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

Segmentectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03192904
• Other study ID #: RTS-004
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 9, 2018

Study information

• Verified date: August 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: June 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Segmentectomy

Intervention

Device:
• Energy Instruments
Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
• Stapling Device
Stapling Device, including linear stapler and curved stapler.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence Rates of Each Postoperative Complications		postoperative in-hospital stay up to 30 days
Secondary	Preoperative Lung Function		Baseline.
Secondary	Postoperative Lung Function at the 3rd Month After Surgery		at the 3rd month after surgery
Secondary	Postoperative Hospital Stay		up to 24 weeks
Secondary	Postoperative ICU Stay		up to 24 weeks
Secondary	Duration of Drainage		up to 4 weeks
Secondary	Mortality in 30 Days After Surgery		postoperative in-hospital stay up to 30 days
Secondary	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
Secondary	Daily Air Leakage Volume		During drainage time, up to 4 weeks
Secondary	Duration of Surgery		During surgery
Secondary	Blood Loss During Surgery		During surgery
Secondary	Number of Conversions	Proportion of converting to thoracotomy?	During surgery
Secondary	Participants With Malignant Tumors		2 weeks after surgery
Secondary	Medical Costs		During hospital stay, up to 24 weeks