Comparing two surgical methods for small lung tumors

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

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 type: Observational
• Enrollment: 446 (estimated)
• Ages: 20 Years to 79 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Yangpu, Shanghai Municipality)
• Trial ID: NCT05838053 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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 performed: 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.

Eligibility 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 this trial is running

Yangpu, Shanghai Municipality

• Shanghai Pulmonary Hospital — Yangpu, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Long Xu, MD

Conditions: Lung Adenocarcinoma, frozen sections, lobectomy, segmentectomy, micropapillary