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

August 7, 2024 updated by: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Comparison of LigaSure Technology to the Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery (VATS) Lobectomy Followed by Systemic Lymphadenectomy: A Prospective Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Summary

Surgical treatment of lung cancer consists of two elements: anatomical lung resection (segmentectomy, lobectomy or pneumonectomy) followed by mediastinal lymph node sampling (MLNS) or 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). This technique is used in at least 60% of patients with lung cancer operated on in the leading centers. The study project is focused on the clinical and technical aspects of MLNS/MLND during VATS lobectomy. Lymphadenectomy has to be performed obligatory in case of lung cancer resection. The extension of lymph nodes resection or sampling is strictly specified and should be the same independently from the surgical approach (thoracotomy or VATS). The main benefit of MLNS/MLND for the patient is precise histopathological staging, which allows choosing the best therapeutic option of adjuvant therapy. It was proved that MLND is superior to MLNS in its accuracy however the improvement of local control of the disease is not proved.

Mediastinal lymphadenectomy is related with potential minor and major complications. The risk of complications is low but in case of their occurrence hospital stay is usually significantly prolonged, quality of life decreases and additional surgery may be needed. In very small group of patients complications may lead to severe disability or death.

The most frequent complications related with MLND are:

  1. Bleeding, sometimes requiring redo surgery;
  2. Increased volume of chest tube drainage with prolonged chest tube duration and hospital stay;
  3. Chylothorax;
  4. Left recurrent laryngeal nerve injury;
  5. Injury of the bronchus (especially of posterior part of right main bronchus during dissection of subcarinal lymph nodes);
  6. Injury of the esophagus (dissection of subcarinal and paraesophageal lymph nodes).

The majority of the above mentioned complications are caused by thermal injury resulting from the use of heat-generating monopolar electrocautery that is commonly used during lymph nodes dissection. Bleeding or chylothorax are usually caused by incomplete blood or lymphatic vessels closure. Esophageal or bronchial wall injury can be caused by thermal injury followed by ischemia, necrosis and finally perforation. The diagnosis is frequently delayed. In addition, thermal energy generation in case of monopolar electrocautery may lead to systemic inflammatory response and increased surgical injury. Extent of surgical injury measured by acute phase proteins levels (c-reactive protein, alpha-1-antitrypsin, alpha-1-acid glycoprotein, haptoglobin) and interleukin levels was proved to be correlated to long-term results in patients with colorectal cancer.

Introduction of new high-energy sealing devices like LigaSure™ to clinical practice allows 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 significantly reduce:

  • Operative blood loss in colorectal, gynecologic and urologic surgery
  • Perioperative blood transfusions in gynecologic, urologic and general surgery
  • Procedure time in colorectal, gynecologic and urologic surgery
  • Length of hospital stay in gynecologic and urologic surgery.

There have been no randomized studies comparing the use of traditional electrocautery and LigaSure for lymphadenectomy during VATS resection due to non-small cell lung cancer.

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.

Study design

Patients with early stage NSCLC who are routinely operated on by VATS will be randomized into two groups. First group called electro-VATS (Monopolar electrocautery) will be operated on with the use of traditional electrocautery and the second called liga-VATS (LigaSure) with the use of LigaSure. In the first group during the whole procedure (dissection of pulmonary ligament, mediastinal pleura and adhesions, as well as hilar dissection and lymphadenectomy) only traditional monopolar electrocautery will be used. In the liga-VASTS patients only LigaSure will be applied,no monopolar electrocautery will be used. The procedure of VATS lobectomy or segmentectomy will be performed in standardized fashion with separate stapling of hilar vessels and bronchus and lung parenchyma division. The hilar dissection and mediastinal lymphadenectomy will be performed using either monopolar electrocautery or LigaSure according to the randomization. The extent of lymphadenectomy will be the same in both groups and will include stations 2R,4R,7,8R,9R,10R,11R on the right side and stations 5,6,7,8L,9L,10L,11L on the left side. The number of removed lymph nodes will be counted. The extension of lymphadenectomy will be controlled and supervised by main investigator. Deep temperature inside the esophagus at the level approximately 2-3 cm below the carina will be measured during lymphadenectomy in order to assess the differences in the exposure of the surrounding tissues to the thermal energy generated by either LigaSure or electrocautery. The temperature measurement should in some part reflect the potential risk of thermal injury to the esophagus caused by different energy devices.

Investigators plan to enroll 200 patients, 100 patients in each group. Initial assessment will include age, gender, comorbidities (Charlson Comorbidity Index, CCI and Thoracic Revised Cardiac Risk Index, thRCRI scores) and pulmonary function tests. The following factors/parameters will be measured/compared in both groups: 24-hour, 48-hour and total volume of chest tube drainage, chest tube duration and hospital stay, rate of the prolonged air leak, rate of redo surgery due to bleeding, rate of postoperative complications related to the procedure, intraoperative blood loss and time of the surgery, local thermal effect, systemic inflammatory response after surgery.

Statistical analysis

The analyzed data will be presented as means, standard deviations, minimum and maximum values, medians, interquartile ranges (lower quartile, upper quartile) or percentage, as appropriate. Normality of the distribution will be tested with the Shapiro-Wilk's test, and the equality of variances will be checked with the Levene's test. For comparison of groups, unpaired t test or one-way ANOVA (for data which follow normal distribution and homogeneity of variances) or Welch test will be applied. In case data will not normally distributed nonparametric tests will be used - Mann-Whitney U test or the Kruskal-Wallis test with the Dunn's post-hoc test. Categorical data will be analyzed with the χ2 test or the Fisher-Freeman-Halton test. The relationship between variables will be analyzed with the Pearson's linear correlation coefficient or the Spearman's rank correlation coefficient or (and) by multivariate linear regression. All the results will be considered significant at p<0.05. Statistical analyses will be performed with statistical packages: STATISTICA 10.0 PL (StatSoft. Inc.) or StatXact 9.0 (CytelStudio) software.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Wielkopolska
      • Poznań, Wielkopolska, Poland, 62-007
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LigaSure
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Device: LigaSure™
LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
Active Comparator: Monopolar electrocautery
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Device: Monopolar electrocautery
Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.
Time Frame: Total postoperative chest drainage volume
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Phase Proteins Levels.
Time Frame: 72 hours after surgery
Change in C-reactive protein (CRP) level, calculated as the difference between CRP values [mg/L] at 72 hours after surgery and 24 hours before surgery
72 hours after surgery
Local Temperature.
Time Frame: During mediastinal lymph nodes dissection (during surgery)
Change in the intraesophageal temperature at the level of the subcarinal lymph nodes, calculated as the difference between the highest temperature during subcarinal nodes dissection and the temperature before subcarinal nodes dissection
During mediastinal lymph nodes dissection (during surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cezary Piwkowski, Prof, Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TH-17-ML-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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