Use of Harmonic Scalpel to Decrease Lymphatic and Chest T... | NCT00591552

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

NCT00591552

Sponsor

Sentara Cardiovascular Research Institute

Status

Unknown status

Last Update Posted

Nov 21, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

Harmonic ACE23P Scalpel
Electrocautery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SCRI-001

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Nov 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 21, 2023Actual

Name	Class
Ethicon Endo-Surgery	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Electrocautery used for dissection.	Device: Electrocautery
Group B	Active Comparator	Harmonic Scalpel used for dissection	Device: Harmonic ACE23P Scalpel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Harmonic ACE23P Scalpel	Device	Lymph node dissection	Group B
Electrocautery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of chest tube drainage		daily

Secondary Outcomes

Measure	Description	Time Frame
Pleural effusions monitored by chest x-ray.		Every other day and at four weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laura Pine, RN, BSN	Contact	757-388-2732		ljpine@sentara.com
Michelle Collier, RN, BSN	Contact	757-388-7511		mlcollie@sentara.com

Overall Officials

Name	Affiliation	Role
Joseph Newton, MD	Sentara Cardiovascular Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sentara Norfolk General Hospital/Sentara Heart Hospital	Recruiting	Norfolk	Virginia	23507	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12184902	Background	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.
14964555	Background	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.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D002425	Cautery
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative