search
Back to results

Intra-operative Rapid Identification of Lymph Node and Parathyroid

Primary Purpose

Thyroid Cancer, Parathyroid; Absent, Hypocalcemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative identification method
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Cancer focused on measuring Parathyroid glands, Needle puncture, Diff-quik staining, PTH test assay, Thyroid cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Xijing hospitalRecruiting
  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

hypocalcemia
Rate of hypocalcemia after surgery

Secondary Outcome Measures

Accuracy,sensitivity and specificity
Accuracy,sensitivity and specificity of intraoperative identification method
Life quality
The EORTC QLQ-C30 questionnaire was used to assess the life quality of participances. We calculate the score from 5 functional aspects according to the questionnnaire.
operation time
Record the identification time of this novel method and the whole operation time

Full Information

First Posted
August 28, 2017
Last Updated
August 29, 2017
Sponsor
Xijing Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03268785
Brief Title
Intra-operative Rapid Identification of Lymph Node and Parathyroid
Official Title
Intra-operative Rapid Identification of Lymph Node and Parathyroid by Fine Needle Puncture for Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In the experiment group, when suspicious parathyroid glands or lymph nodes were observed, a 22 G needle was applied for in situ puncture at a 45 degree angle. The needle was initially thrust into the gland for 0.2 mm, and then we advanced the needle for another 0.2mm while gently withdrawing the plunger of the syringe and maintaining negative pressure. At this point, there has parathyroid tissue been adsorbed in the needle. Repeat this process in two different directions to guarantee the simple volume. When cell smears finished, the smears were fixed in stationary liquid within 2-4 seconds for 5-20 seconds, and then Diff-Quik (DQ) staining technique was proceeded for rapid identification using Diff-Quik staining kit according to the instruction. After the following Diff-quick staining for 30 seconds, we can make out parathyroid cells and lymph nodes under high power microscope. In addition,PTH immunochromatographic assay kit can also be used for parathyroid glands detection. Using indicator paper to dip to the punctured tissue, the existance of parathyroid glands could be ensured. HE (Hematoxylin and Eosin) staining was used for pathological verification of suspicious nodes found during surgery. The suspicious nodes occurred in surgery were isolated and fixed with 4% paraformaldehyde for 12 h, embedded in paraffin and cut into 3-µm serial sections. Corresponding sections were stained with hematoxylin (BASO Diagnostics Inc. Zhuhai) for 10 min at room temperature. Then, sections were washed with running water. Subsequently, sections were washed with Scott promote blue liquid for 1 min, 1% hydrochloric acid alcohol differentiation liquid for 20 s, and Scott promote blue liquid for 1 min. Then, sections were stained with eosin (BASO Diagnostics Inc. Zhuhai) for 30 s. Sections were washed with running water and sealed for observation. Finally, sections were observed by Image-Pro Plus 5.0 software (Media Cybernetics, Inc., Bethesda, MD, USA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Parathyroid; Absent, Hypocalcemia, Hypoparathyroidism Postprocedural
Keywords
Parathyroid glands, Needle puncture, Diff-quik staining, PTH test assay, Thyroid cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intraoperative identification method
Intervention Description
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.
Primary Outcome Measure Information:
Title
hypocalcemia
Description
Rate of hypocalcemia after surgery
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Accuracy,sensitivity and specificity
Description
Accuracy,sensitivity and specificity of intraoperative identification method
Time Frame
10 day after operation
Title
Life quality
Description
The EORTC QLQ-C30 questionnaire was used to assess the life quality of participances. We calculate the score from 5 functional aspects according to the questionnnaire.
Time Frame
3 months after surgery
Title
operation time
Description
Record the identification time of this novel method and the whole operation time
Time Frame
During the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Thyroid cancer patients undergoing thyroid cancer surgery Preoperative examination were all ready for surgery Diagnosed with thyroid cancer by fine needle puncture before surgery Exclusion Criteria: - Patients enrolled into another clinical study Pregnant patients Patients diagnosed with another life-treating disease Patients with surgical contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Ling, Prof.
Phone
029-84775271
Email
lingrui0105@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meiling Huang, MD
Phone
029-84775271
Email
huangmeiling@126.com
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Ling
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliang Zhang, Doctor
Phone
+862984775271
Email
zhangjl@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Juliang Zhang, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19012855
Citation
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.
Results Reference
background
PubMed Identifier
24144426
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=An+intact+parathyroid+hormone-based+protocol+for+the+prevention+and+treatment+of+symptomatic+hypocalcemia+after+thyroidectomy
Description
An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Preserving+function+and+quality+of+life+after+thyroid+and+parathyroid+surgery
Description
Preserving function and quality of life after thyroid and parathyroid surgery.

Learn more about this trial

Intra-operative Rapid Identification of Lymph Node and Parathyroid

We'll reach out to this number within 24 hrs