Clinical trial NCT06511609: The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.
Official title: Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Proximal Early Gastric Cancer
Lead sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 244
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of patients with reflux esophagitis
timeFrame: Within 12 months after surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: Within 12 months after surgery
measure: Operation time
timeFrame: Perioperative period
measure: Kamikawa anastomosis time
timeFrame: Perioperative period
measure: intraoperative blood loss
timeFrame: Perioperative period
measure: Weight change
timeFrame: Within 12 months after surgery
measure: Body Mass Index (BMI)
timeFrame: Within 12 months after surgery
measure: Albumin value
timeFrame: Within 12 months after surgery
measure: Pre albumin value
timeFrame: Within 12 months after surgery
measure: Hemoglobin value
timeFrame: Within 12 months after surgery
measure: Folic acid value
timeFrame: Within 12 months after surgery
measure: Vitamin B12 value
timeFrame: Within 12 months after surgery
measure: Ferritin value
timeFrame: Within 12 months after surgery
measure: Nutritional risk screening 2002
timeFrame: Within 12 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: 502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China
name: WenQing Hu
role: STUDY_CHAIR
References: