Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
Phase: NA
Conditions: Segmentectomy
Sponsor: Ruijin Hospital

A Comparison of Energy Instruments and 
Stapling Devices to Dissect Intersegmental 
Planes in Segmentectomy: A Randomized 
Controlled Trial 
 
Department of Thoracic Surgery 
Ruijin Hospital Shanghai JiaoTong University School of Medicine 
 
 
Registration Number: NCT03192904 (www.clinicaltrials.gov) 
Date: May 13, 2017 
 
 
 

 
Objectives 
Because of the common use of low-dose computed tomography (CT) and other means of 
examination, there is an increasing number of patients diagnosed with small pulmonary nodules. 
Anatomical segementectomy has been one of the standard surgical treatments for these patients. 
The two main approaches in dissection of the intersegmental plane involve a stapling device and 
energy instrument separation. Our study will compare the perioperative outcomes of these two 
approaches. The primary outcome will be the percentages of postoperative complications. The 
secondary outcomes will be preoperative and postoperative lung function, duration of surgery, 
blood loss during surgery, postoperative hospital stay, and the duration of drainage. 
 
Background 
Lung cancer is one of the most serious life-threatening diseases. It has the highest worldwide 
morbidity and mortality among all malignant tumors [1]. Because of the frequent use of low-dose 
CT and other means of examination [2], an increasing number of patients with lung cancer are 
detected in the early phase of the disease. Anatomical segementectomy is one of the standard 
surgical procedures [3] for small pulmonary nodules or ground glass opacities (GGOs), which are 
highly suspect or pathologically confirmed as early lung cancer lesions.  
Dissection of the intersegmental plane during segementectomy is challenging for thoracic 
surgeons because of complicated anatomical relationships and variations and the lack of a 
boundary between pulmonary segments. There are two main approaches in the dissection of the 
intersegmental plane [4][5] that involve stapling devices and an energy instrument separation. 
However, only a few retrospective studies have reported the perioperative outcomes of these two 
approaches in traditional segmentectomy and robot-assisted segmentectomy.  
Yoshikazu Miyasaka and his colleagues [6] conducted a retrospective study of 49 patients who 
underwent segmentectomy of the lung in 2010. The intersegmental plane was divided with only a 
mechanical stapler in 18 patients, and electrocautery was used in the other 31 patients. There was 
no significant relationship between the methods of making intersegmental planes and 
postoperative complications and/or lung functions. Takashi Ohtsuka et al. [7] analyzed 47 patients 
who underwent segmentectomy in 2012. Twenty-two patients underwent intersegmental plane 
dissection with electrocautery alone, and 25 patients underwent intersegmental plane dissection in 
combination with electrocautery and staplers. There was no statistical difference between the 
electrocautery alone group compared with the group treated with a combination of electrocautery 
and staplers in the duration of surgery (282 vs. 290 minutes), intraoperative blood loss (203 vs. 
151 mL), duration of chest tube placement (3.2 vs. 3.1 days), postoperative hospital stay (11.0 vs. 
10.0 days), postoperative loss of forced expiratory volume during the first second (13 vs. 8%), loss 
of forced vital capacity (11 vs. 6%), or incidence of minor postoperative complications [9% (2/22) 
vs. 16% (4/25); p = 0.30]. However, the incidence of prolonged air leaks was higher in the 
electrocautery alone group than in the group treated with a combination of electrocautery and 
staplers [14% (3/22) vs. 4% (1/25); p = 0.025]. The cost of materials for sealing the air leaks was 
€964 per patient in the electrocautery alone group and €1,594 per patient in the group treated with 
a combination of electrocautery and staplers. Hiroyuki Tao [8] also performed a retrospective 
study on lung function in 2016. The intersegmental planes were divided by either electrocautery or 

with a stapler in 22 patients and with a stapler alone in 19 patients. There was no correlation 
between the actual/predicted ratio of remnant lung volume and pulmonary function based on the 
method of division. 
As previously mentioned, there has been no definitive conclusion about which method is better. 
We expect the use of a stapling device will result in less perioperative complications but will have 
disadvantages in the reservation of lung functions and medical costs. To compare the feasibility, 
safety, and economic efficiency between these two methods, we plan to conduct a prospective 
study. 
 
