Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer

Summary

Mediastinal lymph node dissection has been adopted as standard treatment for adenocarcinoma of esophagogastric junction(AEJ). This multi-center, exploratory, prospective, cohort study aims at provide standard technical details of laparoscopic mediastinal lymph node dissection, and explore the potential clinical effects, gather key information for following study regarding sample size calculation, primary outcome and feasibility.

Eligibility

Inclusion Criteria:

* 18-80 years old;
* Karnofsky score ≥70%;Or ECOG score ≤2;
* Preoperative pathological biopsy confirmed adenocarcinoma.
* According to gastroscopy, abdominal CT or upper gastrointestinal angiography, the tumor site conforms to the definition of esophageal and gastric junction adenocarcinoma in the "Chinese expert consensus", that is, the tumor center is within 5cm above and below the esophagogastric anatomical junction and crosses or touches the esophagogastric junction;
* Length of esophageal invasion ≤2cm;
* By abdominal contrast-enhanced CT/MRI, the clinical stage was CT2-4aN0-3M0 (according to AJCC-8th TNM tumor stage);
* Subject's blood routine and biochemical indicators meet the following standards: hemoglobin ≥80g/L; Absolute count of neutrophils (ANC) ≥1.5×109/L; Platelet ≥75×109/L;ALT and AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin ≤1.5 times the normal upper limit; Serum creatinine ≤ the normal upper limit; Serum albumin ≥30g/L;
* Obtain written informed consent.

Exclusion Criteria:

* Any anti-cancerous treatment received prior to surgery.
* Multiple malignant lesions in the stomach.
* Suspicious lymph node metastasis in the middle and/or upper mediastinum.
* Surgical history in the upper abdomen (laparoscopic cholecystectomy excluded).
* Pregnant or breastfeeding women.
* Uncontrolled epilepsy, central nervous system disease or mental disorder.
* The Bulky N2 status.
* The emergency surgery.
* Severe heart disease.
* History of cerebral infarction or cerebral hemorrhage within 6 months.
* Organ transplant recipients who need immunosuppressive therapies.
* Other malignancy diagnosed within 5 years (cured dermoid caner and cervical cancer excluded).

Conditions2

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