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Two-field Versus Three-field Lymphadenectomy in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement

Comparison of Lymph Node Dissection Results and Prognosis in Thoracic Esophageal Carcinoma Without Cervical Lymph Node Involvement: Two-field Versus Three-field Lymph Node Dissection

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02448953
Enrollment
786
Registered
2015-05-20
Start date
2015-01-31
Completion date
2019-12-31
Last updated
2015-05-20

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

Conditions

Esophageal Cancer

Keywords

Without cervical lymph node involvement

Brief summary

The purpose of this study is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma patients without cervical lymph node involvement by preoperative CT and/or ultrasound treated by two-field lymphadenectomy or three-field lymphadenectomy.Another purpose of this study is to clarify whether the lymph node along the right recurrent laryngeal nerve can be taken as the sentinel lymph node which is able to indicate neck lymph node metastasis and necessity for three-field lymphadenectomy.

Detailed description

Esophageal carcinoma is a prevalent and aggressive malignant disease with poor prognosis in China. Complete surgical resection with systemic lymph node dissection remains the most effective treatment method for this malignancy. Although tree-field lymph node dissection was reported to be effective in improving long-term survival in Japan,there is no enough evidences yet to demonstrate that three field lymph node dissection is superior to two field lymph node dissection in reducing postoperative recurrence and improving long-term survival. In this study, the dissection of lymph node adjacent to the right recurrent laryngeal nerve would be performed and examined routinely by intraoperative frozen-section. If the lymph node is positive, three field lymph node dissection(Cervical-thoracic-upper abdominal lymphadenectomy) will be performed, if negative, the patients will be randomly assigned either to three-field lymphadenectomy group or two-field lymphadenectomy group. The purpose of this large scale multi-center trial is to compare the lymph node dissection results and prognosis in thoracic esophageal carcinoma without cervical lymph node involvement treated by three-field lymphadenectomy or two-field lymphadenectomy and clarify whether the lymph node along the right recurrent laryngeal nerve could be taken as sentinel lymph node indicating neck lymph node metastasis and necessity of three-field lymphadenectomy.

Interventions

PROCEDURETwo-field lymphadenectomy

Thoracic-upper abdominal two-field lymphadenectomy

PROCEDUREThree-field lymphadenectomy

Cervical-thoracic-upper abdominal three-field completely lymphadenectomy

Sponsors

Peking University Cancer Hospital & Institute
CollaboratorOTHER
Henan Cancer Hospital
CollaboratorOTHER_GOV
Hebei Medical University Fourth Hospital
CollaboratorOTHER
Sichuan Cancer Hospital and Research Institute
CollaboratorOTHER
Fujian Cancer Hospital
CollaboratorOTHER_GOV
Liaoning Cancer Hospital & Institute
CollaboratorOTHER
Zhejiang Cancer Hospital
CollaboratorOTHER
Tongji Hospital
CollaboratorOTHER
Tang-Du Hospital
CollaboratorOTHER
Shanghai Chest Hospital
CollaboratorOTHER
Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with histologically confirmed squamous cell esophageal cancer, without any previous anti-tumor therapy; 2. Preoperative clinical TNM stage:cT1b-3N0-1M0; 3. Adequate cardiopulmonary, liver, brain and kidney functions for esophagectomy either via right thoracotomy or VATS; 4. No evidence of suspicious neck lymph node metastasis (LN short diameter \< 0.8cm or LN short/long diameter \<0.65 by cervical CT and/or ultrasound); 5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail

Exclusion criteria

1. Previous use of anti-cancer therapy; 2. Preoperative clinical TNM stage: N2-3 or M1; 3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery; 4. Previous malignancy history. 5. Suspicious neck lymph node metastasis (LN short diameter ≧0.8cm or LN short/long diameter ≧0.65 by cervical CT and/or ultrasound); 6. Unwilling to participate the clinical trial and refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Long term survival5 years

Secondary

MeasureTime frame
Disease free survival5 years
Locoregional recurrence5 years
Postoperative complications3 years

Countries

China

Contacts

Primary ContactYousheng Mao, MD
maoysherx@126.com8610-87787138
Backup ContactZhirong Zhang, MD
zhangzr@cicams.ac.cn8610-87788798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026