search
Back to results

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

Primary Purpose

Thyroid Cancer, Papillary

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
prophylactic central lymph node dissection
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer, Papillary

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No prophylactic central dissection

Prophylactic central dissection

Arm Description

Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection

Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection

Outcomes

Primary Outcome Measures

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.
Recurrence rate of thyroid cancer
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
Successful ablation was defined as a patient whose stimulated Tg level was measured as <1 ng/mL at last ablation.

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 7, 2015
Last Updated
May 30, 2022
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02418390
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Papillary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No prophylactic central dissection
Arm Type
No Intervention
Arm Description
Patients underwent total thyroidectomy for papillary thyroid carcinoma, without prophylactic central lymph node dissection
Arm Title
Prophylactic central dissection
Arm Type
Active Comparator
Arm Description
Patients underwent total thyroidectomy for papillary thyroid carcinoma, with prophylactic central lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
prophylactic central lymph node dissection
Intervention Description
dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification
Primary Outcome Measure Information:
Title
The number of participants with successful surgical completeness
Description
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.
Time Frame
Participants will be followed from the operation to 5 year (maximum)
Title
Recurrence rate of thyroid cancer
Description
Recurrence was defined according to the definition of response to therapy in the 2015 American Thyroid Association(ATA) guidelines.
Time Frame
Participants will be followed from the operation to 5 year (maximum)
Title
Number of participants with successful ablation
Description
Successful ablation was defined as a patient whose stimulated Tg level was measured as <1 ng/mL at last ablation.
Time Frame
Participants will be followed from the operation to 5 year (maximum)
Secondary Outcome Measure Information:
Title
postoperative complication occurrence rate
Description
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
Time Frame
Participants will be followed from the operation to 5 year (maximum)
Title
impact of prophylactic central lymph node dissection on staging of papillary thyroid cancer(PTC)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria were as follows: 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). Exclusion criteria were as follows: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Eun Lee, MD, PhD
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22313454
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs