Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery… (NCT07550582) | Clinical Trial Compass
By InvitationPhase 2
Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery for Submucosal Tumor at the Gastroesophageal Junction
China40 participantsStarted 2026-04-01
Plain-language summary
This study is a single-center, prospective, single-arm, exploratory clinical study (phase II exploratory trial). No parallel control group was established in the study, and all subjects who met the inclusion criteria underwent a uniform surgical treatment approach, namely, double-scope combined resection with mesenteric vascular preconditioning. The study aims to preliminarily evaluate the safety and effectiveness of this novel surgical strategy for the treatment of submucosal tumor at the gastroesophageal junction, and to provide data support for subsequent larger-scale controlled studies.
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:
* Aged 18 to 80 (inclusive), of either gender.
* Preoperative gastroscopy, enhanced CT, and/or endoscopic ultrasonography (EUS) examinations led to a clinical diagnosis of submucosal tumor (SMT) at the gastroesophageal junction.
* The maximum diameter of SMT is 1\~5 cm (based on radiological measurements).
* The distance from the upper margin of the SMT to the dentate line of the esophagogastric junction is ≤2 cm.
* Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1.
* Plan to undergo laparoscopic surgery, and the researcher judges that the patient is suitable for the combined surgical procedure involved in this study.
* Volunteer to participate in this study and sign a written informed consent form.
Exclusion Criteria:
* SMT that meets the absolute indications for endoscopic treatment alone (such as lesions with a diameter of \<1cm that can be completely resected endoscopically).
* Patients with severe systemic diseases such as heart, lung, liver, and kidney dysfunction, who are unable to tolerate surgery or anesthesia after evaluation.
* Women who are pregnant or breastfeeding.
* Previous history of upper abdominal surgery.
* Previously received upper abdominal radiotherapy.
* Have suffered from or currently suffer from other malignant tumors within the past 5 years.
* Lesions accompanied by clear ulcers, metastasis, or lesions after neoadjuvant and conversion therapy.
* The researcher determines that there are any other situati…
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
Conversion to open surgery rate
Timeframe: During surgery
2
Total operation time
Timeframe: During surgery
3
Number of endoscopic hemostasis procedures
Timeframe: The day of surgery
4
Endoscopic hemostasis time
Timeframe: The day of surgery (in minutes),up to 1440minutes (24hours)
5
Perioperative complication rate
Timeframe: Within 30 days after surgery
6
Postoperative peripheral white blood cell count
Timeframe: On the first and third days after surgery.