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

Thyroid Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01565486
• Other study ID #: KC11DISI0534
• Status: Active, not recruiting
• Phase: N/A
• First received: September 2, 2011
• Last updated: December 4, 2012
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: December 2012
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 304
• Est. completion date: August 2017
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Device:
• Ultrasonic coagulation device (Harmonic ACE® scalpel)
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
• bipolar energy sealing system (LigaSure Precise)
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seocho-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	from skin incision to skin closure	from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery	No
Secondary	postoperative complications		at 3 hours, 1, 2, 3, 10 days and 1 months after surgery and 6 months and every 1 years after surgery	No
Secondary	postoperative drainage volume		estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery	No
Secondary	admission time		documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery	No
Secondary	Cost		documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery	No
Secondary	Relapse-free survival (RFS)		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	No
Secondary	Overall Survival (OS)		from date of surgery until date of death from any cause, accessed up to 60 months	No