Clinical trial NCT00795782: Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Official title: Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Cancer
Keywords: Papillary thyroid carcinoma
Lymph node dissection
Lymph node metastasis
Prophylactic node dissection
Central lymph node metastasis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.

Detailed description: The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.

Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.

Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.

Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.

Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)

Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis

Eligibility criteria: Inclusion Criteria:

* Age: 18 to 70
* Sonographically node-negative cytology confirmed thyroid papillary carcinoma
* Tumor size less than 1 cm in sonography
* Tumor confined to the one lobe of the thyroid gland
* One who provides the informed consent

Exclusion Criteria:

* History of radiation treatment to head and neck area
* History of other malignancy except thyroid cancer
* Poor performance status (ECOG 3-4)

Primary outcomes:
measure: Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
timeFrame: 3 year after initial treatment
Secondary outcomes:
measure: Postoperative complications(hypocalcemia, hoarseness)
timeFrame: up to 3 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
name: Han-Sin Jeong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Son YI, Jeong HS, Baek CH, Chung MK, Ryu J, Chung JH, So YK, Jang JY, Choi J. Extent of prophylactic lymph node dissection in the central neck area of the patients with papillary thyroid carcinoma: comparison of limited versus comprehensive lymph node dissection in a 2-year safety study. Ann Surg Oncol. 2008 Jul;15(7):2020-6. doi: 10.1245/s10434-008-9928-8. Epub 2008 May 6.