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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

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.

Condition or disease Intervention/treatment Phase
Segmentectomy Device: Energy Instruments Device: Stapling Device Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : June 9, 2018

Arm Intervention/treatment
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.
Device: Energy Instruments
Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

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.
Device: Stapling Device
Stapling Device, including linear stapler and curved stapler.




Primary Outcome Measures :
  1. Incidence rate of postoperative complications [ Time Frame: postoperative in-hospital stay up to 30 days ]

Secondary Outcome Measures :
  1. 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.

  2. Preoperative lung function [ Time Frame: Baseline. ]
  3. Postoperative lung function at the 3rd month after surgery [ Time Frame: at the 3rd month after surgery ]
  4. Postoperative hospital stay [ Time Frame: up to 24 weeks ]
  5. Postoperative ICU stay [ Time Frame: up to 24 weeks ]
  6. Duration of drainage [ Time Frame: up to 4 weeks ]
  7. Mortality in 30 days after surgery [ Time Frame: postoperative in-hospital stay up to 30 days ]
  8. Daily drainage volume [ Time Frame: During drainage time, up to 4 weeks ]
  9. Daily air leakage volume [ Time Frame: During drainage time, up to 4 weeks ]
  10. Duration of surgery [ Time Frame: During surgery ]
  11. Blood loss during surgery [ Time Frame: During surgery ]
  12. Conversive rate [ Time Frame: During surgery ]
  13. Pathological patterns [ Time Frame: 2 weeks after surgery ]
    Tumor location, pathological results, number of dissected lymph nodes, TMN stage.

  14. Medical costs [ Time Frame: During hospital stay, up to 24 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:
    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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192904


Locations
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China, Shanghai
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Hecheng Li, MD, PhD Ruijin Hospital
Principal Investigator: Xingshi Chen, MD Ruijin Hospital

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Responsible Party: Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03192904     History of Changes
Other Study ID Numbers: RuijinH-2017059
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hecheng Li M.D., Ph.D, Ruijin Hospital:
Lung cancer
Segmentectomy
Postoperative Complication
Stapling Device
Energy Device