Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · May 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different surgical methods for treating early-stage stomach cancer located in the upper part of the stomach. One method is called laparoscopic proximal gastrectomy with a double-flap technique, which aims to reduce the risk of a common problem after surgery known as reflux esophagitis—a condition that can cause discomfort and affect a patient's quality of life. The other method being compared is laparoscopic total gastrectomy with Roux-en-Y reconstruction, which is a more traditional approach. The goal of the trial is to see which surgery has better outcomes, particularly in terms of preventing reflux issues within a year after surgery.

To participate in this trial, patients need to be adults aged between 20 and 80 with specific types of stomach cancer that are confirmed by medical tests. They should not have had major abdominal surgery in the past, and their cancer should not be too advanced. If someone joins the trial, they can expect to be randomly assigned to one of the two surgical methods. The trial will also collect information on how well each method works in the long term, aiming to provide clear evidence on the best treatment option for this type of cancer. It’s important to note that the trial is not yet recruiting participants, but it promises to contribute valuable insights into stomach cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 20 years ≤ age ≤ 80 years
• • 2. The primary gastric lesions were located in the proximal third of the stomach
• • 3. histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
• • 4. clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer(AJCC) staging system(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
• • 5. scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or laparoscopic total gastrectomy with D1+/D2 lymphadenectomy , and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
• • 6. The preoperative American Society of Anesthesiologists (ASA) physical status was I-III; The patient's cardiopulmonary function can tolerate laparoscopic surgery.
• • 7. The patients have signed the informed consent form.
• Exclusion Criteria:
• • 1. history of upper abdominal surgery (except laparoscopic cholecystectomy);
• • 2. the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
• • 3. with other malignant diseases or have suffered from other malignant diseases within 5 years
• • 4. require simultaneous surgery due to complicated with other diseases
• • 5. women are pregnant or in lactation period
• • 6. Suffering from serious mental illness
• • 7. history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month