Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.
Recruitment status was Recruiting
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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. |
- Amount of chest tube drainage [ Time Frame: daily ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Laura Pine, RN, BSN | 757-388-2732 | ljpine@sentara.com |
| Contact: Michelle Collier, RN, BSN | 757-388-7511 | mlcollie@sentara.com |
| 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 | |
| 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 May 19, 2013