Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Postoperative Complications

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.

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.

Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

Energy Instruments

Stapling Device, including linear stapler and curved stapler.

Stapling Device

Hecheng Li, MD, PhD

Xingshi Chen, MD

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).

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

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

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).

The duration of chest drainage was different, so we analyzed the drainage volume the first day after surgery of each patient.

Proportion of converting to thoracotomy。

Ruijin Hospital

Professor

The adverse events occurred were described.

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.

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 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.

Stapling Device Group

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

Smoking History

Comorbidity

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%

ASA Grade

Segments resected

Approaches(Video-Assisted Thoracic Surgery or Robotic)

Height

Weight

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.

Prof. Hecheng Li, Chair of Thoracic Surgery

Incidence of Postoperative Complications

Incidence Rates of Each Postoperative Complications

Preoperative Lung Function

Postoperative Lung Function at the 3rd Month After Surgery

Postoperative Hospital Stay

Postoperative ICU Stay

Duration of Drainage

Mortality in 30 Days After Surgery

Drainage Volume of the First Day After Surgery

Data were not collected. Because we found digital drainage system only collect the air leakage rate but not the air leakage volume

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy	NCT03192904	Segmentectomy	Energy Instrume... Stapling Device	18 Years - 70 Years	Ruijin Hospital
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy	NCT03192904	Segmentectomy	Energy Instrume... Stapling Device	18 Years - 70 Years	Ruijin Hospital
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy	NCT03192904	Segmentectomy	Energy Instrume... Stapling Device	18 Years - 70 Years	Ruijin Hospital
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy	NCT03192904	Segmentectomy	Energy Instrume... Stapling Device	18 Years - 70 Years	Ruijin Hospital

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