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Trial Title:
Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
NCT ID:
NCT05983835
Condition:
IA Lung Adenocarcinoma
Combined Segmentectomy
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Patients receive subsegmentectomy
Description:
Patients receive lobectomy
Arm group label:
combined segmentectomy
Arm group label:
lobectomy
Summary:
This project intends to include stage IA lung adenocarcinoma patients with CT imaging
grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and
compare perioperative complications, differences in lung function and long-term outcomes
between the two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with
GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) ,
Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung
cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of
compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the
largest diameter of compactness was less than 2 cm, the largest diameter of GGO was
less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without
any induction therapy; (6) PS score of 0-1, without severe complications, and
functional status tolerant to minimally invasive lobectomy.
(7) FEV1≥1L was assessed by pulmonary function test and was greater than 50% of the
predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant
metastasis were found in the preoperative clinical evaluation, (9) voluntary
participation and informed consent were obtained;
Exclusion Criteria:
- (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was
located in 1/3 of the lung field, and combined segmental resection may not meet the
requirement of resection margin (3) multiple GGO considered multiple primary lung
cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary
lesion that may require surgical treatment in the next 5 years (4) high risk
patients with severe other organ diseases, (5) history of other malignant tumors
within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was
located in the middle lobe of the right lung, (8) in pregnant or lactating women,
(9) with severe mental disorders, (10) with a history of unstable angina or
myocardial infarction within 6 months, and severe stenosis of the major branches of
the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage
within 6 months, (12) a history of continuous systemic corticosteroid therapy within
1 month, and (13) according to the judgment of the investigators, the patients were
not suitable to be included in the trial.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Start date:
October 1, 2022
Completion date:
October 1, 2025
Lead sponsor:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Wu Jieping Medical Foundation
Agency class:
Other
Source:
Fujian Medical University Union Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983835
