Clinical trial NCT03268785: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Parathyroid; Absent
Hypocalcemia
Hypoparathyroidism Postprocedural
Keywords: Parathyroid glands
Needle puncture
Diff-quik staining
PTH test assay
Thyroid cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: hypocalcemia
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Accuracy,sensitivity and specificity
timeFrame: 10 day after operation
measure: Life quality
timeFrame: 3 months after surgery
measure: operation time
timeFrame: During the operation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
References:
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.
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.