Status:
NOT_YET_RECRUITING
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.
Lead Sponsor:
Changzhi People's Hospital Affiliated to Changzhi Medical College
Conditions:
Proximal Early Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surge...
Detailed Description
This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo lapar...
Eligibility Criteria
Inclusion
- Age between 20 and 80 years, regardless of gender;
- Patients diagnosed with gastric cancer through tissue biopsy;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- American Society of Anesthesiologists (ASA) classification of I to III;
- Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:
- Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);
- Voluntary signing of informed consent.
Exclusion
- Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- Presence of contraindications to surgery;
- Multiple malignant lesions in the stomach;
- Presence of other malignancies that may affect the preservation of stomach function;
- Previous upper abdominal surgery (excluding cholecystectomy);
- Preoperative examination reveals active peptic ulcer;
- Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
- Pregnant or breastfeeding women;
- Conditions deemed unsuitable for participation in this study by the investigator.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT06511609
Start Date
August 1 2024
End Date
July 31 2027
Last Update
July 22 2024
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