Stomach NeoplasmsNCT07260461
The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.
A study testing Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) in people with Stomach Neoplasms and Adenocarcinoma - Gastroesophageal Junction (GEJ), run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach. The current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Stomach Neoplasms, Adenocarcinoma - Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer
- What is being tested?
- Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Sep 2028
- Phase
- Interventional
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged from 18 to 75 years old;
- Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;
- The tumor was located in the proximal third of the stomach.
- ECOG score of 0 or 1;
- D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).
- ASA grade I to III;
- The preoperative nutritional status of the patients was good without severe malnutrition.
- Voluntarily sign informed consent.
Who cannot join
- Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;
- Severe respiratory diseases: severe impairment of lung function (FEV1%<50%) or chronic respiratory failure;
- Severe liver and kidney dysfunction: ALT/AST > 3 times the upper limit of normal, or eGFR < 30 mL/min/1.73m²;
- patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;
- Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.
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- Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;
- Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;
- Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);
- Pregnant or lactating women;
- Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;
- Severe malnutrition before surgery: BMI < 16 kg/m² or albumin < 25 g/L;
- Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.
This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach.
The current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux.
Read more
The main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes.
The study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.
- Conditions
- Stomach Neoplasms, Adenocarcinoma - Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer
- Being tested
- Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)Procedure or surgery
Experimental group (tbROSF group): Participants will undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using tubulized-stomach right-open single-flap valvuloplasty (tbROSF).
Control group (LTG group): Participants will undergo laparoscopic total gastrectomy (LTG), with digestive tract reconstruction performed using a standard Roux-en-Y anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| LTG-tbROSF | Experimental | The subjects undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using the right-sided overlap and single-flap valvuloplasty (ROSF) on the tubular stomach. Receives: Procedure: Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) |
| LTG | Active comparator | Patients in the control group will undergo Laparoscopic Total Gastrectomy (LTG), and digestive tract reconstruction will be performed using a standard Roux-en-Y anastomosis. Receives: Procedure: Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of weight loss at 12 months postoperatively
Definition: The study's single primary endpoint is the percentage of body weight loss at 12 months post-operation. It is defined as the percentage decrease in a patient's body weight from the preoperative baseline to the 12-month (±7 days) postoperative follow-up.
Objective: This endpoint serves to directly and objectively evaluate the superiority of the investigational LPG-tbROSF procedure in maintaining mid-term nutritional status compared to the standard LTG procedure.
Formula: The calculation is performed as follows:
Percentage of Weight Loss (%) = [ (Baseline Preoperative Weight - Postoperative 12-Month Weight) / Baseline Preoperative Weight ] × 100%.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260461
- Sponsor's protocol ID
- KY2025-306
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.
- ClinicalTrials.gov ID
- NCT07260461
- Acronym / sponsor ID
- KY2025-306
- Conditions
- Stomach Neoplasms, Adenocarcinoma - Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Dec 2025 (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 clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach.
The current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux.
The main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes.
The study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTG-tbROSF | Experimental | Procedure: Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)The subjects undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using the right-sided overlap and single-flap valvuloplasty (ROSF) on the tubular stomach. |
| LTG | Active comparator | Procedure: Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)Patients in the control group will undergo Laparoscopic Total Gastrectomy (LTG), and digestive tract reconstruction will be performed using a standard Roux-en-Y anastomosis. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Aged from 18 to 75 years old;
- Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;
- The tumor was located in the proximal third of the stomach.
- ECOG score of 0 or 1;
- D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).
Key exclusion criteria (13 listed)
- Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;
- Severe respiratory diseases: severe impairment of lung function (FEV1%<50%) or chronic respiratory failure;
- Severe liver and kidney dysfunction: ALT/AST > 3 times the upper limit of normal, or eGFR < 30 mL/min/1.73m²;
- patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;
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 Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)Experimental group (tbROSF group): Participants will undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using tubulized-stomach right-open single-flap valvuloplasty (tbROSF). Control group (LTG group): Participants will undergo laparoscopic total gastrectomy (LTG), with digestive tract reconstruction performed using a standard Roux-en-Y anastomosis. | Procedure or surgery | LTG, LTG-tbROSF |
Primary outcome
Percentage of weight loss at 12 months postoperatively
Time frame: From enrollment to the end of treatment at 12 months
Definition: The study's single primary endpoint is the percentage of body weight loss at 12 months post-operation. It is defined as the percentage decrease in a patient's body weight from the preoperative baseline to the 12-month (±7 days) postoperative follow-up. Objective: This endpoint serves to directly and objectively evaluate the superiority of the investigational LPG-tbROSF procedure in maintaining mid-term nutritional status compared to the standard LTG procedure. Formula: The calculation is performed as follows: Percentage of Weight Loss (%) = [ (Baseline Preoperative Weight - Postoperative 12-Month Weight) / Baseline Preoperative Weight ] × 100%.
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 3 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) in people with Stomach Neoplasms and Adenocarcinoma - Gastroesophageal Junction (GEJ), run by First Affiliated Hospital of Wenzhou Medical University.
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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact XiaoLei Chen (+86 139 6887 5558, chenxiaolei@wzhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of weight loss at 12 months postoperatively (time frame: From enrollment to the end of treatment at 12 months). 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 3 Dec 2025.