Thyroid Cancer, PapillaryNCT02418390
The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma
A study testing prophylactic central lymph node dissection in people with Thyroid Cancer, Papillary, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Cancer, Papillary
- What is being tested?
- prophylactic central lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2015to 8 Oct 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 20 to 70 years old
- patients diagnosed with PTC or suspicious for PTC on fine needle aspiration or core needle biopsy
- patients with no evidence of LNM before and during surgery(cN0)
- patients with no evidence of distant metastasis(cM0).
Who cannot join
- patients suspected of advanced PTC(clinically T3 or T4) such as invasion of peripheral organs on preoperative examination
- patients who have previous history of cervical radiation therapy or surgery.
- pregnant women
- uncontrolled diabetes, hypertension, or chronic renal failure
- aspirin or anticoagulant medication within 7 days
- other clinical trial participation within 30 days
Show all 9Show fewer
- radiation exposure to the head and neck
- previous operation to the neck
- advanced thyroid cancer including adjacent organ invasion
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.
Read the detailed description
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of postoperative complications and PTC stage. The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).
- Conditions
- Thyroid Cancer, Papillary
- Being tested
- prophylactic central lymph node dissection
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic central lymph node dissectionProcedure or surgery
dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification
| Study group | Role | What they receive |
|---|---|---|
| No prophylactic central dissection | No intervention | Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection |
| Prophylactic central dissection | Active comparator | Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection Receives: Procedure: prophylactic central lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with successful surgical completeness
In the case of patients undergoing RAI ablation, surgical completeness was defined as cases with a negative ultrasonographic finding with postoperative 1st stimulated Tg <1 ng/mL.
In patients who did not undergo RAI treatment, the case with a negative finding at the 1st postoperative ultrasound with postoperative 1st unstimulated Tg <0.2ng/mL was defined as surgical completeness.
Measured: Participants will be followed from the operation to 5 year (maximum)
Recurrence rate of thyroid cancer
Recurrence was defined according to the definition of response to therapy in the 2015 American Thyroid Association(ATA) guidelines.
Measured: Participants will be followed from the operation to 5 year (maximum)
Number of participants with successful ablation
Successful ablation was defined as a patient whose stimulated Tg level was measured as <1 ng/mL at last ablation.
Measured: Participants will be followed from the operation to 5 year (maximum)
Secondary outcomes (2)
postoperative complication occurrence rate
At outpatient clinic (6months posteoperatively), video laryngoscopic exam and serum parathyroid hormone with serum calcium will be measured. Type and number of complications will be recorded
Measured: Participants will be followed from the operation to 5 year (maximum)
impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)
Postoperative complications was divided into transient complication (< 6 months) and permanent complication (≥ 6 months) according to the duration.
Hypoparathyroidism was diagnosed when patients were given oral calcium supplements to relieve symptoms of hypocalcemia or when serum parathyroid hormone (PTH) levels were lower than baseline values;1) PTH <10 pg/mL on days 1 and 14 after surgery; and 2) PTH <15 pg/mL at least 3 months after surgery.
All patients underwent a laryngeal ultrasound or laryngoscope after surgery to check for RLN injury. RLN injury was diagnosed when the vocal cord movement was hypomobile or fixed on evaluation. In addition, present study evaluated symptoms related to voice changes, such as hoarseness, thickened voice, difficulty in making high pitch sound, easy voice fatigue, aspiration, or dyspnea in an outpatient clinic.
