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One treatment policy showed an advantage at a very high significance level.
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According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.
Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Due to the popularization of low-dose CT and other means of examination, more and more patients with lung cancer are detected in the early phase of disease. Anatomical segmentectomy is one of the standard surgical procedures for these small pulmonary nodules or ground glass opacity (GGO), which are clinically highly suspected or puncture confirmed early lung cancer lesions. Dissection of the intersegmental plane in segmentectomy is a difficulty that have puzzled thoracic surgeons for decades because of the complicated anatomic relationship and variations, along with lack of boundary between pulmonary segments. There are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches in segmentectomy, not to mention in robot assisted segmentectomy, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.
The investigators set incidence rate of postoperative complications as their primary endpoint. According to their calculation, a total of 136 patients will be enrolled (each group has 68 patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Instruments Group | Experimental | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. |
|
| Stapling Device Group | Experimental | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Instruments | Device | Energy Instruments, including electrocautery, harmonic scalpel and LigaSure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Complications | The primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow >50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan). | postoperative in-hospital stay up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rates of Each Postoperative Complications | postoperative in-hospital stay up to 30 days | |
| Preoperative Lung Function | Baseline. | |
| Postoperative Lung Function at the 3rd Month After Surgery |
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Inclusion Criteria:
1. Age: 18 to 70 years old; 2. Pulmonary nodules or GGO found in chest CT examination, and conform with indications for segmentectomy mentioned in NCCN guidelines:
4. ASA score: Grade I-III. 5. Patients who can coordinate the treatment and research and sign the informed consent.
Exclusion Criteria:
1. Patients have history of malignant tumor, or have accepted neoadjuvant chemotherapy and(or) radiotherapy.
2. Patients have comorbidities in cardiovascular, kidney, lung or hematopoietic system, who cannot tolerate the surgery.
3. Psychiatric patients。 4. Patient have history of chest trauma or surgery on ipsilateral chest.
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| Name | Affiliation | Role |
|---|---|---|
| Hecheng Li, MD, PhD | Ruijin Hospital | Principal Investigator |
| Xingshi Chen, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Energy Instruments Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure. |
| FG001 | Stapling Device Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Stapling Device: Stapling Device, including linear stapler and curved stapler. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Energy Instruments Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Postoperative Complications | The primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow >50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan). | Posted | Count of Participants | Participants | postoperative in-hospital stay up to 30 days |
|
Three months after surgery.
The adverse events occurred were described.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Energy Instruments Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | Infections and infestations | Non-systematic Assessment |
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First, we only used electrocautery to divide intersegmental planes in the energy instrument group. Second, the single-center design might lead to selection bias. Third, oncological outcomes were not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Hecheng Li, Chair of Thoracic Surgery | Ruijin Hospital Shanghai JiaoTong University School of Medicine | (86)13917113402 | lihecheng2000@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2017 | Oct 11, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2017 | Oct 11, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Stapling Device | Device | Stapling Device, including linear stapler and curved stapler. |
|
| at the 3rd month after surgery |
| Postoperative Hospital Stay | up to 24 weeks |
| Postoperative ICU Stay | up to 24 weeks |
| Duration of Drainage | up to 4 weeks |
| Mortality in 30 Days After Surgery | postoperative in-hospital stay up to 30 days |
| Drainage Volume of the First Day After Surgery | The duration of chest drainage was different, so we analyzed the drainage volume the first day after surgery of each patient. | First day after surgery |
| Daily Air Leakage Volume | During drainage time, up to 4 weeks |
| Duration of Surgery | During surgery |
| Blood Loss During Surgery | During surgery |
| Number of Conversions | Proportion of converting to thoracotomy。 | During surgery |
| Participants With Malignant Tumors | 2 weeks after surgery |
| Medical Costs | During hospital stay, up to 24 weeks |
| BG001 | Stapling Device Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Stapling Device: Stapling Device, including linear stapler and curved stapler. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking History | Count of Participants | Participants |
|
| Comorbidity | Count of Participants | Participants |
|
| ASA Grade | American Society of Anesthesiologists (ASA) grade is the most commonly used grading system that predicts morbidity and mortality. I: Healthy individual with no systemic disease, MORTALITY 0.05% II: Mild systemic disease not limiting activity, MORTALITY 0.4% III: Severe systemic disease that limits activity but is not incapacitating , MORTALITY 4.5% IV: Incapacitating systemic disease which is constantly life-threatening , MORTALITY 25% V: Moribund, not expected to survive 24 hours with or without surgery , MORTALITY 50% | Count of Participants | Participants |
|
| Segments resected | Count of Participants | Participants |
|
| Approaches(Video-Assisted Thoracic Surgery or Robotic) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | Stapling Device Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Stapling Device: Stapling Device, including linear stapler and curved stapler. |
|
|
|
| Secondary | Incidence Rates of Each Postoperative Complications | Posted | Count of Participants | Participants | postoperative in-hospital stay up to 30 days |
|
|
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| Secondary | Preoperative Lung Function | Posted | Mean | Standard Deviation | L | Baseline. |
|
|
|
| Secondary | Postoperative Lung Function at the 3rd Month After Surgery | Posted | Mean | Standard Deviation | L | at the 3rd month after surgery |
|
|
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| Secondary | Postoperative Hospital Stay | Posted | Mean | Standard Deviation | days | up to 24 weeks |
|
|
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| Secondary | Postoperative ICU Stay | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Secondary | Duration of Drainage | Posted | Mean | Standard Deviation | days | up to 4 weeks |
|
|
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| Secondary | Mortality in 30 Days After Surgery | Posted | Number | case | postoperative in-hospital stay up to 30 days |
|
|
|
| Secondary | Drainage Volume of the First Day After Surgery | The duration of chest drainage was different, so we analyzed the drainage volume the first day after surgery of each patient. | Posted | Mean | Standard Deviation | Milliliter | First day after surgery |
|
|
|
| Secondary | Daily Air Leakage Volume | Data were not collected. Because we found digital drainage system only collect the air leakage rate but not the air leakage volume | Posted | During drainage time, up to 4 weeks |
|
|
| Secondary | Duration of Surgery | Posted | Mean | Standard Deviation | min | During surgery |
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| Secondary | Blood Loss During Surgery | Posted | Median | Inter-Quartile Range | ml | During surgery |
|
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| Secondary | Number of Conversions | Proportion of converting to thoracotomy。 | Posted | Number | case | During surgery |
|
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| Secondary | Participants With Malignant Tumors | Posted | Count of Participants | Participants | 2 weeks after surgery |
|
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| Secondary | Medical Costs | Posted | Mean | Standard Deviation | USD | During hospital stay, up to 24 weeks |
|
|
|
| 0 |
| 32 |
| 1 |
| 32 |
| 0 |
| 32 |
| EG001 | Stapling Device Group | All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Stapling Device: Stapling Device, including linear stapler and curved stapler. | 0 | 33 | 1 | 33 | 0 | 33 |
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Septic shock |
|
| Cardiac arrest |
|
| No complications |
|