate in this study shall meet the following qualifications: 1) at least have completed 20 cases of VATS segmentectomy; and 2) have passed the blind review of his/her video records of the surgery.
  3. Criteria for confirming operation quality: for the case to be included in the analysis, the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures.
  4. Rules for handling the excluded patients identified intraoperatively: if the responsible surgeon finds that the patient in operation meets the exclusion criteria, the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol.
02

Conditions studied

  • Lung Neoplasms
  • Surgery

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Keywords

  • Lung Neoplasms
  • Surgery
  • VATS
  • GGO
  • GGN
  • Segmentectomy
  • Wedge Resection
  • Prognosis
03

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 1,382 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:

    • Lung cancer is suspected.
    • Lesion size is more than 5 mm but equal to or less than 20 mm.
    • Consolidation/tumor (C/T) ratio is equal to or less than 0.25.
    • The center of the tumor is located in the outer third of the lung field.
    • Preoperative TSCT estimates a surgical margin of more than1.5 cm or the tumor's diameter.
  2. Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
  3. R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
  4. Aged 18 to 75 years old.
  5. No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
  6. Preoperative FEV1.0>=1.0 L.
  7. Performance status of ECOG 0 or 1.
  8. Preoperative ASA scoring (American society of anesthesiology) class I -III.
  9. Sufficient organ functions.
  10. The patient agrees to participate in the trial and signs the informed consent form.

Exclusion criteria

Exclusion criteria:

  1. Quit smoking \<2 weeks.
  2. Preoperative FEV1 \< 50% of the expected value.
  3. Mediastinal lymph node metastasis confirmed by biopsy.
  4. Pregnant or lactating women.
  5. Serious mental illness.
  6. With other malignant disease history within 5 years.
  7. With the history of unstable angina or myocardial infarction within 6 months.
  8. With the history of cerebral infarction or cerebral hemorrhage within 6 months.
  9. With the history of sustained systemic corticosteroid therapy within 1 month.
  10. The patient requires simultaneous surgical treatment of other diseases.
  11. TSCT shows that the lesion is located in the right middle lobe.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,382 participants (estimated)

Study arms

  • Experimental
    Group A

    Wedge resection

    Procedure: Wedge resection

  • Active comparator
    Group B

    Segmentectomy

    Procedure: Segmentectomy

Interventions

  • ProcedureWedge resection

    A wedge resection is the surgical removal of the lung tumor with a small portion of the lung that surrounds the tumor. Hilar and mediastinal lymph nodes should be resected or sampled.

  • ProcedureSegmentectomy

    A segmentectomy removes a segment of a lung lobe anatomically, or inclusion of a portion of adjacent segment, but does not remove the whole lung lobe. Hilar and mediastinal lymph nodes should be resected or sampled.

06

What researchers measure

Primary outcomes

  1. 5-year Progression-Free-Survival

    Time frame: From date of the recruitment, assessed up to 60 months

Secondary outcomes

  1. 3-year Progression-Free-Survival

    Time frame: From date of the recruitment, assessed up to 36 months

  2. 5-year overall survival

    Time frame: From date of the recruitment, assessed up to 60 months

  3. Pulmonary function in the first year after surgery

    Time frame: From date of the 1 month\ 3 months\ 6 months\ 12 months after surgery in every recruited patient

  4. 30-day Morbidity and mortality rates

    Time frame: From date of the recruitment, assessed up to 30 days

  5. 10-year overall survival

    Time frame: From date of the recruitment, assessed up to 120 months

07

Study locations

1 of 1 sites recruiting
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
    • Hu Liao, MD · Contact
    • Lunxu Liu, MD, PhD · Principal investigator
    • Hu Liao, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PubMed 21714641 ↗
  • Zhang Y, Sun Y, Wang R, Ye T, Zhang Y, Chen H. Meta-analysis of lobectomy, segmentectomy, and wedge resection for stage I non-small cell lung cancer. J Surg Oncol. 2015 Mar;111(3):334-40. doi: 10.1002/jso.23800. Epub 2014 Oct 16. PubMed 25322915 ↗
  • Hida Y, Teramura K, Muto J, Ohtaka K, Hase R, Nakada R, Watanabe Y, Matsui Y, Kaga K. [Indication of limited pulmonary resection for small-sized lung cancer based on preoperative clinical data]. Kyobu Geka. 2012 Jan;65(1):52-7. Japanese. PubMed 22314158 ↗
  • Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094. PubMed 24551879 ↗
  • Cho JH, Choi YS, Kim J, Kim HK, Zo JI, Shim YM. Long-term outcomes of wedge resection for pulmonary ground-glass opacity nodules. Ann Thorac Surg. 2015 Jan;99(1):218-22. doi: 10.1016/j.athoracsur.2014.07.068. Epub 2014 Nov 15. PubMed 25440277 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02718365
Lead sponsor
West China Hospital
Responsible party
Lunxu Liu (Professor and Chair of Department of Thoracic Surgery, West China Hospital) — Principal investigator
First posted
Mar 24, 2016
Start date
Dec 7, 2017
Primary completion
Dec 2022 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 12, 2020

Study contacts

Hu Liao, M.D.
Contact
liaotiger_198653@163.com
+86 28 85422494
Liyan Chen, M.Sc.
Contact
lilianchan7786@126.com
+86 28 85422494
Lunxu Liu, M.D., Ph.D.
principal investigator · Department of Thoracic Surgery, West China Hospital, Sichuan University

Oversight

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

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