Lung Cancer Clinical Trial
Official title:
Comparison of LigaSure Technology to the Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery (VATS) Lobectomy Followed by Systemic Lymphadenectomy: A Prospective Randomized Controlled Study
NCT number | NCT03125798 |
Other study ID # | TH-17-ML-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2018 |
Est. completion date | November 4, 2021 |
Verified date | November 2021 |
Source | Wielkopolskie Centrum Pulmonologii i Torakochirurgii |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgical treatment of lung cancer consists of two elements: anatomical lung resection (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node dissection (MLND). Since over last 15 years the growing rate of resection is performed by minimal invasive approach - video-assisted thoracoscopic surgery (VATS). The study is focused on the clinical and technical aspects of MLND during VATS lobectomy. The extension of lymph nodes resection is strictly specified. The main benefit of MLND for the patient is precise histopathological staging, which allows choosing the best therapeutic option of adjuvant therapy. MLND is related with potential minor and major complications (bleeding, increased volume of chest tube drainage, prolonged chest tube duration and hospital stay, chylothorax, left recurrent laryngeal nerve injury, injury of the bronchus, injury of the esophagus). The majority of complications are caused by thermal injury resulting from the use of heat-generating monopolar electrocautery that is commonly used during lymph nodes dissection. In addition, thermal energy generation in case of monopolar electrocautery may lead to systemic inflammatory response and increased surgical injury. High-energy sealing devices like LigaSure™ allow for dissection, coagulation and cutting with the single instrument. Compared to mechanical ligation techniques (vessel loops, clips) or monopolar electrocautery, LigaSure™ technology has been shown to reduce: intraoperative blood loss (in colorectal, gynecologic and urologic surgery), surgery time (in colorectal, gynecologic and urologic surgery), length of hospital stay (in gynecologic and urologic surgery). Investigators hypothesize that application of LigaSure™ in VATS anatomical resection may lead to diminished complications rate, lower systemic inflammatory response and shorter length of stay compared to monopolar electrocautery.
Status | Completed |
Enrollment | 215 |
Est. completion date | November 4, 2021 |
Est. primary completion date | November 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Surgery performed by Video-Assisted Thoracic Surgery technique (VATS). - Mediastinal Lymph Node Dissection performed due to the European Society of Thoracic Surgeons - Patients must be informed and must sign and give written informed consent. Exclusion Criteria: - Preoperative radiotherapy. - Preoperative chemotherapy. - Mediastinoscopy or other surgical procedures of mediastinum prior to the present surgery. - Chest surgery on the side to be operated. - Conversion from VATS to thoracotomy |
Country | Name | City | State |
---|---|---|---|
Poland | Wielkopolskie Centrum Pulmonologii i Torakochirurgii | Poznan | Wielkopolska |
Lead Sponsor | Collaborator |
---|---|
Wielkopolskie Centrum Pulmonologii i Torakochirurgii | Medtronic |
Poland,
Bertolaccini L, Viti A, Cavallo A, Terzi A. Results of Li-Tho trial: a prospective randomized study on effectiveness of LigaSure® in lung resections. Eur J Cardiothorac Surg. 2014 Apr;45(4):693-8; discussion 698. doi: 10.1093/ejcts/ezt445. Epub 2013 Sep 1 — View Citation
Kuroda H, Dejima H, Mizumo T, Sakakura N, Sakao Y. A new LigaSure technique for the formation of segmental plane by intravenous indocyanine green fluorescence during thoracoscopic anatomical segmentectomy. J Thorac Dis. 2016 Jun;8(6):1210-6. doi: 10.21037 — View Citation
Lee WJ, Chen TC, Lai IR, Wang W, Huang MT. Randomized clinical trial of Ligasure versus conventional surgery for extended gastric cancer resection. Br J Surg. 2003 Dec;90(12):1493-6. — View Citation
Lesser TG, Wolfram F, Boltze C. Sealing of pulmonary arteries with LigaSure: in vivo and ex vivo examinations. J Thorac Cardiovasc Surg. 2013 Jun;145(6):1525-8. doi: 10.1016/j.jtcvs.2012.11.009. Epub 2012 Dec 8. — View Citation
Piccinni G, Pasculli A, D'Ambrosio E, Gurrado A, Lissidini G, Testini M. Retrospective comparison of Traditional vs. LigaSure impact dissection during pancreatoduodenectomy: how to save money by using an expensive device. Surg Technol Int. 2013 Sep;23:88- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative chest drainage volume. | Measurement of the postoperative volume of fluid drained in milliliters. | Up to 3 days after surgery. | |
Secondary | Acute phase proteins levels. | Measurement of changes in acute phase proteins levels that correlate to systemic inflammatory response, between baseline value (24 hours before surgery) and maximal value (72 hours after surgery) | 24 hours before surgery, 72 hours after surgery | |
Secondary | Local temperature. | Measurement of temperature of tissues adjacent to subcarinal lymph nodes during monopolar electrocautery or LigaSure use. | During mediastinal lymph nodes dissection (during surgery) |
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