Clinical trial · Interventional
Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery for Submucosal Tumor at the Gastroesophageal Junction
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor (GIST) | Gastrointestinal Stromal Tumor | CURATED_BROADER | 0.80 |
| Submucosal Tumor of Gastrointestinal Tract | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic and endoscopic cooperative surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAVE-GEJ
- description
- 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
- interventionNames
- Procedure: laparoscopic and endoscopic cooperative surgery
Primary outcomes (8)
- measure
- Conversion to open surgery rate
- timeFrame
- During surgery
- description
- 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.
- measure
- Total operation time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 situations that make the participant unsuitable for participating in this study (such as mental disorders, poor adherence, etc.)
References
Publications (0)
Data not yet available