NCT03268785

Brief Summary

During surgery, a fine needle puncture was proceeded when suspicious nodes was found by clinician. Repeat the punction for 2-3 times from different orientation and then, Diff-quik staining or PTH immunochromatographic assay were proceeded for lymph node or parathyroid glands identification. Post-operative pathology outcome was considered as golden standard.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 28, 2017

Last Update Submit

August 29, 2017

Conditions

Thyroid CancerParathyroid; AbsentHypocalcemiaHypoparathyroidism Postprocedural

Keywords

Parathyroid glandsNeedle punctureDiff-quik stainingPTH test assayThyroid cancer

Outcome Measures

Primary Outcomes (1)

  • hypocalcemia

    Rate of hypocalcemia after surgery

    7 days after surgery

Secondary Outcomes (3)

  • Accuracy,sensitivity and specificity

    10 day after operation

  • Life quality

    3 months after surgery

  • operation time

    During the operation

Study Arms (2)

Control

NO INTERVENTION

Previous admitted patients who were given conventional thyroidectomy combined with central neck lymph node dissection, without intra-operative nodes identification were enrolled into control group.

Experimental group

EXPERIMENTAL

Newly admitted patients,from august 2016 to august 2018, who were given thyroidectomy combined with central neck lymph node dissection, with intra-operative identification of suspicious lymph nodes or parathyroid glands were regarded as experimental group.Intraoperative identification method includes Diff-quik staining and PTH test assay. 200 participants were planed for enrollment.

Diagnostic Test: Intraoperative identification method

Interventions

Intraoperative identification methodDIAGNOSTIC_TEST

After needle pucture of suspicious nodes, Diff-quik staining was used to distinct lymph nodes and parathyroid glands. PTH test assay was used for parathyroid identification. Postoperative HE staining were applied as golden standard.

Experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Thyroid cancer patients undergoing thyroid cancer surgery Preoperative examination were all ready for surgery Diagnosed with thyroid cancer by fine needle puncture before surgery

You may not qualify if:

  • \- Patients enrolled into another clinical study Pregnant patients Patients diagnosed with another life-treating disease Patients with surgical contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Xijing Hospital

Xi’an, Shanxi, 710032, China

RECRUITING

Related Publications (2)

  • Adler JT, Sippel RS, Schaefer S, Chen H. Preserving function and quality of life after thyroid and parathyroid surgery. Lancet Oncol. 2008 Nov;9(11):1069-75. doi: 10.1016/S1470-2045(08)70276-6.

    PMID: 19012855BACKGROUND

  • Carter Y, Chen H, Sippel RS. An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy. J Surg Res. 2014 Jan;186(1):23-8. doi: 10.1016/j.jss.2013.09.026. Epub 2013 Oct 8.

    PMID: 24144426BACKGROUND

Related Links

MeSH Terms

Conditions

Thyroid NeoplasmsHypocalcemia

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Central Study Contacts

Rui Ling, Prof.

CONTACT

029-84775271lingrui0105@163.com

Meiling Huang, MD

CONTACT

029-84775271huangmeiling@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 31, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

August 31, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)