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Not yet recruitingNCT03813173Updated Jul 5, 2019

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

An interventional study of lymph node dissection in Lymph Node Metastases, sponsored by Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6,000
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

This study is divided into three stages. In the first stage, the investigators try to explore the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate the "clinical imaging standard of cN0PTC", and randomly enroll 2000 patients under the premise of meeting the standard to establish the "predictive model of cN0-pN+PTC".

In the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of "cN0-pN+PTC prediction model".

In the third stage, 2 000 patients without lymph node metastasis assessed by "cNo-pN+ PTC prediction model" will be randomly divided into experimental group and control group. The experimental group will be treated with pCND, while the experimental group will be treated without pCND. The central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. The two groups will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further evaluate the "cN0-pN+PTC prediction model" scientifically.

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Conditions studied

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In context

Lymphatic Metastasis

244 studies on the registry are indexed under Lymphatic Metastasis; 91 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 90 across 127 interventional studies indexed under Lymphatic Metastasis.

Browse Lymphatic Metastasis studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Phase I and II:

    1. aged 18 to 80 years old;
    2. the primary treatment of patients with unilateral or bilateral PTC;
    3. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
    4. ultrasonography of cervical VI lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no local or global echo enhancement;
    5. CT scan of cervical VI lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution;
    6. patients will voluntarily enter the study after informed consent;

Phase III:

  1. aged from 18 to 80 years old;
  2. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
  3. Unilateral or bilateral PTC without lymph node metastasis assessed by "cNo-pN+ PTC prediction model";
  4. patients will voluntarily enter the study after informed consent.

Exclusion criteria

Exclusion Criteria:

  • (1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6,000 participants (estimated)

Study arms

  • Active comparator
    central cervical dissection

    Procedure: lymph node dissection

  • Experimental
    non central cervical dissection

    Procedure: lymph node dissection

Interventions

  • Procedurelymph node dissection

    The patient was operated under general anesthesia with cervical hyper extension. The affected side or bilateral glandular lobes were resected routinely, which was confirmed as PTC by frozen section. Then one or both central lymph node dissection were separately packed and sent for examination. Scope of lymph node dissection in central carotid region: hyoid bone at the upper border, anonymous artery at the lower border, bilateral common carotid artery at the inner edge, shallow from the superficial layer of deep cervical fascia, deep to the deep layer of deep cervical fascia (anterior fascia). The right recurrent laryngeal nerve (RLN) passes through the central area of the right neck and should be specially protected.

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What researchers measure

Primary outcomes

  1. Recurrence of thyroid cancer

    Time frame: Participants will be followed from the operation to 20 year (maximum)

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03813173
Lead sponsor
Zhejiang University
Responsible party
Luo Dingcun (vice president of hospital, Zhejiang University) — Principal investigator
First posted
Jan 23, 2019
Start date
Jan 2020 (estimated)
Primary completion
Dec 2040 (estimated)
Completion
Dec 2040 (estimated)
Last update
Jul 5, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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