Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery for Submucosal Tumor at the Gastroesophageal Junction

Condition(s) studied

Investigational drug(s) / intervention(s)

laparoscopic and endoscopic cooperative surgery: The mesenteric preconditioning technique is employed in combination with Submucosal Tunneling Endoscopic Resection (STER), endoscopic submucosal dissection (ESD), or traditional laparoscopic and endoscopic cooperative surgery(LECS), supplemented by laparoscopic reinforcement suturing

Study 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.

Eligibility

Primary outcome measure(s)

• Conversion to open surgery rate — During surgery
  It is defined as the proportion of cases that are converted to open surgery due to operational difficulties during the procedure, preventing the continuation of laparoscopic and endoscopic cooperative surgery.
• Total operation time — During surgery
  The total duration (in minutes) from the commencement of laparoscopic incision to the completion of suturing all incisions
• Number of endoscopic hemostasis procedures — The day of surgery
  The number of times endoscopic hemostasis (including having to interrupt the surgery to use electrocoagulation and hemostatic clips alone for hemostasis) was required due to submucosal or wound bleeding during the operation
• Endoscopic hemostasis time — The day of surgery (in minutes),up to 1440minutes (24hours)
  Total duration (in minutes) for endoscopic hemostasis during the procedure
• Perioperative complication rate — Within 30 days after surgery
  Based on the Clavien-Dindo classification system, complications occurring within 30 days after surgery, including anastomotic leakage, postoperative bleeding, delayed gastric emptying, abdominal infection, and esophagogastric anastomotic stenosis, are recorded, and their severity is assessed
• Postoperative peripheral white blood cell count — On the first and third days after surgery.
  Blood tests for inflammation indicator, including peripheral white blood cell count, conducted on the first and third days after surgery.
• Adverse Events (AE) — within 30 days after surgery
  Record all adverse events that occur from the time of signing the informed consent form to within 30 days after surgery, grade them according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) of the National Cancer Institute, and assess their correlation with the patient's surgery.
• Serious Adverse Event (SAE) — within 30 days after surgery
  Any event that leads to death, endangers life, requires hospitalization or prolongs hospitalization, or results in permanent or severe disability or loss of function must be reported to the ethics committee and relevant hospital authorities within 24 hours of being notified.

Trial sites (1)

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