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

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.

Study Overview

• Status: Terminated
• Conditions: Segmentectomy
• Intervention / Treatment: Device: Energy Instruments; Device: Stapling Device

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).

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Energy Instruments; Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
Experimental: 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.	Device: Stapling Device; Stapling Device, including linear stapler and curved stapler.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Hecheng Li, MD, PhD, Ruijin Hospital; Principal Investigator: Xingshi Chen, MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): March 9, 2018
• Study Completion (Actual): June 9, 2018

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Lung cancer; Postoperative Complication; Segmentectomy; Stapling Device; Energy Device
• Other Study ID Numbers: RTS-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No