Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial

Conditions
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Segmentectomy

Intervention / Treatment
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* Device: Energy Instruments
* Device: Stapling Device


Participation Criteria
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Eligibility Criteria
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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: Poor pulmonary reserve or other major comorbidity that contraindicates lobectomy; Peripheral nodule ≤2 cm with at least one of the following: Pure (Adenocarcinoma in situ) AIS histology; Nodule has ≥50% ground-glass appearance on CT; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy Instruments Group<br>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. | Device: Energy Instruments<br>* Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.<br>|
| Experimental: Stapling Device Group<br>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. | Device: Stapling Device<br>* Stapling Device, including linear stapler and curved stapler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Segmentectomy, Postoperative Complication, Stapling Device, Energy Device