Intra-operative Rapid Identification of Lymph Node and Parathyroid

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268785
• Other study ID #: KY20162049-X-1
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2017
• Last updated: August 29, 2017
• Start date: August 1, 2016
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2017
• Source: Xijing Hospital
• Contact: Rui Ling, Prof.
• Phone: 029-84775271
• Email: lingrui0105[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia
• Hypoparathyroidism
• Hypoparathyroidism Postprocedural
• Parathyroid; Absent
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypocalcemia	Rate of hypocalcemia after surgery	7 days after surgery
Secondary	Accuracy,sensitivity and specificity	Accuracy,sensitivity and specificity of intraoperative identification method	10 day after operation
Secondary	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
Secondary	operation time	Record the identification time of this novel method and the whole operation time	During the operation

External 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.