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

Changzhi People's Hospital Affiliated to Changzhi Medical College

Status: Not yet enrolling

Conditions: Proximal Early Gastric Cancer

Treatments: Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),

Study type: Interventional

Funder types: Other

Identifiers

NCT06511609

CZPH-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

double-flap technique（DFT）

Experimental group

Description:

Laparoscopic proximal gastrectomy with double flap anastomosis group

Treatment:

Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),

double-tract reconstruction（DTR）

Active Comparator group

Description:

Laparoscopic proximal gastrectomy with double-tract anastomosis group

Treatment:

Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),