Clinical trial · Interventional
Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy
Comparison of LigaSure Technology to the Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery (VATS) Lobectomy Followed by Systemic Lymphadenectomy: A Prospective Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complication of Surgical Procedure | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LigaSure™ | Device | — | UNRESOLVED |
| Monopolar electrocautery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LigaSure
- description
- In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
- interventionNames
- Device: LigaSure™
- type
- ACTIVE_COMPARATOR
- label
- Monopolar electrocautery
- description
- In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
- interventionNames
- Device: Monopolar electrocautery
Primary outcomes (1)
- measure
- Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDLesser 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. PMID 23228409
- BACKGROUNDPiccinni 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;23:88-93. PMID 24081851
- BACKGROUNDLee 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. doi: 10.1002/bjs.4362. PMID 14648726
- BACKGROUNDBertolaccini L, Viti A, Cavallo A, Terzi A. Results of Li-Tho trial: a prospective randomized study on effectiveness of LigaSure(R) in lung resections. Eur J Cardiothorac Surg. 2014 Apr;45(4):693-8; discussion 698. doi: 10.1093/ejcts/ezt445. Epub 2013 Sep 12. PMID 24031044
- BACKGROUNDKuroda 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/jtd.2016.04.61. PMID 27293839
- DERIVEDGabryel P, Roszak M, Skrzypczak P, Gabryel A, Zielinska D, Sielewicz M, Campisi A, Kasprzyk M, Piwkowski C. Identification of Factors Related to the Quality of Lymphadenectomy for Lung Cancer: Secondary Analysis of Prospective Randomized Trial Data. J Clin Med. 2023 May 31;12(11):3780. doi: 10.3390/jcm12113780. PMID 37297976
- DERIVEDGabryel P, Kasprzyk M, Roszak M, Campisi A, Smolinski S, Zielinski P, Piwkowski C. Comparison of the LigaSure bipolar vessel sealer to monopolar electrocoagulation for thoracoscopic lobectomy and lymphadenectomy: a prospective randomized controlled trial. Surg Endosc. 2023 Jun;37(6):4449-4457. doi: 10.1007/s00464-023-09892-0. Epub 2023 Feb 15.