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NCT Number: NCT05838053

Comparison of Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm

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

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Deping Zhao, MD, PhD

CONTACT

[email protected]

+86-021-65115006

About this study

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 whether segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the superiority in recurrence free survival and overall survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma (≤ 2 cm) containing positive micropapillary components.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lobectomy with systemic lymph node dissection

Procedure

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.

Segmentectomy with systemic lymph node dissection

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. overall survival rate

    Time frame: 5 year

    Overall survival (OS) was defined as the time from surgery until death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Long Xu, MD

CONTACT

[email protected]

15801783037

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
May 1, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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