Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for AGC
China170 participantsStarted 2018-07-01
Plain-language summary
The purpose of this study is to explore the safety and feasibility of laparoscopic spleen-preserving No. 10 lymph node dissection for patients with advanced middle or upper third gastric cancer.
Who can participate
Age range
18 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:
* Patients age older than 18 years (including 18 years old);
* The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
* Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
* Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
* The Eastern Cooperative Oncology Group performance status of 0 or 1;
* The American Society of Anesthesiology classes of I, II or III;
* Signed Informed consent.
Exclusion Criteria:
* Pregnant or lactating women;
* Suffering from severe mental disorder;
* Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
* Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
* Siewert I type adenocarcinoma of the esophagogastric junction;
* Other malignant diseases (within 5 years);
* Other illnesses needed operation concurrently;
* Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
* Pulmonary function tests FEV1 less than 50% of predicted value;
* Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep …
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 incidence of postoperative complications within 30 days
Timeframe: 30 days
Trial details
NCT IDNCT03708783
SponsorPeking University Cancer Hospital & Institute