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Trial Title:
Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.
NCT ID:
NCT00591552
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer
Lymph node dissection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Harmonic ACE23P Scalpel
Description:
Lymph node dissection
Arm group label:
Group B
Intervention type:
Device
Intervention name:
Electrocautery
Arm group label:
Group A
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sentara Norfolk General Hospital/Sentara Heart Hospital
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura Pine, RN, BSN
Phone:
757-388-2732
Email:
ljpine@sentara.com
Contact backup:
Last name:
Michelle Collier, RN, BSN
Phone:
757-388-7511
Email:
mlcollie@sentara.com
Investigator:
Last name:
Kirk Fleischer, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michael McGrath, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jeffrey Rich, MD
Email:
Sub-Investigator
Start date:
December 2007
Completion date:
November 2024
Lead sponsor:
Agency:
Sentara Cardiovascular Research Institute
Agency class:
Other
Collaborator:
Agency:
Ethicon Endo-Surgery
Agency class:
Industry
Source:
Sentara Cardiovascular Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00591552
