Lymph Node ExcisionNCT03322826
Systematic Sampling of Lymph Nodes vs. Lymphadenectomy According to Intraoperative Frozen Pathology for Pulmonary Invasive Adenocarcinoma With Ground-glass Opacity
A study testing systematic sampling of the lymph-node and lymphadenectomy in people with Lymph Node Excision, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymph Node Excision
- What is being tested?
- systematic sampling of the lymph-node and lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2017to 28 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A peripheral nodular lesion;
- The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
- VATS lobectomy
- 25%≦Consolidation/Tumor ratio ≦50%
- ECOG performance status 0-2;
- Without distant metastasis;
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- Intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma.
- No operation contraindication
- Cardiovascular: Cardiac function normal
- Renal: Creatinine clearance greater than 60 ml/min
- The expected survival after surgery ≥ 6 months
- Must be able to sign written informed consent form
Who cannot join
- Age less than 18 years old
- Known hereditary bleeding disorder with history of post-operative hemorrhage
- Patients maintained on chronic anticoagulation (eg Coumadin therapy)
- Known hematogenous disorder
- Known primary or secondary malignancy
- Pregnant or breast-feeding women;
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- Clinically significant heart disease;
- Patients who are unwilling or unable to comply with study procedures;
- Receiving immunosuppressive therapy;
- HIV/AIDS.
- Multiple lesions in lung
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Chang Chen, MD,PhD, 13816869003, chenthoracic@163.com
About this study
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
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.
Read the 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.
- Conditions
- Lymph Node Excision
- Being tested
- systematic sampling of the lymph-node, lymphadenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic sampling of the lymph-nodeProcedure or surgery
Systematic Sampling of lymph nodes
lymphadenectomyProcedure or surgery
Routine lymph nodes dissection in lung cancer
| Study group | Role | What they receive |
|---|---|---|
| Lymphadenectomy | Active comparator | 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 Receives: Procedure: lymphadenectomy |
| systematic sampling of the lymph nodes | Experimental | 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 Receives: Procedure: systematic sampling of the lymph-node |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival
recurrence-free survival status of patients after surgery
Measured: five years after surgery
Secondary outcomes (3)
Overall Survival
survival status of patients after surgery
Measured: five years after surgery
Morbidity rate
the rates of complications related to treatment during perioperative period
Measured: up to 30 days after surgery
Mortality rate
the rates of death related to treatment during perioperative period
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start8 Dec 2017
- Primary completion28 Oct 2021 (estimated)
- Study completion28 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymph Node ExcisionStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai 10th People's Hospital, Ruijin Hospital, RenJi Hospital
- Responsible party
- Principal investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322826
- Sponsor's protocol ID
- SHDC12015116
- Status last verified
- Dec 2017
- First submitted
- 23 Oct 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24551879Ye 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.
PubMed 24841547
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03322826
- Acronym / sponsor ID
- SHDC12015116
- Conditions
- Lymph Node Excision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai 10th People's Hospital, Ruijin Hospital, RenJi Hospital
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 28 Oct 2021 (estimated)
- Study completion
- 28 Oct 2023 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphadenectomy | Active comparator | Procedure: lymphadenectomysystematically 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 |
| systematic sampling of the lymph nodes | Experimental | Procedure: systematic sampling of the lymph-nodesystematic 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A peripheral nodular lesion;
- The maximum diameters of whole GGO lesions and solid components on lung windows were no more than 3 cm (T1 stage);
- VATS lobectomy
- 25%≦Consolidation/Tumor ratio ≦50%
- ECOG performance status 0-2;
Key exclusion criteria (11 listed)
- Age less than 18 years old
- Known hereditary bleeding disorder with history of post-operative hemorrhage
- Patients maintained on chronic anticoagulation (eg Coumadin therapy)
- Known hematogenous disorder
- Known primary or secondary malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic sampling of the lymph-nodeSystematic Sampling of lymph nodes | Procedure or surgery | systematic sampling of the lymph nodes |
| lymphadenectomyRoutine lymph nodes dissection in lung cancer | Procedure or surgery | Lymphadenectomy |
Primary outcome
recurrence-free survival
Time frame: five years after surgery
recurrence-free survival status of patients after surgery
3 secondary outcomes
Overall Survival
Time frame: five years after surgery
Morbidity rate
Time frame: up to 30 days after surgery
Mortality rate
Time frame: up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Results publication: PubMed 24551879Tsutani 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.
- Results publication: PubMed 24841547Ye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic sampling of the lymph-node and lymphadenectomy in people with Lymph Node Excision, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Chen, M.D. Ph.D. (13816869003, chenthoracic@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival (time frame: five years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.