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A randomized controlled clinical trial of prophylactic central lymph node dissection and thyroidectomy in patients with advanced hypopharyngeal cancer

A randomized controlled clinical trial of prophylactic central lymph node dissection and thyroidectomy in patients with advanced hypopharyngeal cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064024
Enrollment
Unknown
Registered
2022-09-24
Start date
2022-09-24
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach cancer

Interventions

Hypopharyngeal tumor resection group:Routine hypopharyngeal carcinoma resection (or simultaneous partial/total laryngectomy) plus lateral lymph node dissection was performed
Central region lymph node dissection group:Central lymphadenectomy was performed on the basis of conventional hypopharyngeal carcinoma resection (or simultaneous partial/total laryngectomy) and latera
Thyroidectomy group:On the basis of conventional hypopharyngeal carcinoma resection (or simultaneous partial/total laryngectomy) + lateral lymph node dissection, central lymph node dissection + ipsila

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with hypopharyngeal cancer according to preoperative imaging data and other data, and with AJCC 8th stage T3 or T4 2. Age 18 or older 3. Informed consent can be signed 4. Never received surgical treatment, radiotherapy, chemotherapy or immunotherapy for hypopharyngeal cancer

Exclusion criteria

Exclusion criteria: 1. Patients with previous or concurrent cancers 2. Preoperative CT, MRI and/or color ultrasound imaging indicated thyroid and/or central lymph node invasion (specific criteria are shown below) 3. Patients with distant metastasis 4. Patients with general general condition (especially cardiopulmonary function) not sufficient to tolerate surgery, thyroid disease and/or parathyroid disease 5. Mental disorders and other diseases that cannot be coordinated with medication or examination 6. Women who are breastfeeding, pregnant or likely to become pregnant 7. Unable or unwilling to cooperate to complete the follow-up The involvement of central lymph nodes is radiographically determined and is consistent with structural and/or functional imaging assessment Another thought was that the patient had a central lymph node involvement. Whether the patient has a central lymph node and/or thyroid gland Invasion by the west China Hospital of Sichuan University otorhinolaryngology head and neck surgeons and west China Hospital of Sichuan University imaging physicians In case of any dispute, another doctor from the Department of Radiology, West China Hospital of Sichuan University will arbitrate the case. 8. Structural imaging evaluation criteria: 1) lymph nodes larger than 6-8mm in retropharyngeal or parapharyngeal area, 2) lymph nodes larger than 15mm in i-ii area, or larger than 10mm in iii-vi area, 3) necrosis; Cystic degeneration, invasion (indistinct boundary), 4) globose (not flattened or beanshaped), appearing in clusters (even without lymph nodes of the above diameter line size) 9. Functional imaging evaluation criteria: 1) Limited diffusion in DWI (high B value 1000); 2) ADC value (b600,800,1000) <0.965x10-3 mm2/s, (diameter line 2mm, value twice, take its average value).

Design outcomes

Primary

MeasureTime frame
Overall survival time;Recurrence free survival time;The recurrence rate;Postoperative swallowing function;Voice function;The quality of life;Symptoms of hypothyroidism;

Countries

China

Contacts

Public ContactRen Jianjun

West China Hospital, Sichuan University

jianjun.ren@scu.edu.cn18682753865

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026