Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy

NCT03125798 | Completed Results FDA Device

• 1 other identifier: TH-17-ML-1
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer; Complication of Surgical Procedure

Keywords

video-assisted thoracic surgery; LigaSure; mediastinal lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.

  Measurement of the postoperative volume of fluid drained in milliliters, measured up to chest drain removal, average 3 days.

  Total postoperative chest drainage volume

Secondary Outcomes (2)

• Acute Phase Proteins Levels.

  72 hours after surgery

• Local Temperature.

  During mediastinal lymph nodes dissection (during surgery)

Study Arms (2)

LigaSure

EXPERIMENTAL

In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.

Device: LigaSure™

Monopolar electrocautery

ACTIVE COMPARATOR

In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.

Device: Monopolar electrocautery

Interventions

LigaSure™ DEVICE

LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.

LigaSure

Monopolar electrocautery DEVICE

Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.

Monopolar electrocautery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii: lead
• Medtronic: collaborator

Study Sites (1)

Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Poznan, Wielkopolska, 62-007, Poland

Location

Related Publications (7)

• 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.

  PMID: 23228409 BACKGROUND

• 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;23:88-93.

  PMID: 24081851 BACKGROUND

• 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. doi: 10.1002/bjs.4362.

  PMID: 14648726 BACKGROUND

• Bertolaccini 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 BACKGROUND

• 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/jtd.2016.04.61.

  PMID: 27293839 BACKGROUND

• Gabryel 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 DERIVED

• Gabryel 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.

  PMID: 36792782 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

It was not possible to conceal the type of intervention - dissection with LigaSure versus monopolar device - from the surgeons who performed the operations. Methodological limitations may have resulted in the non-detection of the differences in intra-esophageal temperature and energy-dissipation-related complications between the groups.

Results Point of Contact

• Title: Dr Piotr Gabryel
• Organization: Wielkoposkie Centrum Pulmonologii i Torakochirurgii

piotrgabryel@gmail.com

+48616654249

Study Officials

• Cezary Piwkowski, Prof

  Wielkopolskie Centrum Pulmonologii i Torakochirurgii

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: May 3, 2018
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)