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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Electrocautery used for dissection.

Group Type ACTIVE_COMPARATOR

Electrocautery

Intervention Type DEVICE

Group B

Harmonic Scalpel used for dissection

Group Type ACTIVE_COMPARATOR

Harmonic ACE23P Scalpel

Intervention Type DEVICE

Lymph node dissection

Interventions

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Harmonic ACE23P Scalpel

Lymph node dissection

Intervention Type DEVICE

Electrocautery

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No