Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer

Fujian Medical University50 enrolled

Overview

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）.

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）.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasms

Interventions

Robotic Assisted No.10 Lymph Node DissectionsPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 to 75 years old * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * Locally advanced tumor in the upper third or middle third of stomach without invading the greater curvature (cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC (American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition) * No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) class I to III * Written informed consent Exclusion Criteria: * Pregnant and lactating women * Suffering from severe mental disorder * History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) * History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal --Dissection/Endoscopic Mucosal Resection )for gastric cancer) * Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node * History of other malignant disease within the past 5 years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within the past 6 months * History of cerebrovascular accident within the past 6 months * History of continuous systematic administration of corticosteroids within 1 month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of the predicted values * Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

overall postoperative morbidity rates

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

Secondary Outcomes

Numbers of No.10 lymph node dissection

Numbers of dissected No.10 lymph nodes

Time frame: 9 days

Rates of positive No.10 lymph node

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: 9 days

3-year overall survival rate

Time frame: 36 months

3-year disease free survival rate

Time frame: 36 months

3-year recurrence pattern

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

Time frame: 36 months

Rates of splenectomy

The Rates of splenectomy are defined as the incidence of splenectomy within operation.

Time frame: 1 days

Intraoperative morbidity rates

The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

Data from ClinicalTrials.gov

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