Segmentectomy
Conditions
Keywords
Lung cancer, Segmentectomy, Postoperative Complication, Stapling Device, Energy Device
Brief summary
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.
Detailed description
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).
Interventions
DEVICEEnergy Instruments
Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
DEVICEStapling Device
Stapling Device, including linear stapler and curved stapler.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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: 1. Poor pulmonary reserve or other major comorbidity that contraindicates lobectomy; 2. Peripheral nodule ≤2 cm with at least one of the following: <!-- --> 1. Pure (Adenocarcinoma in situ) AIS histology; 2. Nodule has ≥50% ground-glass appearance on CT; 3. Radiologic surveillance confirms a long doubling time (≥400 days). 3. Normal in preoperative tests, such as blood routine examination, liver function, renal function, coagulation function, etc. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Complications | postoperative in-hospital stay up to 30 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Lung Function | Baseline. | — |
| Postoperative Lung Function at the 3rd Month After Surgery | 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 | — |
| Incidence Rates of Each Postoperative Complications | postoperative in-hospital stay up to 30 days | — |
| 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 | During surgery | Proportion of converting to thoracotomy。 |
| Participants With Malignant Tumors | 2 weeks after surgery | — |
| Medical Costs | During hospital stay, up to 24 weeks | — |
| Drainage Volume of the First Day After Surgery | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 3 | 1 |
Baseline characteristics
| Characteristic | Energy Instruments Group | Stapling Device Group | Total |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 10.4 | 53.3 years STANDARD_DEVIATION 10.7 | 52.7 years STANDARD_DEVIATION 10.4 |
| Approaches(Video-Assisted Thoracic Surgery or Robotic) Robotic | 27 Participants | 23 Participants | 50 Participants |
| Approaches(Video-Assisted Thoracic Surgery or Robotic) Video-Assisted Thoracic Surgery | 5 Participants | 10 Participants | 15 Participants |
| ASA Grade I | 0 Participants | 3 Participants | 3 Participants |
| ASA Grade II | 31 Participants | 29 Participants | 60 Participants |
| ASA Grade III | 1 Participants | 1 Participants | 2 Participants |
| Comorbidity | 10 Participants | 11 Participants | 21 Participants |
| Height | 162.9 cm STANDARD_DEVIATION 6.7 | 164.5 cm STANDARD_DEVIATION 7.7 | 163.7 cm STANDARD_DEVIATION 7.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 32 Participants | 33 Participants | 65 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 32 participants | 33 participants | 65 participants |
| Segments resected LS10 | 0 Participants | 1 Participants | 1 Participants |
| Segments resected LS1+2 | 7 Participants | 1 Participants | 8 Participants |
| Segments resected LS1+2+LS3 | 2 Participants | 4 Participants | 6 Participants |
| Segments resected LS1+2+LS3c | 0 Participants | 1 Participants | 1 Participants |
| Segments resected LS3 | 1 Participants | 1 Participants | 2 Participants |
| Segments resected LS3c | 1 Participants | 0 Participants | 1 Participants |
| Segments resected LS4+LS5 | 1 Participants | 3 Participants | 4 Participants |
| Segments resected LS6 | 3 Participants | 1 Participants | 4 Participants |
| Segments resected LS6+LS8 | 0 Participants | 1 Participants | 1 Participants |
| Segments resected LS7+LS8+LS9+LS10 | 0 Participants | 1 Participants | 1 Participants |
| Segments resected LS9 | 1 Participants | 0 Participants | 1 Participants |
| Segments resected RS1 | 9 Participants | 5 Participants | 14 Participants |
| Segments resected RS1a+RS2 | 0 Participants | 2 Participants | 2 Participants |
| Segments resected RS1b+RS3 | 0 Participants | 1 Participants | 1 Participants |
| Segments resected RS1b+RS3b | 0 Participants | 1 Participants | 1 Participants |
| Segments resected RS1+RS2 | 0 Participants | 1 Participants | 1 Participants |
| Segments resected RS2 | 0 Participants | 3 Participants | 3 Participants |
| Segments resected RS2b+RS3a | 0 Participants | 1 Participants | 1 Participants |
| Segments resected RS3 | 2 Participants | 1 Participants | 3 Participants |
| Segments resected RS6 | 2 Participants | 4 Participants | 6 Participants |
| Segments resected RS8 | 1 Participants | 0 Participants | 1 Participants |
| Segments resected RS8b+RS9 | 1 Participants | 0 Participants | 1 Participants |
| Segments resected RS9+RS10 | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
| Smoking History | 6 Participants | 3 Participants | 9 Participants |
| Weight | 60.0 kg STANDARD_DEVIATION 8.1 | 63.4 kg STANDARD_DEVIATION 8.7 | 61.7 kg STANDARD_DEVIATION 8.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 1 / 32 | 1 / 33 |
Outcome results
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).
