Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer (NCT04443478) | Clinical Trial Compass
RecruitingNot Applicable
Laparoscopic Versus Open Lower Mediastinal Lymphadenectomy for Esophagogastric Junction Cancer
China1,036 participantsStarted 2020-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 surge…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of lower mediastinal lymph nodes retrieved
Timeframe: immediately after the pathology report issued