NCT03290209

Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

Randomized Controlled Trials Comparing Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）

Detailed description

Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced gastric cancer. However, some studies show that age or comorbidities is the relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself, thus affect the survial. Even with the advances in surgical techniques and care, age still is a significant risk for postoperative morbidity and mortality. Therefore, elderly patients with gastric cancer could receive minimally invasive surgery with reduced nodal dissection, i.e., D1 lymphadenectomy, in order to prevent postoperative complications. Laparoscopic surgery is a minimally invasive operation and is proved to be an acceptable alternative to open surgery. At present, there is no RCTs to confirm the safety and effectiveness of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma. This study is to compare the clinical outcomes of laparoscopic D1 versus D2 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）to evaluate the safety of laparoscopic D1 lymphadenectomy, and to verify its results in terms of survival in elderly patients with advanced gastric adenocarcinoma.

Conditions

• Stomach Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic D1 Lymphadenectomy	After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
PROCEDURE	Laparoscopic D2 Lymphadenectomy	After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-08-01
• Completion: 2023-08-01
• First posted: 2017-09-21
• Last updated: 2020-02-05

Locations

1 site across 1 country: China