Measured: TNM stage of each case was confirmed after final pathologic reports. At our facility, final pathologic reports would be turned out at an average of 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Cancer, PapillaryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Eun Lee, Seoul National University Hospital
- Investigators
- Kyu Eun Lee, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418390
- Sponsor's protocol ID
- H-1404-050-571
- Status last verified
- May 2022
- First submitted
- 7 Apr 2015
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Carling T, Carty SE, Ciarleglio MM, Cooper DS, Doherty GM, Kim LT, Kloos RT, Mazzaferri EL Sr, Peduzzi PN, Roman SA, Sippel RS, Sosa JA, Stack BC Jr, Steward DL, Tufano RP, Tuttle RM, Udelsman R; American Thyroid Association Surgical Affairs Committee. American Thyroid Association design and feasibility of a prospective randomized controlled trial of prophylactic central lymph node dissection for papillary thyroid carcinoma. Thyroid. 2012 Mar;22(3):237-44. doi: 10.1089/thy.2011.0317. Epub 2012 Feb 7.
PubMed 22313454
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT02418390
- Acronym / sponsor ID
- H-1404-050-571
- Conditions
- Thyroid Cancer, Papillary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 16 Apr 2015 (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 this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.
Detailed description
The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness, recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of postoperative complications and PTC stage. The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No prophylactic central dissection | No intervention | –Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection |
| Prophylactic central dissection | Active comparator | Procedure: prophylactic central lymph node dissectionPatients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged 20 to 70 years old
- patients diagnosed with PTC or suspicious for PTC on fine needle aspiration or core needle biopsy
- patients with no evidence of LNM before and during surgery(cN0)
- patients with no evidence of distant metastasis(cM0).
Key exclusion criteria (9 listed)
- patients suspected of advanced PTC(clinically T3 or T4) such as invasion of peripheral organs on preoperative examination
- patients who have previous history of cervical radiation therapy or surgery.
- pregnant women
- uncontrolled diabetes, hypertension, or chronic renal failure
- aspirin or anticoagulant medication within 7 days
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 |
|---|---|---|
| prophylactic central lymph node dissectiondissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification | Procedure or surgery | Prophylactic central dissection |
Primary outcome
The number of participants with successful surgical completeness
Time frame: Participants will be followed from the operation to 5 year (maximum)
In the case of patients undergoing RAI ablation, surgical completeness was defined as cases with a negative ultrasonographic finding with postoperative 1st stimulated Tg <1 ng/mL. In patients who did not undergo RAI treatment, the case with a negative finding at the 1st postoperative ultrasound with postoperative 1st unstimulated Tg <0.2ng/mL was defined as surgical completeness.
Recurrence rate of thyroid cancer
Time frame: Participants will be followed from the operation to 5 year (maximum)
Recurrence was defined according to the definition of response to therapy in the 2015 American Thyroid Association(ATA) guidelines.
Number of participants with successful ablation
Time frame: Participants will be followed from the operation to 5 year (maximum)
Successful ablation was defined as a patient whose stimulated Tg level was measured as <1 ng/mL at last ablation.
2 secondary outcomes
postoperative complication occurrence rate
Time frame: Participants will be followed from the operation to 5 year (maximum)
impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)
Time frame: TNM stage of each case was confirmed after final pathologic reports. At our facility, final pathologic reports would be turned out at an average of 2 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Results publication: PubMed 22313454Carling T, Carty SE, Ciarleglio MM, Cooper DS, Doherty GM, Kim LT, Kloos RT, Mazzaferri EL Sr, Peduzzi PN, Roman SA, Sippel RS, Sosa JA, Stack BC Jr, Steward DL, Tufano RP, Tuttle RM, Udelsman R; American Thyroid Association Surgical Affairs Committee. American Thyroid Association design and feasibility of a prospective randomized controlled trial of prophylactic central lymph node dissection for papillary thyroid carcinoma. Thyroid. 2012 Mar;22(3):237-44. doi: 10.1089/thy.2011.0317. Epub 2012 Feb 7.
- Individual participant dataSharing planned: No
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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.
Kyu Eun Lee, MD, PhD principal investigator
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic central lymph node dissection in people with Thyroid Cancer, Papillary, run by Seoul National University 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of participants with successful surgical completeness (time frame: Participants will be followed from the operation to 5 year (maximum)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418390, which also lists 1 linked publication.
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 1 Jun 2022.