Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity

A Prospective and Multi-center RCT Study of Lymphadenectomy Based on Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma Presenting With Ground Glass Opacity

The purpose of this study is to evaluate the impact of systematic sampling of lymph nodes vs. lymphadenectomy on outcome according to intraoperative frozen pathology for pulmonary invasive adenocarcinoma with ground-glass opacity (GGO) after VATS lobectomy.

Study Overview

• Status: Recruiting
• Conditions: Lymph Node Excision
• Intervention / Treatment: Procedure: lymphadenectomy; Procedure: systematic sampling of the lymph-node

Detailed Description

On HRCT screening, early lung adenocarcinoma often contains a nonsolid component called ground-glass opacity (GGO). In 2011, pulmonary adenocarcinomas were classified into atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), minimally invasive carcinoma (MIA) and more extensively invasive adenocarcinoma (IAC) [1]. Early adenocarcinomas with GGO-dominant always mean low-grade malignancy and have an extremely favorable prognosis [2-5]. Previous studies have shown that patients with AAH, AIS and MIA have excellent survival rates (5-year survival rate is approximate 95%) after resection, and only 0.83% - 2.91% patients have lymph node metastasis [6-9]. At present, lymphadenectomy is always undergone in patients with pulmonary adenocarcinoma with ground-glass opacity. However, for MIA patients (especially in T1a-b stage), the appropriate use of lymphadenectomy continues to be debated.

Nowadays, intraoperative frozen pathology is widely used during operation. However, whether sampling of lymph nodes or lymphadenectomy should be performed for GGO lesions according to intraoperative pathological diagnosis is unclear. The aim of this prospective study is to evaluate whether there are any trends regarding the impact of subtypes of invasive adenocarcinoma according to intraoperative frozen pathology in sampling of lymph nodes vs. lymphadenectomy.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Chen, M.D. Ph.D.; Phone Number: 13816869003; Email: chenthoracic@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Chang Chen, MD,PhD; Phone Number: 13816869003; Email: chenthoracic@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A peripheral nodular lesion;
2. The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
3. VATS lobectomy
4. 25%≦Consolidation/Tumor ratio ≦50%
5. ECOG performance status 0-2;
6. Without distant metastasis;
7. Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.
8. No operation contraindication
9. Cardiovascular: Cardiac function normal
10. Renal: Creatinine clearance greater than 60 ml/min
11. The expected survival after surgery ≥ 6 months
12. Must be able to sign written informed consent form

Exclusion Criteria:

1. Age less than 18 years old
2. Known hereditary bleeding disorder with history of post-operative hemorrhage
3. Patients maintained on chronic anticoagulation (eg Coumadin therapy)
4. Known hematogenous disorder
5. Known primary or secondary malignancy
6. Pregnant or breast-feeding women;
7. Clinically significant heart disease;
8. Patients who are unwilling or unable to comply with study procedures;
9. Receiving immunosuppressive therapy;
10. HIV/AIDS.
11. Multiple lesions in lung

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lymphadenectomy; systematically Lymphadenectomy of the lymph-node stations ATS 2, 4, 7, 8, 9,10,11 on the right side and ATS 5, 6, 7, 8, 9,10,11 on the left side	Procedure: lymphadenectomy; Routine lymph nodes dissection in lung cancer
Experimental: systematic sampling of the lymph nodes; systematic sampling of the lymph-node stations ATS 2, 4, 7, 8, 9,10,11 on the right side and ATS 5, 6, 7, 8, 9,10,11 on the left side	Procedure: systematic sampling of the lymph-node; Systematic Sampling of lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence-free survival	recurrence-free survival status of patients after surgery	five years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	survival status of patients after surgery	five years after surgery
Morbidity rate	the rates of complications related to treatment during perioperative period	up to 30 days after surgery
Mortality rate	the rates of death related to treatment during perioperative period	up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Collaborators: Changhai Hospital; RenJi Hospital; Shanghai 10th People's Hospital; Ruijin Hospital

Publications and helpful links

General Publications

• 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.
• Ye B, Cheng M, Li W, Ge XX, Geng JF, Feng J, Yang Y, Hu DZ. Predictive factors for lymph node metastasis in clinical stage IA lung adenocarcinoma. Ann Thorac Surg. 2014 Jul;98(1):217-23. doi: 10.1016/j.athoracsur.2014.03.005. Epub 2014 May 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Anticipated): October 28, 2021
• Study Completion (Anticipated): October 28, 2023

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: SHDC12015116

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