Clinical trial Recruiting at 1 site Observational Ages 20 to 79

Comparing two surgical methods for small lung tumors

Official title: Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm With Micropapillary and Solid Subtype Positive by Frozen Section: A Prospective, Observational, Multicenter Cohort Study

Run by Shanghai Pulmonary Hospital, Shanghai, China · NCT05838053 · Data updated 2026-11-12

This study is testing whether two different types of lung surgery work better for people with small lung tumors to see which one helps them live longer without the cancer coming back.

Quick facts

Study typeObservational
Ages20 Years to 79 Years
SexAll
Enrollment446 (estimated)
SponsorShanghai Pulmonary Hospital, Shanghai, China
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Yangpu, Shanghai Municipality)
StatusRecruiting
StartedAugust 20, 2019
Main results expectedApril 30, 2028
Study endsApril 30, 2028
Registry record updatedJuly 27, 2023
Trial IDNCT05838053 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with solitary lung adenocarcinoma tumors ≤ 2 cm that exhibit micropapillary and solid patterns.

Probably not a fit

Patients with tumors located near the hilum or those with suspected lymph node involvement may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness of lobectomy versus segmentectomy in patients with lung adenocarcinoma measuring 2 cm or less, particularly focusing on those with micropapillary and solid subtypes identified through intraoperative frozen sections. The study aims to determine which surgical approach leads to better recurrence-free survival and overall survival rates. By utilizing advanced intraoperative techniques, the research seeks to provide clearer guidance on surgical strategies for small lung tumors. It is a multi-center study conducted at Shanghai Pulmonary Hospital.

Why it matters

Potential benefit: If successful, this study could help determine the most effective surgical approach for patients with small lung adenocarcinoma, potentially improving survival outcomes.

How similar studies have gone: Previous studies have shown promising results in using intraoperative frozen sections to guide surgical decisions, but this specific comparison of lobectomy and segmentectomy remains novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Tumor size ≤ 2 cm;
* Solitary tumor and located in the outer third of the lung field;
* Preoperative CT indicated that the nodules were single nodules or Concomitant nodules was less than minimal invasive adenocarcinoma;
* Intraoperative frozen section confirmed invasive lung adenocarcinoma and with micropapillary and solid patterns positive (\>5%);
* Confirmation of R0 status by intraoperative frozen section analysis;
* Pulmonary function could withstand both segmentectomy and lobectomy (FEV1 \> 1.5 L or FEV1% ≥ 60%);
* Sufficient organ function;
* Performance status of 0,1 or 2;
* Written informed consent.

Exclusion Criteria:

* The tumor is close to the hilum, which cannot perform segmentectomy ;
* Patients suspected of lymph node positive by preoperative examination, including CT scans and mediastinal lymph node biopsy;
* Evidence revealed locally advanced or metastatic disease;
* Intraoperative exploration revealed accidental pleural dissemination.
* Patients with severe damage to heart, liver and kidney function (grade 3 \~ 4, Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) over 3 times the normal upper limit, Cr over the normal upper limit).
* Patients concomitant with other malignant tumors;
* Patients had prior chemotherapy, radiotherapy or molecular targeted therapy for this malignancy.
* History of severe heart disease, heart failure, myocardial infarction within the past 6 months.
* The patients who were not suitable for inclusion by researchers' evaluation.

Where it's running

  • Shanghai Pulmonary Hospital
    Yangpu, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.