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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Sentara Cardiovascular Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Sentara Cardiovascular Research Institute
ClinicalTrials.gov Identifier:
NCT00591552
First received: December 26, 2007
Last updated: January 10, 2008
Last verified: December 2007
  Purpose

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.


Condition Intervention
Lung Cancer
Device: Harmonic ACE23P Scalpel
Device: Electrocautery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy. A Single Center Prospective Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by Sentara Cardiovascular Research Institute:

Primary Outcome Measures:
  • Amount of chest tube drainage [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pleural effusions monitored by chest x-ray. [ Time Frame: Every other day and at four weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591552

Contacts
Contact: Laura Pine, RN, BSN 757-388-2732 ljpine@sentara.com
Contact: Michelle Collier, RN, BSN 757-388-7511 mlcollie@sentara.com

Locations
United States, Virginia
Sentara Norfolk General Hospital/Sentara Heart Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Laura Pine, RN, BSN    757-388-2732    ljpine@sentara.com   
Contact: Michelle Collier, RN, BSN    757-388-7511    mlcollie@sentara.com   
Sub-Investigator: Kirk Fleischer, MD         
Sub-Investigator: Michael McGrath, MD         
Sub-Investigator: Jeffrey Rich, MD         
Sponsors and Collaborators
Sentara Cardiovascular Research Institute
Ethicon Endo-Surgery
Investigators
Principal Investigator: Joseph Newton, MD Sentara Cardiovascular Research Institute
  More Information

Publications:
Responsible Party: Joseph Newton, MD, Sentara Cardiovascular Research Institute
ClinicalTrials.gov Identifier: NCT00591552     History of Changes
Other Study ID Numbers: SCRI-001, SCRI-001
Study First Received: December 26, 2007
Last Updated: January 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Sentara Cardiovascular Research Institute:
Lung cancer
Lymph node dissection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014