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

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ClinicalTrials.gov Identifier: NCT03322826
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Changhai Hospital
Shanghai 10th People's Hospital
Ruijin Hospital
RenJi Hospital
Information provided by (Responsible Party):
Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymph Node Excision Procedure: systematic sampling of the lymph-node Procedure: lymphadenectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective and Multi-center RCT Study of Lymphadenectomy Based on Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma Presenting With Ground Glass Opacity
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




Primary Outcome Measures :
  1. recurrence-free survival [ Time Frame: five years after surgery ]
    recurrence-free survival status of patients after surgery


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: five years after surgery ]
    survival status of patients after surgery

  2. Morbidity rate [ Time Frame: up to 30 days after surgery ]
    the rates of complications related to treatment during perioperative period

  3. Mortality rate [ Time Frame: up to 30 days after surgery ]
    the rates of death related to treatment during perioperative period



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322826


Contacts
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Contact: Chang Chen, M.D. Ph.D. 13816869003 chenthoracic@163.com

Locations
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China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Chang Chen, MD,PhD    13816869003    chenthoracic@163.com   
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Changhai Hospital
Shanghai 10th People's Hospital
Ruijin Hospital
RenJi Hospital

Publications of Results:
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Responsible Party: Chang Chen, Vice President, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03322826     History of Changes
Other Study ID Numbers: SHDC12015116
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms