The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.

Not Applicable

Not yet recruiting

• Conditions: Proximal Early Gastric Cancer
• Interventions: Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),

• Registration Number: NCT06511609
• Lead Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College

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 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Study Start: 2024-08-01
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 244

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double-flap technique（DFT）	double-flap technique（DFT）; double-tract reconstruction(DTR),	Laparoscopic proximal gastrectomy with double flap anastomosis group
double-tract reconstruction（DTR）	double-flap technique（DFT）; double-tract reconstruction(DTR),	Laparoscopic proximal gastrectomy with double-tract anastomosis group

Primary Outcome Measures

Name	Time	Method
Proportion of patients with reflux esophagitis	Within 12 months after surgery	The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Within 12 months after surgery	Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.
Weight change	Within 12 months after surgery	Calculated in kilograms
Kamikawa anastomosis time	Perioperative period	The time of making the seromuscular flap and the time of esophagogastrostomy were included
intraoperative blood loss	Perioperative period	The operation begins to end the amount of bleeding.
Operation time	Perioperative period	From the beginning of surgery to the end of surgery
Ferritin value	Within 12 months after surgery	The concentration of Vitamin B12 value in the blood, expressed in ug/L.
Albumin value	Within 12 months after surgery	The concentration of albumin in the blood, expressed in g/L.
Pre albumin value	Within 12 months after surgery	The concentration of pre albumin in the blood, expressed in g/L.
Folic acid value	Within 12 months after surgery	The concentration of Folic acid value in the blood, expressed in ng/mL.
Vitamin B12 value	Within 12 months after surgery	The concentration of Vitamin B12 value in the blood, expressed in uug/L.
Hemoglobin value	Within 12 months after surgery	The concentration of Hemoglobin in the blood, expressed in g/L.
Nutritional risk screening 2002	Within 12 months after surgery	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.
Body Mass Index (BMI)	Within 12 months after surgery	weight and height will be combined to report BMI in kg/m\^2