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


N/A
20 Years
75 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Amount of chest tube drainage

Outcome Time Frame:

daily

Safety Issue:

No

Principal Investigator

Joseph Newton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sentara Cardiovascular Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI-001

NCT ID:

NCT00591552

Start Date:

December 2007

Completion Date:

August 2009

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Lymph node dissection
  • Lung Neoplasms

Name

Location

Sentara Norfolk General Hospital/Sentara Heart HospitalNorfolk, Virginia  23507