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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double-flap technique（DFT） | Experimental | Laparoscopic proximal gastrectomy with double flap anastomosis group |
|
| double-tract reconstruction（DTR） | Active Comparator | Laparoscopic proximal gastrectomy with double-tract anastomosis group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| double-flap technique（DFT）; double-tract reconstruction(DTR), | Procedure | DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with reflux esophagitis | The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group. | Within 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications. | Within 12 months after surgery |
| Operation time | From the beginning of surgery to the end of surgery |
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Inclusion Criteria:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WenQing Hu, Dr. | Contact | 03552066898 | beibeihejiyy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| WenQing Hu | 502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China | Study Chair |
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| Perioperative period |
| Kamikawa anastomosis time | The time of making the seromuscular flap and the time of esophagogastrostomy were included | Perioperative period |
| intraoperative blood loss | The operation begins to end the amount of bleeding. | Perioperative period |
| Weight change | Calculated in kilograms | Within 12 months after surgery |
| Body Mass Index (BMI) | weight and height will be combined to report BMI in kg/m^2 | Within 12 months after surgery |
| Albumin value | The concentration of albumin in the blood, expressed in g/L. | Within 12 months after surgery |
| Pre albumin value | The concentration of pre albumin in the blood, expressed in g/L. | Within 12 months after surgery |
| Hemoglobin value | The concentration of Hemoglobin in the blood, expressed in g/L. | Within 12 months after surgery |
| Folic acid value | The concentration of Folic acid value in the blood, expressed in ng/mL. | Within 12 months after surgery |
| Vitamin B12 value | The concentration of Vitamin B12 value in the blood, expressed in uug/L. | Within 12 months after surgery |
| Ferritin value | The concentration of Vitamin B12 value in the blood, expressed in ug/L. | Within 12 months after surgery |
| Nutritional risk screening 2002 | The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status. | Within 12 months after surgery |