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

N/ATerminatedNCT03192904

Ruijin Hospital70 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Segmentectomy

Interventions

Energy InstrumentsDEVICE

Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

Stapling DeviceDEVICE

Stapling Device, including linear stapler and curved stapler.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

Incidence Rates of Each Postoperative Complications

Time frame: postoperative in-hospital stay up to 30 days

Preoperative Lung Function

Time frame: Baseline.

Postoperative Lung Function at the 3rd Month After Surgery

Time frame: at the 3rd month after surgery

Postoperative Hospital Stay

Time frame: up to 24 weeks

Postoperative ICU Stay

Time frame: up to 24 weeks

Duration of Drainage

Time frame: up to 4 weeks

Mortality in 30 Days After Surgery

Time frame: 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.

Time frame: First day after surgery

Data from ClinicalTrials.gov

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