Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-27 @ 7:22 AM
Study NCT ID:
NCT07260461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of weight loss at 12 months postoperatively', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': "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.\n\nObjective: 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.\n\nFormula: The calculation is performed as follows:\n\nPercentage of Weight Loss (%) = \\[ (Baseline Preoperative Weight - Postoperative 12-Month Weight) / Baseline Preoperative Weight \\] × 100%."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasms', 'Adenocarcinoma - Gastroesophageal Junction (GEJ)', 'Gastroesophageal Junction Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach.\n\nThe 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.\n\nThe 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.\n\nThe study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged from 18 to 75 years old;\n2. Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;\n3. The tumor was located in the proximal third of the stomach.\n4. ECOG score of 0 or 1;\n5. D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).\n6. ASA grade I to III;\n7. The preoperative nutritional status of the patients was good without severe malnutrition.\n8. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. 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);\n2. Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;\n3. Severe respiratory diseases: severe impairment of lung function (FEV1%\\<50%) or chronic respiratory failure;\n4. Severe liver and kidney dysfunction: ALT/AST \\> 3 times the upper limit of normal, or eGFR \\< 30 mL/min/1.73m²;\n5. patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;\n6. Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.\n7. Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;\n8. Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;\n9. Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);\n10. Pregnant or lactating women;\n11. Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;\n12. Severe malnutrition before surgery: BMI \\< 16 kg/m² or albumin \\< 25 g/L;\n13. Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).'}, 'identificationModule': {'nctId': 'NCT07260461', 'briefTitle': 'The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'KY2025-306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LTG-tbROSF', 'description': '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.', 'interventionNames': ['Procedure: Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LTG', 'description': '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.', 'interventionNames': ['Procedure: Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)']}], 'interventions': [{'name': 'Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)', 'type': 'PROCEDURE', 'description': 'Experimental group (tbROSF group): Participants will undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using tubulized-stomach right-open single-flap valvuloplasty (tbROSF).\n\nControl group (LTG group): Participants will undergo laparoscopic total gastrectomy (LTG), with digestive tract reconstruction performed using a standard Roux-en-Y anastomosis.', 'armGroupLabels': ['LTG', 'LTG-tbROSF']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'XiaoLei Chen', 'role': 'CONTACT', 'email': 'chenxiaolei@wzhospital.cn', 'phone': '+86 139 6887 5558'}, {'name': 'DongDong Huang', 'role': 'CONTACT', 'email': 'hdd0577@163.com', 'phone': '+86 136 7649 3292'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}