The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma

NCT02418390 | Completed DMC

• 1 other identifier: H-1404-050-571
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

Conditions

Thyroid Cancer, Papillary

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Participants will be followed from the operation to 5 year (maximum)

Secondary Outcomes (2)

• postoperative complication occurrence rate

  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)

  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

Study Arms (2)

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

Procedure: prophylactic central lymph node dissection

Interventions

prophylactic central lymph node dissection PROCEDURE

dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification

Prophylactic central dissection

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• radiation exposure to the head and neck
• previous operation to the neck
• advanced thyroid cancer including adjacent organ invasion

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22313454 RESULT

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Kyu Eun Lee, MD, PhD

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 16, 2015
• Study Start: April 1, 2015
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)