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

NCT07550582 | Enrolling By Invitation Phase 2

• 1 other identifier: 2026-z076
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Stromal Tumor (GIST); Submucosal Tumor of Gastrointestinal Tract

Keywords

SMT; GIST; Gastrointestinal Submucous Lesion

Outcome Measures

Primary Outcomes (8)

• 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.

  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

Secondary Outcomes (9)

• 5-year disease-free survival (DFS)

  5 year after surgery

• 5-year overall survival (OS)

  5 year after surgery

• R0 resection rate

  During 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)

Study Arms (1)

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

Procedure: laparoscopic and endoscopic cooperative surgery

Interventions

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

SAVE-GEJ

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People' Hosptial

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy Center

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)