Submucosal Tumor of Gastrointestinal TractPhase 2SAVE-GEJNCT07550582
Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery for Submucosal Tumor at the Gastroesophageal Junction
A Phase 2 study testing laparoscopic and endoscopic cooperative surgery in people with Submucosal Tumor of Gastrointestinal Tract and Gastrointestinal Stromal Tumor (GIST), run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Submucosal Tumor of Gastrointestinal Tract, Gastrointestinal Stromal Tumor (GIST)
- What is being tested?
- laparoscopic and endoscopic cooperative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People' Hosptial
Beijing, Beijing Municipality, 100044
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- laparoscopic and endoscopic cooperative surgery
- Keywords
- SMT, GIST, Gastrointestinal Submucous Lesion
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic and endoscopic cooperative surgeryProcedure or 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: laparoscopic and endoscopic cooperative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Total operation time
The total duration (in minutes) from the commencement of laparoscopic incision to the completion of suturing all incisions
Measured: 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
Measured: The day of surgery
Endoscopic hemostasis time
Total duration (in minutes) for endoscopic hemostasis during the procedure
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 30 days after surgery
Secondary outcomes (9)
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.
Measured: 5 year after surgery
5-year overall survival (OS)
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.
Measured: 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.
Measured: 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.
Measured: 30days after surgery
Postoperative hospitalization days
The time interval (in days) from the completion of surgery to the patient's discharge
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Apr 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submucosal Tumor of Gastrointestinal TractStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Liming, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550582
- Sponsor's protocol ID
- 2026-z076
- Acronym
- SAVE-GEJ
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07550582
- Acronym / sponsor ID
- SAVE-GEJ / 2026-z076
- Keywords
- SMT, GIST, Gastrointestinal Submucous Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2031 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAVE-GEJ | Experimental | Procedure: laparoscopic and endoscopic cooperative surgeryThe 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic and endoscopic cooperative surgeryThe 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 or surgery | SAVE-GEJ |
Primary outcome
Conversion to open surgery rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The day of surgery (in minutes),up to 1440minutes (24hours)
Total duration (in minutes) for endoscopic hemostasis during the procedure
Perioperative complication rate
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
9 secondary outcomes
5-year disease-free survival (DFS)
Time frame: 5 year after surgery
5-year overall survival (OS)
Time frame: 5 year after surgery
R0 resection rate
Time frame: During surgery
Time to first liquid intake after surgery
Time frame: 30days after surgery
Postoperative hospitalization days
Time frame: From date of completion of surgery until the date of discharge，assessed up to 3 months(in days)
Total hospitalization cost (yuan)
Time frame: 30day after surgery
Quality of life assessment（European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30）
Time frame: 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 ）
Time frame: 5 years after surgery.
Number of participants with treatment-related adverse events assessed by upper gastrointestinal series
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laparoscopic and endoscopic cooperative surgery in people with Submucosal Tumor of Gastrointestinal Tract and Gastrointestinal Stromal Tumor (GIST), run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to open surgery rate (time frame: During surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.