Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

April 6, 2026 updated by: Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Negative by Intraoperative Frozen Sections: A Prospective and Multi-center Randomized Controlled Trial Study

This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

At present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. Travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. However, there is still little evidence weather segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the non-inferiority in recurrence free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma (≤ 2 cm) not including micropapillary components.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
690

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Chest Hospital
        • Contact:
          • Ning Xu
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
          • Mingran Xie
    • Henan
      • Nanyang, Henan, China
        • Recruiting
        • Nanyang Central Hospital
        • Contact:
          • Xinwei Dong
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
          • Honggang Ke
      • Nantong, Jiangsu, China, 216002
        • Recruiting
        • The Sixth People's Hospital of Nantong
        • Contact:
          • Xuedong Zhang
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Hao Xu
      • Yancheng, Jiangsu, China
        • Recruiting
        • Yancheng First People's Hospital
        • Contact:
          • Jian Sun
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Public Health Clinical Center
        • Contact:
          • Feng Jin
        • Sub-Investigator:
          • Yunzeng Zhang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huadong Hospital
        • Contact:
          • Xiaoyong Shen
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Junqiang Fan
      • Huzhou, Zhejiang, China
        • Recruiting
        • Huzhou Central Hospital
        • Contact:
          • Qibin Shen
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo First Hospital
        • Contact:
          • Xinjian Li
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo No.2 Hospital
        • Contact:
          • Guofang Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged 20-79 years old, both male or female;
  • Tumor size <= 2cm on preoperative CT scan;
  • Peripheral solitary nodule or the associated lesion is MIA or less invasive lesion;
  • Preoperative CT indicated that the nodules were non-pure glass nodules (consolidation to tumor ratio >= 0.25);
  • Intraoperative frozen section confirmed invasive lung adenocarcinoma with micropapillary and solid subtype negative (<= 5%);
  • Intraoperative frozen section indicated the resection margins was free of tumor cells;
  • Lung function could withstand both lung segmentectomy and lobectomy (FEV1 > 1.5L or FEV1% >= 60%);
  • Eastern Cooperative Oncology Group, 0 to 2;
  • Volunteer to participate the trial and sign the informed consent, able to comply with the follow-up plan and other program requirements.

Exclusion Criteria:

  • Radiological pure ground glass nodules (consolidation to tumor ratio < 0.25);
  • The nodule is close to the lung hilus and is unable to perform segmentectomy;
  • Intraoperative frozen section confirmed with micropapillary and solid subtype positive (> 5%);
  • Intraoperative frozen section confirmed adenocarcinoma in situ and minimally invasive adenocarcinoma;
  • Preoperative imaging examination or EBUS indicated lymph node positive metastasis;
  • Preoperative imaging examination revealed distant metastasis;
  • Patients with severe damage to heart, liver and kidney function (grade 3 ~ 4, ALT and/or AST over 3 times the normal upper limit, Cr over the normal upper limit);
  • Patients with other malignant tumors;
  • Pregnant, planned pregnancy and lactating female patients (urine HCG>2500IU/L is diagnosed as early pregnancy);
  • Prior chemotherapy, radiation therapy or any other therapies were performed; 12 participated in other tumors within three months of relevant clinical subjects;
  • Those who have participated in other tumor-related clinical trials within three months;
  • Those are not suitable for participating in trials according to investigator's assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Segmentectomy
Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed after a comprehensive evaluation. As with lobectomy, systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy.
Procedure: Segmentectomy
Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Active Comparator: Lobectomy

lobectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively.

The distance from the dissection margin to the tumor edge must be evaluated intraoperatively. If the distance is either less than the maximum tumor diameter or ,20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Procedure: Lobectomy
Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
recurrence-free survival rate
Time Frame: 5 year
Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause
5 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 year
Overall survival (OS) was defined as the time from surgery until death from any cause
5 year
Operation time
Time Frame: 24 hours
The surgery time in both groups.
24 hours
Blood loss
Time Frame: 24 hours
Intraoperative blood loss in total.
24 hours
Post-operative respiratory function
Time Frame: 6 months
The post-operative respiratory function will be evaluated by FEV1% and FVC.
6 months
Perioperative morbidity or mortality
Time Frame: 1 month
Any intraoperative and postoperative complications related to the surgery.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pulmonary Hospital, Shanghai, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chang Chen, MD, PhD, Shanghai Pulmonary Hospital, School of Medicine, Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STAR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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