Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.

Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy. A Single Center Prospective Randomized Controlled Study.

In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and decrease lymphatic drainage thereby decreasing the length of time that chest tubes are required and minimizing length of stay; the Harmonic Scalpel will be compared to a control group which uses electrocautery. This study will assess these two different methods to determine if there is a notable decrease in the amount of drainage with one versus the other.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Electrocautery; Device: Harmonic ACE23P Scalpel

Detailed Description

Lymph node dissection is an integral part of the surgical management of lung cancer. Knowledge of lymph node status plays a key role in therapeutic decision making and prognosis. Associated with this dissection comes the propensity for lymphatic leakage, increased chest tube drainage, prolonged retention of chest tubes in the postoperative period and increased patient length of stay. Our center performs complete mediastinal node dissection of all relevant regional lymph nodes which generally include paratracheal, pretracheal, subcarinal, hilar and paraesophageal nodes. The current standard of practice for the dissection of the lymph nodes includes the use of the Harmonic Scalpel or electrocautery. Known risk of electrocautery include localized nerve damage, cardiac arrhythmias and damage to the tissue sample/specimen that is used for pathology. The Harmonic Scalpel technology has recently become available for use. Current experience with the Harmonic Scalpel suggests that there is less localized nerve damage, less incidence of arrhythmias, less damage to the tissue sample and less lymph leakage. There is no published data to support this hypothesis, thus the purpose of this study.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Pine, RN, BSN; Phone Number: 757-388-2732; Email: ljpine@sentara.com
• Study Contact Backup: Name: Michelle Collier, RN, BSN; Phone Number: 757-388-7511; Email: mlcollie@sentara.com

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital/Sentara Heart Hospital
      • Contact: Laura Pine, RN, BSN; Phone Number: 757-388-2732; Email: ljpine@sentara.com
      • Contact: Michelle Collier, RN, BSN; Phone Number: 757-388-7511; Email: mlcollie@sentara.com
      • Sub-Investigator: Kirk Fleischer, MD
      • Sub-Investigator: Michael McGrath, MD
      • Sub-Investigator: Jeffrey Rich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing resection for stage 1, 2 or 3A lung cancer.
• Patients between the ages of 20-75.

Exclusion Criteria:

• History of Congestive Heart Failure.
• History of renal failure, ie., creatinine greater than 2.2.
• Patients with bulky or matted lymph nodes in stage 3A.
• Current pregnancy.
• Current participation in another study involving an investigational device or drug.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Electrocautery used for dissection.	Device: Electrocautery
Active Comparator: Group B; Harmonic Scalpel used for dissection	Device: Harmonic ACE23P Scalpel; Lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of chest tube drainage	daily

Secondary Outcome Measures

Outcome Measure	Time Frame
Pleural effusions monitored by chest x-ray.	Every other day and at four weeks

Collaborators and Investigators

• Sponsor: Sentara Cardiovascular Research Institute
• Collaborators: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Joseph Newton, MD, Sentara Cardiovascular Research Institute

Publications and helpful links

General Publications

• Holub Z, Jabor A, Kliment L, Lukac J, Voracek J. Laparoscopic lymph node dissection using ultrasonically activated shears: comparison with electrosurgery. J Laparoendosc Adv Surg Tech A. 2002 Jun;12(3):175-80. doi: 10.1089/10926420260188065.
• Lumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4.
• Kajiyama Y, Iwanuma Y, Tomita N, Amano T, Hattori K, Tsurumaru M. Sealing the thoracic duct with ultrasonic coagulating shears. Hepatogastroenterology. 2005 Jul-Aug;52(64):1053-6.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (Estimated): January 11, 2008

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lung cancer; Lymph node dissection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SCRI-001