Thyroid CancerUCBESTNCT01565486
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System
A study testing Ultrasonic coagulation device (Harmonic ACE® scalpel) and bipolar energy sealing system (LigaSure Precise) in people with Thyroid Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Ultrasonic coagulation device (Harmonic ACE® scalpel) and bipolar energy sealing system (LigaSure Precise)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Conditions
- Thyroid Cancer
- Being tested
- Ultrasonic coagulation device (Harmonic ACE® scalpel), bipolar energy sealing system (LigaSure Precise)
- Keywords
- operation time, complication rate, costs, admission time, RFS, OS
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic coagulation device (Harmonic ACE® scalpel)Device
Also called 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)Device
Also called LigaSure Precise instrument
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
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic coagulation device | Other | 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 Receives: Device: Ultrasonic coagulation device (Harmonic ACE® scalpel) |
| Bipolar Energy Sealing System | Other | 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 Receives: Device: bipolar energy sealing system (LigaSure Precise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
from skin incision to skin closure
Measured: from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery
Secondary outcomes (6)
postoperative complications
Measured: at 3 hours, 1, 2, 3, 10 days and 1 months after surgery and 6 months and every 1 years after surgery
postoperative drainage volume
Measured: estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery
admission time
Measured: documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
Cost
Measured: documented when the patient leaves the hospital at an average time of 5 to 10 days according to the extent of surgery
Relapse-free survival (RFS)
Measured: 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
Overall Survival (OS)
Measured: from date of surgery until date of death from any cause, accessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2013 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital
- Investigators
- Ja Seong Bae, MD,phD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565486
- Sponsor's protocol ID
- KC11DISI0534
- Acronym
- UCBEST
- Status last verified
- Dec 2012
- First submitted
- 2 Sep 2011
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01565486
- Acronym / sponsor ID
- UCBEST / KC11DISI0534
- Conditions
- Thyroid Cancer
- Keywords
- operation time, complication rate, costs, admission time, RFS, OS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic coagulation device | Other | 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 | Other | Device: 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic coagulation device (Harmonic ACE® scalpel)Also: Harmonic ACE® scalpelComparison 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 | Device | Ultrasonic coagulation device |
| bipolar energy sealing system (LigaSure Precise)Also: LigaSure Precise instrumentComparison 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 | Device | Bipolar Energy Sealing System |
Primary outcome
operation time
Time frame: from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery
from skin incision to skin closure
6 secondary outcomes
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
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
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
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
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
Overall Survival (OS)
Time frame: from date of surgery until date of death from any cause, accessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ja Seong Bae, MD,phD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic coagulation device (Harmonic ACE® scalpel) and bipolar energy sealing system (LigaSure Precise) in people with Thyroid Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: from skin incision to skin closure at an average time of 60 min to 160 min according to the extent of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.