References 
1. Stewart BW, Wild CP. World Cancer Report 2014. Lyon: International Agency for Research 
On Cancer; 2014. 
2. Corbin D. Jacobs, Mary Ellen Jafari. Early Results of Lung Cancer Screening and Radiation 
Dose Assessment by Low-dose CT at a Community Hospital. Clin Lung Cancer. 2017 Feb 2. 
pii: S1525-7304(17)30040-2. 
3. Chenyang Dai, Jianfei Shen, Yijiu Ren, Shengyi Zhong, Hui Zheng, Jiaxi He, Dong Xie, Ke 
Fei, Wenhua Liang, Gening Jiang, Ping Yang, Rene Horsleben Petersen, Calvin S.H. Ng, 
Chia-Chuan Liu, Gaetano Rocco, Alessandro Brunelli, Yaxing Shen, Chang Chen, Jianxing 
He. Choice of Surgical Procedure for Patients With Non-Small-Cell Lung Cancer ≤ 1 cm or > 
1 to 2 cm Among Lobectomy, Segmentectomy, and Wedge Resection: A Population-Based 
Study. J Clin Oncol. 2016 Sep 10;34(26):3175-82. 
4. Amaia Ojanguren, Dominique Gossot, Agathe Seguin-Givelet. Division of the intersegmental 
plane during thoracoscopic segmentectomy: is stapling an issue? J Thorac Dis. 2016 
Aug;8(8):2158-64. 
5. Xiaojing Zhao, Liqiang Qian, Qingquan Luo, Jia Huang. Segmentectomy as a safe and 
equally effective surgical option under complete video-assisted thoracic surgery for patients of 
stage I non-small cell lung cancer. J Cardiothorac Surg. 2013 Apr 29;8:116. 
6. Yoshikazu Miyasaka, Shiaki Oh, Nobumasa Takahashi, Kazuya Takamochi, Kenji Suzuki. 
Postoperative complications and respiratory function following segmentectomy of the lung - 
comparison of the methods of making an inter-segmental plane. Interact Cardiovasc Thorac 
Surg. 2011 Mar;12(3):426-9. 
7. Takashi Ohtsuka, Taichiro Goto, Masaki Anraku, Mitsutomo Kohno, Yotaro Izumi, Hirohisa 
Horinouchi, Hiroaki Nomori. Dissection of lung parenchyma using electrocautery is a safe 
and acceptable method for anatomical sublobar resection. J Cardiothorac Surg. 2012 May 
3;7:42. 
8. Hiroyuki Tao, Toshiki Tanaka, Tatsuro Hayashi, Kumiko Yoshida, Masashi Furukawa, Koichi 
Yoshiyama, Kazunori Okabe. Influence of stapling the intersegmental planes on lung volume 
and function after segmentectomy. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):548-52. 
 
Research Strategy  
We propose to conduct a prospective, single-center, single-blind, randomized, controlled trial. 
 
Inclusion Criteria:  
1. Age: 18–70 years of age 

2. Pulmonary nodules or GGO found in chest CT examinations that conform with indications for 
segmentectomy mentioned in the National Comprehensive Cancer Network 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 histology; 
     2) Nodule has ≥50% ground-glass appearance on CT; 
     3) Radiologic surveillance confirms a long doubling time (≥400 days). 
3. Normal preoperative tests, such as routine blood examinations, liver function, renal function, 
and coagulation function. 
4. American Society of Anesthesiologists score: Grades I–III 
5. Patients coordinated with treatment and research and who provide informed consent 
 
Exclusion Criteria: 
1. Patients with a history of a malignant tumor or who have accepted neoadjuvant chemotherapy 
and/or radiotherapy 
2. Patients with comorbidities in the cardiovascular, kidney, lung, or hematopoietic system who 
cannot tolerate the surgery 
3. Psychiatric patients 
4. Patient who have a history of chest trauma or surgery in the ipsilateral chest. 
 
Case Load: 
We will set the incidence percentage of postoperative complications as our primary endpoint. 
According to our calculations, a total of 136 patients will be enrolled (each group will be 
comprised of 68 patients). Based on our previous clinical observations and current reports, a 
sample size of 62 participants per group is estimated to provide a 90% power to detect a 
between-group difference of 10% incidence percentage of postoperative complications in the 
stapling device group and 33% in the energy instrument group, with a two-sided significance level 
of 5%. To compensate for a 10% loss to follow-up in the prespecified subgroup analyses, the 
sample size will be increased to 68 participants in each group. 
  
Surgical Procedures: 
All enrolled patients will be treated with robot-assisted segmentectomy. After removing the 
relevant segmental arteries, veins, and bronchus, the lung will be fully inflated. The border of the 
segment will appear after recollapse of the lung, because the targeted segment should remain 
inflated. We will use the da Vinci monopolar cautery hook or da Vinci Harmonic™ ACE, or Endo 
GIA™ or Echelon™ auto-suture single use stapler and single use reload device to dissect the 
intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, 
we will perform a lymphadenectomy. Finally, a drainage tube will be inserted. 
 
Primary Endpoints: 
The incidence percentage of postoperative complications, including air leakage, atelectasis, 
hemorrhage, pulmonary infection, and pulmonary embolism 
 
Secondary Endpoints: 

1. The incidence percentage of each postoperative complication (especially air leakage, which will 
be quantified by the Medela Thopaz™ digital quantitative chest drainage system) 
2. Preoperative lung function, postoperative lung function on the 3rd day and 1st month after 
surgery 
3. Postoperative hospital stay, postoperative intensive care unit stay, duration of drainage, and 
mortality at 30 days after surgery 
4. The duration of surgery, blood loss during surgery, and the percentage of conversion to open 
surgery 
5. Tumor location, pathological results, number of dissected lymph nodes, and the TMN stage 
6. Medical costs (including total medical costs and the cost of materials) 
 
 
Statistical Analysis:  
An independent data monitoring committee (DMC) reviewed data from the study after 35 and 70 
participants were recruited. The results of these interim checks were known only to the data 
manager and DMC. The trial was stopped early by the DMC due to a marked difference between 
groups after recruiting 70 patients.  
Analysis was performed on an intention-to-treat basis. All analyses were performed using SPSS 
software (version 23; IBM SPSS, Chicago, IL, USA). Primary outcome analysis was performed 
by a simple categorical frequency comparison using a χ-square test. Secondary outcome analyses 
included unpaired Student’s t tests for duration of surgery, duration of drainage, postoperative 
hospital stay, lung function, and medical costs; Mann-Whitney U tests for blood loss during 
surgery and postoperative ICU stay; and χ-square tests for the percentage of conversion to open 
surgery and mortality at 30 days after surgery. Sensitivity analysis of the primary outcome using 
logistic regression was undertaken to adjust for gender, age, smoking, tumor location, approach 
(robotic or VATS), and method of dissecting intersegmental planes (stapling device or energy 
instrument).