Thyroid NeoplasmNCT01103557
Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma
A study testing prophylactic selective lateral neck dissection in people with Thyroid Neoplasm and Lymphatic Metastasis, run by Pusan National University Hospital.
Trial summary
The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND). Read more about this study
- Who is it for?
- Ages 20 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Neoplasm, Lymphatic Metastasis
- What is being tested?
- prophylactic selective lateral neck dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Papillary thyroid carcinoma with central neck metastasis
- No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography
Who cannot join
- History of previous thyroid operation
- Isthmic thyroid lesion
About this study
Official title: The Effectiveness of Prophylactic Selective Lateral Neck Dissection in Papillary Thyroid Carcinoma Patients With Central Neck Metastasis
The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).
Read the detailed description
The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.
- Conditions
- Thyroid Neoplasm, Lymphatic Metastasis
- Being tested
- prophylactic selective lateral neck dissection
- Keywords
- Papillary thyroid carcinoma with neck metastasis, neck dissection
- Medical subject headings
- Thyroid Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic selective lateral neck dissectionProcedure or surgery
Level II, III, IV lymph node dissection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103557
- Sponsor's protocol ID
- PTC_CND_LND
- Status last verified
- Jan 2010
- First submitted
- 12 Apr 2010
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Prophylactic Selective Lateral Neck Dissection in Papillary Thyroid Carcinoma Patients With Central Neck Metastasis
- ClinicalTrials.gov ID
- NCT01103557
- Acronym / sponsor ID
- PTC_CND_LND
- Conditions
- Thyroid Neoplasm, Lymphatic Metastasis
- Keywords
- Papillary thyroid carcinoma with neck metastasis, neck dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- First posted
- 14 Apr 2010 (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 purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).
Detailed description
The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Papillary thyroid carcinoma with central neck metastasis
- No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography
Key exclusion criteria (2 listed)
- History of previous thyroid operation
- Isthmic thyroid lesion
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 selective lateral neck dissectionLevel II, III, IV lymph node dissection | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 14 Apr 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing prophylactic selective lateral neck dissection in people with Thyroid Neoplasm and Lymphatic Metastasis, run by Pusan National University Hospital.
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 2 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 14 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 14 Apr 2010.