Comparing laparoscopic and open surgery for lower mediastinal lymph node dissection in esophagogastric junction cancer
Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Siewert Type II/III Adenocarcinoma of Esophagogastric Junction: an Exploratory, Prospective, Observational, IDEAL Stage 2, Cohort Study
This study is testing whether laparoscopic surgery is better than open surgery for removing lymph nodes in patients with cancer at the esophagogastric junction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1036 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04443478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare laparoscopic versus open lower mediastinal lymphadenectomy in patients with adenocarcinoma of the esophagogastric junction. It will provide standard technical details for laparoscopic procedures and explore potential clinical effects, while also gathering essential data for future studies on sample size and outcomes. The study involves a multi-center, prospective cohort design, where patients will undergo radical gastrectomy with lymphadenectomy using either surgical approach as determined by the investigator. The focus is on optimizing surgical methods within the IDEAL framework for evidence-based practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with confirmed adenocarcinoma of the esophagogastric junction who are eligible for radical gastrectomy.
Not a fit: Patients with advanced disease stages or those who have received preoperative anti-neoplastic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical techniques and improve outcomes for patients with esophagogastric junction cancer.
How similar studies have performed: While laparoscopic approaches have been explored in various surgical contexts, this specific comparison in lower mediastinal lymphadenectomy for esophagogastric junction cancer is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.