Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
NCT Number: NCT03524287
The purpose of this study is to explore the clinical Efficacy of robotic assisted spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma(cT2-4a, N-/+, M0).
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Fuzhou, Fujian, 350001, China
The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment.
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. However, it remains a controversial international issue if it is safe and feasible to conduct robotic assisted spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer. There is no prospective study to identify the results.
The study is through a prospective, open, single-arm study,to explore the clinical outcomes of the robotic assisted spleen-preserving No. 10 lymph node dissection in the treatment of locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Robotic assisted spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma
Time frame: 30 days
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: 9 days
Numbers of dissected No.10 lymph nodes
Time frame: 9 days
The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes)
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time frame: 1 days
The Rates of splenectomy are defined as the incidence of splenectomy within operation.
Time frame: 1 days
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 30 days
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 3, 6, 9 and 12 months
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time frame: 3, 6, 9 and 12 months
The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
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 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: 1 days
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Time frame: 1 days
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Time frame: 1 days
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Fujian Medical University
Other
Clinical Efficacy of Robotic Total Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Proximal Gastric Cancer:A Prospective Trial
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