PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)

Study Overview
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Brief Summary
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Esophageal cancer is the eighth most common cancer around the world, with more than 450000 new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is the mainstay of treatment in many countries for patients with esophageal cancer. To improve the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was started in 1980s. More potential positive lymph nodes were found during more extended lymphadenectomy, offering more accurate TNM staging, affecting consequent treatment. However，3-field-lymphadenectomy was associated with increased surgical morbidity and mortality. Positron emission tomography (PET) is used for detecting distant metastases and lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and to determine if investigators can use PET to guide future cervical lymphadenectomy. (Eastern Cooperative Thoracic Oncology Projects 2003, ECTOP-2003)

Detailed Description
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From June, 2018, a total of 110 patients with thoracic esophageal carcinoma will be recruited in 4 hospital in China. Participants with resectable esophageal cancer will have PET/CT scan before three-field lymphadenectomy. Lymph nodes will be recored according to the anatomy site. Lymph nodes metastasis diagnosed by PET/CT and by postoperation pathological examination will be compared to evaluate the role of PET/CT in guiding the extent of lymphadenecomy and surgical approach.

Official Title
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The Utility of Positron Emission Tomography (PET) in Predicting Cervical Lymphatic Metastasis for Mid-lower Thoracic Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Diagnostic Test: positron emission tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven esophageal cancer Resectable cT1-T3/N0-N1 thoracic，operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, and barium swallow Karnofsky performance status greater than or equal to 80% Acceptable pulmonary and cardiac function. Acceptable hepatic, renal and bone marrow function Exclusion Criteria: Low performance status(Karnofsky score <80%) Past history of malignancy Unresectable advanced disease(T4 or M1a,M1b) Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment Medically unfit for surgical resection Pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy. A significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment. Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis. Significant psychiatric illness that would interfere with patient compliance Severe hepatic cirrhosis or with serious renal disease unacceptable for surgery Salvage surgery after definitive chemoradiotherapy Patients have neoadjuvant chemoradiotherapy Above the age of 80 years Unreliable for follow up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: positron emission tomography|patients who had esophagectomy with 3-field lymphadenectomy underwent examination of positron emission tomography prior to surgery within 2 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical lymph node metastasis | postoperative pathological examination | Decembear 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mediastinal and abdonimal lymph nodes metastasis | postoperative pathological examination | Novermber 2018 | 
| postoperative complications | surgical morbidity and mortality | March 2019 | 
| diseases-free survival | from the time of surgery to the time of first recurrence or death | November 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positron emission tomography, cervical lymphatic metastasis