Clinical trial NCT02418390: The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma
Official title: The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer, Papillary
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: Inclusion criteria were as follows:

1. patients aged 20 to 70 years old
2. patients diagnosed with PTC or suspicious for PTC on fine needle aspiration or core needle biopsy
3. patients with no evidence of LNM before and during surgery(cN0)
4. patients with no evidence of distant metastasis(cM0).

Exclusion criteria were as follows:

1. patients suspected of advanced PTC(clinically T3 or T4) such as invasion of peripheral organs on preoperative examination
2. patients who have previous history of cervical radiation therapy or surgery.
3. pregnant women
4. uncontrolled diabetes, hypertension, or chronic renal failure
5. aspirin or anticoagulant medication within 7 days
6. other clinical trial participation within 30 days
7. radiation exposure to the head and neck
8. previous operation to the neck
9. advanced thyroid cancer including adjacent organ invasion

Primary outcomes:
measure: The number of participants with successful surgical completeness
timeFrame: Participants will be followed from the operation to 5 year (maximum)
measure: Recurrence rate of thyroid cancer
timeFrame: Participants will be followed from the operation to 5 year (maximum)
measure: Number of participants with successful ablation
timeFrame: Participants will be followed from the operation to 5 year (maximum)
Secondary outcomes:
measure: postoperative complication occurrence rate
timeFrame: Participants will be followed from the operation to 5 year (maximum)
measure: impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Kyu Eun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.