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

NCT ID: NCT06511609

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-07-31

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.

Conditions

Proximal Early Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

double-flap technique（DFT）

Laparoscopic proximal gastrectomy with double flap anastomosis group

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

double-tract reconstruction（DTR）

Laparoscopic proximal gastrectomy with double-tract anastomosis group

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changzhi People's Hospital Affiliated to Changzhi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WenQing Hu

Role: STUDY_CHAIR

502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China

Central Contacts

WenQing Hu, Dr.

Role: CONTACT

beibeihejiyy@163.com

03552066898

Other Identifiers

CZPH-0001

Identifier Type: -

Identifier Source: org_study_id