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

Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00591552
• Other study ID #: SCRI-001
• Secondary ID: SCRI-001
• Status: Recruiting
• Phase: N/A
• Start date: December 2007
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Sentara Cardiovascular Research Institute
• Contact: Laura Pine, RN, BSN
• Phone: 757-388-2732
• Email: ljpine[@]sentara.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• Harmonic ACE23P Scalpel
Lymph node dissection
• Electrocautery

Locations

Country	Name	City	State
United States	Sentara Norfolk General Hospital/Sentara Heart Hospital	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Sentara Cardiovascular Research Institute	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

References & Publications (3)

Holub Z, Jabor A, Kliment L, Lukac J, Voracek J. Laparoscopic lymph node dissection using ultrasonically activated shears: comparison with electrosurgery. J Laparoendosc Adv Surg Tech A. 2002 Jun;12(3):175-80. doi: 10.1089/10926420260188065. — View Citation

Kajiyama Y, Iwanuma Y, Tomita N, Amano T, Hattori K, Tsurumaru M. Sealing the thoracic duct with ultrasonic coagulating shears. Hepatogastroenterology. 2005 Jul-Aug;52(64):1053-6. — View Citation

Lumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of chest tube drainage		daily
Secondary	Pleural effusions monitored by chest x-ray.		Every other day and at four weeks