A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrecto… (NCT04423354) | Clinical Trial Compass
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A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG
China94 participantsStarted 2019-03-25
Plain-language summary
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction.
Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.
Primary study endpoints: The incidences of early postoperative complications and mortality.
The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.
Who can participate
Age range
18 Years – 78 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:
* Informed consent of patients;
* The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
* The endoscopic biopsy was diagnosed with adenocarcinoma;
* Preoperative clinical staging was cT1-4aNanyM0
* No distant metastasis and invasion of surrounding organs were found;
* ECOG score ranged from 0 to 1;
* ASA score ranged from I to III.
Exclusion Criteria:
* Pregnant or lactating women
* Have a severe mental illness
* History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
* History of other malignant tumors within 5 years
* History of unstable angina pectoris or myocardial infarction within 6 months
* FEV1% of pulmonary function test was less than 50% of expected value
* History of cerebral infarction or cerebral hemorrhage within 6 months
* Have severe liver and kidney damage
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 incidences of early perioperative complications
Timeframe: Within 30 days after surgery
2
Perioperative mortality
Timeframe: Within 30 days after surgery
Trial details
NCT IDNCT04423354
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine