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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harmonic ACE23P Scalpel
Electrocautery
Sponsored by
Sentara Cardiovascular Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, Lymph node dissection

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sentara Norfolk General Hospital/Sentara Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Electrocautery used for dissection.

Harmonic Scalpel used for dissection

Outcomes

Primary Outcome Measures

Amount of chest tube drainage

Secondary Outcome Measures

Pleural effusions monitored by chest x-ray.

Full Information

First Posted
December 26, 2007
Last Updated
October 25, 2022
Sponsor
Sentara Cardiovascular Research Institute
Collaborators
Ethicon Endo-Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00591552
Brief Title
Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sentara Cardiovascular Research Institute
Collaborators
Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Lymph node dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Electrocautery used for dissection.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Harmonic Scalpel used for dissection
Intervention Type
Device
Intervention Name(s)
Harmonic ACE23P Scalpel
Intervention Description
Lymph node dissection
Intervention Type
Device
Intervention Name(s)
Electrocautery
Primary Outcome Measure Information:
Title
Amount of chest tube drainage
Time Frame
daily
Secondary Outcome Measure Information:
Title
Pleural effusions monitored by chest x-ray.
Time Frame
Every other day and at four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Pine, RN, BSN
Phone
757-388-2732
Email
ljpine@sentara.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Collier, RN, BSN
Phone
757-388-7511
Email
mlcollie@sentara.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Newton, MD
Organizational Affiliation
Sentara Cardiovascular Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sentara Norfolk General Hospital/Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Pine, RN, BSN
Phone
757-388-2732
Email
ljpine@sentara.com
First Name & Middle Initial & Last Name & Degree
Michelle Collier, RN, BSN
Phone
757-388-7511
Email
mlcollie@sentara.com
First Name & Middle Initial & Last Name & Degree
Kirk Fleischer, MD
First Name & Middle Initial & Last Name & Degree
Michael McGrath, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey Rich, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12184902
Citation
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.
Results Reference
background
PubMed Identifier
14964555
Citation
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.
Results Reference
background
PubMed Identifier
16001628
Citation
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.
Results Reference
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Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.

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