The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma (pCND)

July 10, 2020 updated by: Ahmed Kamel Ali, Assiut University
The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asyut
      • Asyūţ, Asyut, Egypt
        • Recruiting
        • Ahmed Kamel
        • Contact:
          • ahmed kamel ali
          • Phone Number: 00201021259455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with papillary thyroid carcinoma with clinically negative lymph node who undergo total thyroidectomy and central neck dissetion in assiut university hospital, department of general surgery.

Description

Inclusion Criteria:

  • patients with papillary thyroid cancer with clinically node negative.

Exclusion Criteria:

  • patients with clinical evidence of nodal metastases.
  • patients with a previous history of thyroidectomy.
  • patients with mixed-type papillary thyroid cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with node negative papillary thyroid carcinoma
Procedure: central neck dissection
dissection of central cervical lymph node grope in low grade papillary thyroid cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection
Time Frame: 12 months
numbers of positive histopathological lymph node biopsies postoperative
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (ACTUAL)

September 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahmed1712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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