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

NCT ID: NCT03192904

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-06-09

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).

Conditions

Segmentectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Energy Instruments

Intervention Type: DEVICE

Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

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.

Group Type: EXPERIMENTAL

Stapling Device

Intervention Type: DEVICE

Stapling Device, including linear stapler and curved stapler.

Interventions

Energy Instruments

Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

Intervention Type: DEVICE

Stapling Device

Stapling Device, including linear stapler and curved stapler.

Intervention Type: DEVICE

Eligibility Criteria

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:

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hecheng Li M.D., Ph.D

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hecheng Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Xingshi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

RTS-004

Identifier Type: -

Identifier Source: org_study_id