NCT03813706Not yet recruiting
the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma
Prospective Study for the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma
Source: ClinicalTrials.gov · Last updated 5 Jul 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study was completed in two stages. In the first stage, 2000 participants were enrolled according to the criteria. Following the principle of informed consent and voluntary consent of patients, the standard operation was "right or bilateral thyroidectomy + isthmus resection + right area VI lymph node dissection + left area VI lymph node dissection + lateral neck lymph node dissection". The age of participants, the size of right thyroid tumors, the invasion of the capsule and the number of lateral neck lymph node metastasis were counted to validate and improve the predictive model of lymph node posterior to the right recurrent laryngeal nerve in papillary thyroid cancer (Y=-0.029×age+0.771×tumor size+0.660×capsular invasion+1.331×right lateral lymph node metastasis-1.687, Y ≥0.16 means right recurrent laryngeal nerve posterior lymph node metastasis). In the second stage, 2000 participants assessed by the model without posterior right recurrent laryngeal nerve metastasis were randomly divided into experimental group and control group according to the principle of informed consent and voluntary. The right recurrent laryngeal nerve posterior lymph nodes were not dissected in experimental group, while the right recurrent laryngeal nerve posterior lymph nodes were routinely dissected in control group. Through long-term follow-up and comparison of RFS and OS between the two groups, the investigators can scientifically evaluate the effectiveness of the "prediction model of lymph node posterior to right recurrent laryngeal nerve metastasis in papillary thyroid carcinoma", and seek evidence for accurate treatment of lymph node posterior to the right recurrent laryngeal nerve in thyroid papillary carcinoma.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 4000 (estimated)
- First submitted
- 16 Jan 2019
- Start date
- Jan 2020
- Primary completion date
- Dec 2040
- Lead sponsor
- Zhejiang University
- Diseases
- Thyroid cancer
- NCT number
- NCT03813706
What you commit to
- Study type: Interventional
- Planned participants: 4000
- From Jan 2020 to the primary completion date, Dec 2040
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- other malignant tumor history;
- history of neck trauma.
Other
- patients refused to participate in the study;
- non first operation patients;
- distant metastasis;
Who the study is looking for
- Phase I:
- aged from 18 years old to 80 years old;
- the primary treatment of patients with right or bilateral PTC;
- patients will voluntarily enter the study after informed consent.
- Phase II:
- aged from 18 years old to 80 years old;
- the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the "prediction model of LN-prRLN";
- patients will voluntarily enter the study after informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.