Clinical trial NCT03192904: Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy
Official title: Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Segmentectomy
Keywords: Lung cancer
Segmentectomy
Postoperative Complication
Stapling Device
Energy Device
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Incidence of Postoperative Complications
timeFrame: postoperative in-hospital stay up to 30 days
Secondary outcomes:
measure: Incidence Rates of Each Postoperative Complications
timeFrame: postoperative in-hospital stay up to 30 days
measure: Preoperative Lung Function
timeFrame: Baseline.
measure: Postoperative Lung Function at the 3rd Month After Surgery
timeFrame: at the 3rd month after surgery
measure: Postoperative Hospital Stay
timeFrame: up to 24 weeks
measure: Postoperative ICU Stay
timeFrame: up to 24 weeks
measure: Duration of Drainage
timeFrame: up to 4 weeks
measure: Mortality in 30 Days After Surgery
timeFrame: postoperative in-hospital stay up to 30 days
measure: Drainage Volume of the First Day After Surgery
timeFrame: First day after surgery
measure: Daily Air Leakage Volume
timeFrame: During drainage time, up to 4 weeks
measure: Duration of Surgery
timeFrame: During surgery
measure: Blood Loss During Surgery
timeFrame: During surgery
measure: Number of Conversions
timeFrame: During surgery
measure: Participants With Malignant Tumors
timeFrame: 2 weeks after surgery
measure: Medical Costs
timeFrame: During hospital stay, up to 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Hecheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Xingshi Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: