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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | From enrollment to the end of treatment at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XiaoLei Chen | Contact | +86 139 6887 5558 | chenxiaolei@wzhospital.cn | |
| DongDong Huang | Contact | +86 136 7649 3292 | hdd0577@163.com |
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|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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