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

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ClinicalTrials.gov Identifier: NCT03192904
Recruitment Status : Terminated (The trial was stopped early by data monitoring committee (DMC) because one treatment policy showed an advantage at a very high significance level.)
First Posted : June 20, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hecheng Li M.D., Ph.D, Ruijin Hospital

Tracking Information
First Submitted Date  ICMJE June 12, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date July 31, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date March 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
Incidence rate of postoperative complications [ Time Frame: postoperative in-hospital stay up to 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03192904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • Incidence rates of each postoperative complications [ Time Frame: postoperative in-hospital stay up to 30 days ]
    including air leakage, atelectasis, hemorrhage, pulmonary infections, pulmonary embolism, etc.
  • Preoperative lung function [ Time Frame: Baseline. ]
  • Postoperative lung function at the 3rd month after surgery [ Time Frame: at the 3rd month after surgery ]
  • Postoperative hospital stay [ Time Frame: up to 24 weeks ]
  • Postoperative ICU stay [ Time Frame: up to 24 weeks ]
  • Duration of drainage [ Time Frame: up to 4 weeks ]
  • Mortality in 30 days after surgery [ Time Frame: postoperative in-hospital stay up to 30 days ]
  • Daily drainage volume [ Time Frame: During drainage time, up to 4 weeks ]
  • Daily air leakage volume [ Time Frame: During drainage time, up to 4 weeks ]
  • Duration of surgery [ Time Frame: During surgery ]
  • Blood loss during surgery [ Time Frame: During surgery ]
  • Conversive rate [ Time Frame: During surgery ]
  • Pathological patterns [ Time Frame: 2 weeks after surgery ]
    Tumor location, pathological results, number of dissected lymph nodes, TMN stage.
  • Medical costs [ Time Frame: During hospital stay, up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
  • Incidence rates of each postoperative complications [ Time Frame: postoperative in-hospital stay up to 30 days ]
    including air leakage, atelectasis, hemorrhage, pulmonary infections, pulmonary embolism, etc.
  • Preoperative lung function [ Time Frame: Baseline. ]
  • Postoperative lung function at the 3rd day after surgery [ Time Frame: at the 3rd day after surgery ]
  • Postoperative lung function at the 30th day after surgery [ Time Frame: at the 30th day after surgery ]
  • Postoperative hospital stay [ Time Frame: up to 24 weeks ]
  • Postoperative ICU stay [ Time Frame: up to 24 weeks ]
  • Duration of drainage [ Time Frame: up to 4 weeks ]
  • Mortality in 30 days after surgery [ Time Frame: postoperative in-hospital stay up to 30 days ]
  • Daily drainage volume [ Time Frame: During drainage time, up to 4 weeks ]
  • Daily air leakage volume [ Time Frame: During drainage time, up to 4 weeks ]
  • Duration of surgery [ Time Frame: During surgery ]
  • Blood loss during surgery [ Time Frame: During surgery ]
  • Conversive rate [ Time Frame: During surgery ]
  • Pathological patterns [ Time Frame: 2 weeks after surgery ]
    Tumor location, pathological results, number of dissected lymph nodes, TMN stage.
  • Medical costs [ Time Frame: During hospital stay, up to 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy
Official Title  ICMJE Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
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 segementectomy 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 segementectomy 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Segmentectomy
Intervention  ICMJE
  • Device: Energy Instruments
    Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
  • Device: Stapling Device
    Stapling Device, including linear stapler and curved stapler.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Energy Instruments
  • 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.
    Intervention: Device: Stapling Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 27, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2017)
136
Actual Study Completion Date  ICMJE June 9, 2018
Actual Primary Completion Date March 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192904
Other Study ID Numbers  ICMJE RuijinH-2017059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hecheng Li M.D., Ph.D, Ruijin Hospital
Study Sponsor  ICMJE Ruijin Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hecheng Li, MD, PhD Ruijin Hospital
Principal Investigator: Xingshi Chen, MD Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP