Intra-operative Rapid Identification of Lymph Node and Parathyroid

Intra-operative Rapid Identification of Lymph Node and Parathyroid by Fine Needle Puncture for Thyroid Carcinoma

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.

Study Overview

• Status: Unknown
• Conditions: Hypocalcemia; Thyroid Cancer; Hypoparathyroidism Postprocedural; Parathyroid; Absent
• Intervention / Treatment: Diagnostic test: Intraoperative identification method

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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: Experimental 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.	Diagnostic test: Intraoperative identification method; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypocalcemia	Rate of hypocalcemia after surgery	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy,sensitivity and specificity	Accuracy,sensitivity and specificity of intraoperative identification method	10 day after operation
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.	3 months after surgery
operation time	Record the identification time of this novel method and the whole operation time	During the operation

Collaborators and Investigators

• Sponsor: Xijing Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy
• Preserving function and quality of life after thyroid and parathyroid surgery.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Thyroid cancer; Parathyroid glands; Needle puncture; Diff-quik staining; PTH test assay
• Additional Relevant MeSH Terms: Metabolic Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases; Head and Neck Neoplasms; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Thyroid Diseases; Thyroid Neoplasms; Hypoparathyroidism; Hypocalcemia
• Other Study ID Numbers: KY20162049-X-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No