search
Back to results

Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System (UCBEST)

Primary Purpose

Thyroid Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasonic coagulation device (Harmonic ACE® scalpel)
bipolar energy sealing system (LigaSure Precise)
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring operation time, complication rate, costs, admission time, RFS, OS

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy
  2. patients who are agree with the study enrollment

Exclusion Criteria:

  1. an age under 20 or over 80 years
  2. severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems)
  3. a lack of consent to participate in the study
  4. the inability to include a patient in clinical trials according to the regulations or laws in Korea
  5. the inability to complete regular follow-up visits (e.g., immigration)
  6. the use of modified radical neck dissection due to lateral neck node metastasis
  7. prior thyroid surgery or cervical irradiation
  8. active enrollment in another clinical trial
  9. the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time)
  10. the desire to undergo endoscopic or robot-assisted thyroidectomy

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ultrasonic coagulation device

Bipolar Energy Sealing System

Arm Description

Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy

Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy

Outcomes

Primary Outcome Measures

operation time
from skin incision to skin closure

Secondary Outcome Measures

postoperative complications
postoperative drainage volume
admission time
Cost
Relapse-free survival (RFS)
Overall Survival (OS)

Full Information

First Posted
September 2, 2011
Last Updated
December 4, 2012
Sponsor
Seoul St. Mary's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01565486
Brief Title
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System
Acronym
UCBEST
Official Title
Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated With the Harmonic ACE® Scalpel and LigaSure Precise™ Instrument During Conventional Thyroidectomy: A Single-blind Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer. Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)
Detailed Description
Background: Thyroid is an organ that has abundant vessels. In thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. Recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. UC and BES are now commonly used in thyroid surgery. However, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. Thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (RFS and OS) between the two surgical devices in surgery for thyroid cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
operation time, complication rate, costs, admission time, RFS, OS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonic coagulation device
Arm Type
Other
Arm Description
Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
Arm Title
Bipolar Energy Sealing System
Arm Type
Other
Arm Description
Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
Intervention Type
Device
Intervention Name(s)
Ultrasonic coagulation device (Harmonic ACE® scalpel)
Other Intervention Name(s)
Harmonic ACE® scalpel
Intervention Description
Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
Intervention Type
Device
Intervention Name(s)
bipolar energy sealing system (LigaSure Precise)
Other Intervention Name(s)
LigaSure Precise instrument
Intervention Description
Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
Primary Outcome Measure Information:
Title
operation time
Description
from skin incision to skin closure
Time Frame
from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery
Secondary Outcome Measure Information:
Title
postoperative complications
Time Frame
at 3 hours, 1, 2, 3, 10 days and 1 months after surgery and 6 months and every 1 years after surgery
Title
postoperative drainage volume
Time Frame
estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
Title
admission time
Time Frame
documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
Title
Cost
Time Frame
documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
Title
Relapse-free survival (RFS)
Time Frame
from date of surgery until date of first documented recurrence or date of death from any cause, whichever came first, accessed up to 60 months
Title
Overall Survival (OS)
Time Frame
from date of surgery until date of death from any cause, accessed up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy patients who are agree with the study enrollment Exclusion Criteria: an age under 20 or over 80 years severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems) a lack of consent to participate in the study the inability to include a patient in clinical trials according to the regulations or laws in Korea the inability to complete regular follow-up visits (e.g., immigration) the use of modified radical neck dissection due to lateral neck node metastasis prior thyroid surgery or cervical irradiation active enrollment in another clinical trial the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time) the desire to undergo endoscopic or robot-assisted thyroidectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ja Seong Bae, MD,phD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seocho-gu
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System

We'll reach out to this number within 24 hrs