A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique (NCT06300879) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
China30 participantsStarted 2024-01-01
Plain-language summary
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).
The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
Who can participate
Age range
18 Years – 75 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
. Age between 18 and 75 years old;
. Pathologically confirmed as adenocarcinoma;
. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
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
Assess intraoperative Perioperative Safety by Duration of surgery.
Timeframe: intraoperative
2
Assess intraoperative Perioperative Safety by Duration of anastomosis.
Timeframe: intraoperative
3
Assess intraoperative Perioperative Safety by blood loss .
Timeframe: intraoperative
4
Postoperative recovery course
Timeframe: 30 days after the surgery
5
Postoperative TNM staging by Pathological findings .