Time frame: postoperative in-hospital stay up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Energy Instruments Group | Incidence of Postoperative Complications | 11 Participants |
| Stapling Device Group | Incidence of Postoperative Complications | 2 Participants |
p-value: 0.004Chi-squared
Secondary
Blood Loss During Surgery
Time frame: During surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Energy Instruments Group | Blood Loss During Surgery | 100 ml |
| Stapling Device Group | Blood Loss During Surgery | 100 ml |
Secondary
Daily Air Leakage Volume
Time frame: During drainage time, up to 4 weeks
Population: Data were not collected. Because we found digital drainage system only collect the air leakage rate but not the air leakage volume
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.
Time frame: First day after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Energy Instruments Group | Drainage Volume of the First Day After Surgery | 176 Milliliter | Standard Deviation 122.53 |
| Stapling Device Group | Drainage Volume of the First Day After Surgery | 142 Milliliter | Standard Deviation 94.98 |
Secondary
Duration of Drainage
Time frame: up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Energy Instruments Group | Duration of Drainage | 3.91 days | Standard Deviation 2.47 |
| Stapling Device Group | Duration of Drainage | 3.27 days | Standard Deviation 1.53 |
Secondary
Duration of Surgery
Time frame: During surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Energy Instruments Group | Duration of Surgery | 138.4 min | Standard Deviation 35.9 |
| Stapling Device Group | Duration of Surgery | 143.0 min | Standard Deviation 35.7 |
Secondary
Incidence Rates of Each Postoperative Complications
Time frame: postoperative in-hospital stay up to 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Energy Instruments Group | Incidence Rates of Each Postoperative Complications | Pneumothorax | 3 Participants |
| Energy Instruments Group | Incidence Rates of Each Postoperative Complications | Cardiac arrest | 1 Participants |
| Energy Instruments Group | Incidence Rates of Each Postoperative Complications | Septic shock | 0 Participants |
| Energy Instruments Group | Incidence Rates of Each Postoperative Complications | No complications | 21 Participants |
| Energy Instruments Group | Incidence Rates of Each Postoperative Complications | Air leakage | 7 Participants |
| Stapling Device Group | Incidence Rates of Each Postoperative Complications | No complications | 31 Participants |
| Stapling Device Group | Incidence Rates of Each Postoperative Complications | Air leakage | 1 Participants |
| Stapling Device Group | Incidence Rates of Each Postoperative Complications | Pneumothorax | 0 Participants |
| Stapling Device Group | Incidence Rates of Each Postoperative Complications | Septic shock | 1 Participants |
| Stapling Device Group | Incidence Rates of Each Postoperative Complications | Cardiac arrest | 0 Participants |
Secondary
Medical Costs
Time frame: During hospital stay, up to 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Energy Instruments Group | Medical Costs | Cost of medical materials | 4214.6 USD | Standard Deviation 1185.4 |
| Energy Instruments Group | Medical Costs | Total medical cost | 11136.2 USD | Standard Deviation 1902 |
| Stapling Device Group | Medical Costs | Cost of medical materials | 3260.1 USD | Standard Deviation 352.6 |
| Stapling Device Group | Medical Costs | Total medical cost | 111602.5 USD | Standard Deviation 2788.9 |
Secondary
Mortality in 30 Days After Surgery
Time frame: postoperative in-hospital stay up to 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Energy Instruments Group | Mortality in 30 Days After Surgery | 0 case |
| Stapling Device Group | Mortality in 30 Days After Surgery | 0 case |
Secondary
Number of Conversions
Proportion of converting to thoracotomy。
Time frame: During surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Energy Instruments Group | Number of Conversions | 0 case |
| Stapling Device Group | Number of Conversions | 0 case |
Secondary
Participants With Malignant Tumors
Time frame: 2 weeks after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Energy Instruments Group | Participants With Malignant Tumors | 27 Participants |
| Stapling Device Group | Participants With Malignant Tumors | 30 Participants |
Secondary
Postoperative Hospital Stay
Time frame: up to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Energy Instruments Group | Postoperative Hospital Stay | 4.75 days | Standard Deviation 2.38 |
| Stapling Device Group | Postoperative Hospital Stay | 4.24 days | Standard Deviation 2 |
Secondary
Postoperative ICU Stay
Time frame: up to 24 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Energy Instruments Group | Postoperative ICU Stay | With ICU stays | 0 Participants |
| Energy Instruments Group | Postoperative ICU Stay | Without ICU stays | 32 Participants |
| Stapling Device Group | Postoperative ICU Stay | With ICU stays | 1 Participants |
| Stapling Device Group | Postoperative ICU Stay | Without ICU stays | 32 Participants |
Secondary
Postoperative Lung Function at the 3rd Month After Surgery
Time frame: at the 3rd month after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Energy Instruments Group | Postoperative Lung Function at the 3rd Month After Surgery | 2.25 L | Standard Deviation 0.52 |
| Stapling Device Group | Postoperative Lung Function at the 3rd Month After Surgery | 2.37 L | Standard Deviation 0.62 |
Secondary
Preoperative Lung Function
Time frame: Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Energy Instruments Group | Preoperative Lung Function | 2.73 L | Standard Deviation 0.5 |
| Stapling Device Group | Preoperative Lung Function | 2.80 L | Standard Deviation 0.74 |