Double-tract reconstruction after laparoscopic surgery for upper gastric cancer

Laparoscopic Proximal Gastrectomy With 'λ+α' Double-Tract Reconstruction for Upper-Third Early Gastric Cancer: A Randomized Clinical Trial.

This study is testing a new surgical method for patients with early-stage upper gastric cancer to see if it can help them recover better and avoid reflux after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (Academic / other)
• Locations: 1 site (Yangzhou)
• Trial ID: NCT06475170 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of a surgical technique called 'λ+α' double-tract reconstruction following laparoscopic proximal gastrectomy in patients with early-stage upper gastric cancer. The study aims to improve postoperative quality of life by preserving the distal stomach and preventing reflux, which is a common complication after such surgeries. Participants will undergo a specific surgical procedure designed to optimize digestive function while minimizing adverse effects. The trial will assess the outcomes and effectiveness of this approach compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with early-stage gastric cancer located in the upper third of the stomach and no distant metastasis.

Not a fit: Patients with primary tumors in other locations, distant metastasis, or significant comorbidities such as uncontrolled diabetes or coagulation disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life for patients undergoing surgery for upper gastric cancer by reducing reflux and preserving stomach function.

How similar studies have performed: While the specific 'λ+α' double-tract reconstruction method is novel, similar surgical approaches have shown promise in improving outcomes for gastric cancer patients in other studies.

Eligibility criteria

Inclusion Criteria:

Age between 18-75 years old, male or female; Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) (14) according to the eighth edition of the AJCC (15); No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT; ASA grade 1-3; Patients without contraindications to surgery; Patients and their families voluntarily signed the informed consent form and participated in the study;

Exclusion Criteria:

Patients diagnosed with primary tumors or distant metastasis; Patients whose tumor is located in the greater curvature side of the stomach; Patients with coagulation dysfunction that could not be corrected; Patients who were diagnosed with viral hepatitis and cirrhosis; Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin; Patients with organ failure such as heart, lung, liver, brain, and kidney failure; Patients with ascites or cachexia preoperatively in poor general conditions; Patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).

Patients refusing to sign the informed consent of the study;

Where this trial is running

Yangzhou

• Northern Jiangsu People'S Hospital — Yangzhou, China (Recruiting)

Study contacts

• Study coordinator: Daorong Wang

Conditions Gastric Cancer; Reflux Esophagitis