The feasibility of Robot assisted mRND in advanced thyroid cancer patients; A pilot study
- Conditions
- Neoplasms
- Registration Number
- KCT0006867
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Patients aged 20 to 70
- patients who are planning to undergo total thyroidectomy and lateral lymph node dissection at Samsung Medical Center after confirming cervical lymph node metastasis with washing thyroglobulin level performed by imaging and fine needle aspiration tests.
- Patients with neck levels 2,3,4,5,6 lymph nodes metastasis and no direct invasion into nearby structures (carotid artery, jugular vein, pleural papillary muscle, airway, esophagus, nerves) and no severe adhesion suspected.
- Patients with thyroid cancer under 4cm.
- Patients whose metastatic lymph nodes are less than 3cm in size.
- Patients whose underlying disease does not affect general anesthesia time.
- The patient who agreed to this study and signed the consent form.
- patients whose the diameter of thyroid cancer exceeds 4cm,
- metastatic lymph node size is larger than general cervical metastasis lymph nodes (>3 cm)
- Patients with metastasis to bilateral cervical lymph nodes or bilateral cervical lymph node metastasis were excluded from the initial stage of this study, but if it is deemed safe according to the research progress, it can be changed to the subject.
- If metastatic lymph nodes are located below the clavicle or above the digastic muscle and exceed the range of neck levels 2,3,4,5,6, where metastatic lymph nodes are widely located and the number of metastatic lymph nodes is expected to be too large.
- When invasion of major organs such as nerves, airways, and esophagus is suspected in imaging tests (suspicious stage T4).
- If direct invasion of carotid artery, jugular vein, or pleural papillary muscle (SCM) is suspected in imaging examination,
- When traditional cervical lymph node resection is considered appropriate due to distant metastasis such as lung, liver, bone, skin, brain, and abdominal cavity (spicuous stage M1).
- In the case where the anesthesia time needs to be shortened as much as possible due to the existing comorbid disease,
- Major heart disease: acute myocardial infarction within 6 months, uncontrolled angina, and heart failure.
- Major lung disease: Patients with an effortless exhalation of less than 60% of normal people for 1 second.
- Kidney dysfunction: Patients with plasma creatinine above 2.0
- Liver dysfunction. - Patients with plasma total bilirubin of 2.0 or higher.
- Past history of cervical radiation therapy.
- The history of taking aspirin (or antiplatelet drugs) within 7 days before hospitalization.
- patients who take blood coagulation inhibitors
- Patients who are suspected of thyroiditis such as severe graves disease and Hashimoto thyroiditis and appropriate for incision.
- Significant psychiatric diseases (e.g., major depression) or history of taking antipsychotic drugs.
- If patients don't agree with the consent form,
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the average number of lymph nodes resected by robotic surgery
- Secondary Outcome Measures
Name Time Method whether Postoperative lesion completely removed or not, postoperative complications, postoperative pain, postoperative satisfaction, postoperative sensory abnormalities.