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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.
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.
Secondary outcomes: Evaluate the oncological efficacy of the surgical regimen, including 5-year disease-free survival (DFS) and overall survival (OS). Assess the impact of the surgical regimen on patients' postoperative gastric function and quality of life, through comprehensive evaluation using upper gastrointestinal imaging, gastric function scores (such as STO22), quality of life scales (EORTC QLQ-C30), and nutritional indicators. Explore the factors related to surgical success and patient prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAVE-GEJ | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic and endoscopic cooperative surgery | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to open surgery rate | 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. | During surgery |
| Total operation time | The total duration (in minutes) from the commencement of laparoscopic incision to the completion of suturing all incisions | During surgery |
| Number of endoscopic hemostasis procedures | 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 | The day of surgery |
| Endoscopic hemostasis time | Total duration (in minutes) for endoscopic hemostasis during the procedure | The day of surgery (in minutes),up to 1440minutes (24hours) |
| Perioperative complication rate | 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 | Within 30 days after surgery |
| Postoperative peripheral white blood cell count | Blood tests for inflammation indicator, including peripheral white blood cell count, conducted on the first and third days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year disease-free survival (DFS) | The time (in months) from the date of surgery to the first occurrence of tumor recurrence, metastasis, or death from any cause. If none of these events occurs, the duration is censored at the last follow-up date. | 5 year after surgery |
| 5-year overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People' Hosptial | Beijing | Beijing Municipality | 100044 | China |
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|
| On the first and third days after surgery. |
| Adverse Events (AE) | 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. | within 30 days after surgery |
| Serious Adverse Event (SAE) | 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. | within 30 days after surgery |
The time from the date of surgery to death from any cause (in months), or censored at the last follow-up date if death does not occur. |
| 5 year after surgery |
| R0 resection rate | The proportion of cases where postoperative pathological examination confirms negative tumor margins under the microscope and there is no intraoperative tumor rupture. | During surgery |
| Time to first liquid intake after surgery | The time interval (in days) from the end of surgery to the first intake of liquid food after surgery. | 30days after surgery |
| Postoperative hospitalization days | The time interval (in days) from the completion of surgery to the patient's discharge | From date of completion of surgery until the date of discharge，assessed up to 3 months(in days) |
| Total hospitalization cost (yuan) | The total amount of all expenses incurred by the inpatient (yuan) | 30day after surgery |
| Quality of life assessment（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30） | The European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) was used for assessment, which was conducted before surgery, and at 3 months, 1 year, 3 years, and 5 years after surgery.Score Range: 0 to 100 for all scales.Functional & Global Health Status Scales: Higher scores = Better Outcome. A high score indicates better functioning and overall quality of life.Symptom & Single-Item Scales: Higher scores = Worse Outcome. A high score indicates a higher level of symptoms or problems | 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 ） | Assessed using the gastric cancer-specific module (EORTC QLQ-STO22) before surgery, and at 3 months, 1 year, 3 years, and 5 years after surgery. Score Range: Like the QLQ-C30, each scale's raw scores are linearly transformed to a standardized range of 0 to 100 for analysis and comparison. Scoring Direction: The meaning of a "higher score" depends on the specific subscale. Symptom Scales and Single-Item Measures (e.g., Dysphagia, Pain, Reflux, Eating Restrictions): A higher score = worse outcome. A high score indicates a higher symptom burden or more severe problem. Functional Scales: A higher score = better outcome (e.g., better physical function). The STO22 module consists entirely of symptom-related scales and single items, and all are scored higher = worse outcome. | 5 years after surgery. |
| Number of participants with treatment-related adverse events assessed by upper gastrointestinal series | One year after surgery, an upper gastrointestinal series is performed to assess number of participants with treatment-related adverse events，including gastroesophageal reflux, delayed gastric emptying, or abnormal anastomotic morphology | 1 year after surgery |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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