UMIN-ICDS Clinical Trial

Public title

Exploration of Optimal Thyroid Resection Range in Papillary Thyroid Carcinoma with Lateral Neck Lymph Node Metastasis

Acronym

OPL trial

Scientific Title

Exploration of Optimal Thyroid Resection Range in Papillary Thyroid Carcinoma with Lateral Neck Lymph Node Metastasis

Scientific Title:Acronym

OPL trial

Region

Japan

Condition

intermediate-risk cN1b papillary thyroid carcinoma (PTC) with both primary tumors and lymph node metastases in the ipsilateral neck region

Classification by specialty

Endocrine surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare survival and recurrence outcomes between patients who underwent a lobectomy + ipsilateral lymph node dissection (LND) and those who underwent a total thyroidectomy + ipsilateral LND for intermediate-risk cN1b PTC with both primary tumors and lymph node metastases in the ipsilateral neck region.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival (OS)

Key secondary outcomes

Recurrence-free survival (RFS), Modified RFS, Any determinants of being assigned a lobectomy versus a total thyroidectomy.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent surgery for intermediate-risk cN1b PTC with both primary tumors and lymph node metastases in the ipsilateral neck region between 2005 and 2012 at Ito Hospital.

Key exclusion criteria

Patients with PTC exhibiting high-risk factors, including (i) distant metastases, (ii) any metastatic lymph node 3 cm and over in largest dimension, (iii) T4, or (iv) incomplete tumor resection.
Patients with (v) final pathology indicating non-PTC or (vi) concurrent other thyroid cancers.

Target sample size

400

Name of lead principal investigator

1st name	Yoshiyuki
Middle name
Last name	Saito

Organization

Ito hospital

Division name

Department of Surgery

Zip code

160-8582

Address

4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan

TEL

+81-3-3402-741

Email

y-saito@ito-hospital.jp

Name of contact person

1st name	Yoshiyuki
Middle name
Last name	Saito

Organization

Ito hospital

Division name

Department of Surgery

Zip code

160-8582

Address

4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan

TEL

+81-3-3402-7411

Homepage URL

Email

y-saito@ito-hospital.jp

Institute

Ito hospital

Institute

Department

Personal name

Saito, Yoshiyuki

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ito Hospital Institutional Review Board

Address

4-3-6 Jinguumae, Shibuya-ku, Tokyo, Japan

Tel

+81-3-3402-7411

Email

k-sugino@ito-hospital.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

伊藤病院（東京都）

Date of disclosure of the study information

2024

Year

01

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

401

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

11

Month

21

Day

Date of IRB

2023

Year

11

Month

27

Day

Anticipated trial start date

2023

Year

12

Month

01

Day

Last follow-up date

2024

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Objective: To compare survival and recurrence outcomes between patients who underwent a lobectomy + ipsilateral lymph node dissection (LND) and those who underwent a total thyroidectomy + ipsilateral LND for intermediate-risk cN1b PTC with both primary tumors and lymph node metastases in the ipsilateral neck region.
Design: Retrospective cohort study.
Setting: Ito Hospital, Tokyo, Japan.
Participants: Patients who underwent surgery for PTC between January 2005 and December 2012, excluding high-risk PTCs and concurrent other thyroid cancers.
Main Outcome and Measure: We performed an inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier analysis and a Cox proportional hazards regression analysis to compare the patients' overall survival (OS), recurrence-free survival (RFS), and modified RFS (which considered the potential need for a future contralateral lobectomy).

Registered date

2024

Year

01

Month

27

Day

Last modified on

2024

Year

01

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061016