A Phase 2 interventional study of Laparoscopic D1 Lymphadenectomy and Laparoscopic D2 Lymphadenectomy in Stomach Neoplasm, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Fujian Medical University · Phase 2, Interventional, and Treatment
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）
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.
Exclusion Criteria:
Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic D1 Lymphadenectomy
Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic D2 Lymphadenectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.
3-year disease specific survival rate
the rate of 3-year disease specific survival
Time frame: 36 months
3-year overall survival rate
the rate of 3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
the rate of 3-year disease free survival
Time frame: 36 months
number of retrieved lymph nodes
number of retrieved lymph nodes
Time frame: 1 day
number of positive lymph nodes
number of positive lymph nodes
Time frame: 1 day
intraoperative blood loss
intraoperative blood loss
Time frame: 1 day
the rate of conversion to laparotomy
the rate of conversion to laparotomy
Time frame: 1 day
overall postoperative morbidity rate
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Time frame: 30 days
overall postoperative mortality rate
the rate of surgical mortality
Time frame: 30 days
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 30 days
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of prealbumin
The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
operation time
operation time
Time frame: 1 day
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Fujian Medical University