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Clinical Trials/NCT00591552
NCT00591552RecruitingNot Applicable

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

Sentara Cardiovascular Research Institute2 sites in 1 country50 target enrollmentStarted: December 1, 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Amount of chest tube drainage

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
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.
  • Patients with bulky or matted lymph nodes in stage 3A.
  • Current pregnancy.
  • Current participation in another study involving an investigational device or drug.

Outcomes

Primary Outcomes

Amount of chest tube drainage

Time Frame: daily

Secondary Outcomes

  • Pleural effusions monitored by chest x-ray.(Every other day and at four weeks)

Investigators

Sponsor
Sentara Cardiovascular Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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