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Trial Title:
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.
NCT ID:
NCT06511609
Condition:
Proximal Early Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
double-flap technique（DFT）; double-tract reconstruction(DTR),
Description:
DFT (experiment group). Patients receive double flap technique after laparoscopic
proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction
after laparoscopic proximal gastrectomy.
Arm group label:
double-flap technique（DFT）
Arm group label:
double-tract reconstruction（DTR）
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 surgery is non-inferior for the DFT group compared to the DTR
group.
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 laparoscopic proximal gastrectomy with double-flap technique (DFT)
anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with
double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who
develop reflux esophagitis within 12 months after surgery. The secondary endpoints
include postoperative complications, surgery-related indicators, and postoperative
nutritional status.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between 20 and 80 years, regardless of gender;
2. Patients diagnosed with gastric cancer through tissue biopsy;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. American Society of Anesthesiologists (ASA) classification of I to III;
5. 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);
6. Voluntary signing of informed consent.
Exclusion Criteria:
1. Received preoperative chemotherapy, radiotherapy, targeted therapy, or
immunotherapy;
2. Presence of contraindications to surgery;
3. Multiple malignant lesions in the stomach;
4. Presence of other malignancies that may affect the preservation of stomach function;
5. Previous upper abdominal surgery (excluding cholecystectomy);
6. Preoperative examination reveals active peptic ulcer;
7. Patients who have received or are currently receiving treatment for systemic
inflammatory diseases;
8. Pregnant or breastfeeding women;
9. Conditions deemed unsuitable for participation in this study by the investigator.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
August 1, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Changzhi People's Hospital Affiliated to Changzhi Medical College
Agency class:
Other
Source:
Changzhi People's Hospital Affiliated to Changzhi Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511609
