Single-center Prospective Clinical Study on the Application of Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery for Submucosal Tumor at the Gastroesophageal Junction (SAVE-GEJ Trial)
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Conversion to open surgery rate
研究概览
简要总结
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.
详细描述
This study follows the PICO principle design, as detailed below:
Target population: Patients aged 18-80 years with gastroesophageal junction submucosal tumor, diagnosed by endoscopy, CT, and/or endoscopic ultrasonography, with a tumor diameter of 1-5cm and an upper margin ≤2cm from the esophageal dentate line, who plan to undergo surgical treatment.
Surgical approach: Pre-treatment of mesenteric vessels with combined resection using both endoscopes. Based on the distance between the upper edge of the tumor and the dentate line, the tumor is classified and the corresponding surgical procedure is adopted: Type I (involving the dentate line or lower esophagus): Pre-treatment of mesenteric vessels + Submucosal Endoscopic Tunneling Resection (STER) + laparoscopic reinforcement; Type II (≤1cm from the dentate line): Pre-treatment of mesenteric vessels + Endoscopic Submucosal Dissection (ESD) or STER surgery or Endoscopic Full-thickness Resection (EFTR) + laparoscopic reinforcement; Type III (1-2cm from the dentate line): Pre-treatment of mesenteric vessels + EFTR surgery + laparoscopic reinforcement. The distance between the tumor and the dentate line is measured endoscopically with the subject in a supine position under moderate insufflation during gastroscopy.
Clinical outcome:
Primary outcome: Evaluate the safety of this surgical protocol. The primary evaluation indicators are: conversion to open surgery rate, total operation time, number of endoscopic hemostasis attempts during the operation, hemostasis time, incidence of perioperative complications (such as bleeding, anastomotic leakage, gastroparesis, etc.), and changes in postoperative inflammatory markers in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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 situations that make the participant unsuitable for participating in this study (such as mental disorders, poor adherence, etc.)
研究组 & 干预措施
SAVE-GEJ
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
干预措施: laparoscopic and endoscopic cooperative surgery (Procedure)
结局指标
主要结局
Conversion to open surgery rate
时间窗: The day of 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
时间窗: The day of surgery
The total duration (in minutes) from the commencement of laparoscopic incision to the completion of suturing all incisions
Number of endoscopic hemostasis procedures
时间窗: 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
时间窗: The day of surgery (in minutes),up to 1440minutes (24hours)
Total duration (in minutes) for endoscopic hemostasis during the procedure
Perioperative complication rate
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
Conversion to open surgery rate
时间窗: 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
时间窗: During surgery
The total duration (in minutes) from the commencement of laparoscopic incision to the completion of suturing all incisions
次要结局
- 5-year disease-free survival (DFS)(5 year after surgery)
- 5-year overall survival (OS)(5 year after surgery)
- R0 resection rate(the day of surgery)
- Time to first liquid intake after surgery(30days after surgery)
- Postoperative hospitalization days(From date of completion of surgery until the date of discharge，assessed up to 3 months(in days))
- Total hospitalization cost (yuan)(30day after surgery)
- Quality of life assessment(5 years after surgery)
- Gastric function-specific score(5 years after surgery.)
- Number of participants with treatment-related adverse events assessed by upper gastrointestinal series(1 year after surgery)
- R0 resection rate(During surgery)
- Quality of life assessment（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30）(5 years after surgery)
- Gastric function-specific score（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach Cancer 22-item module ）(5 years after surgery.)
研究者
Zhang Liming
Director of Endoscopy Center
Peking University People's Hospital