Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer
Clinical Efficacy of Robotic Total Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Proximal Gastric Cancer：A Prospective Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
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）.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
May 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedSeptember 9, 2020
September 1, 2020
1.9 years
May 2, 2018
September 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
30 days
Secondary Outcomes (19)
Numbers of No.10 lymph node dissection
9 days
Rates of positive No.10 lymph node
9 days
3-year overall survival rate
36 months
3-year disease free survival rate
36 months
3-year recurrence pattern
36 months
- +14 more secondary outcomes
Study Arms (1)
No.10 lymph node dissections
EXPERIMENTALPatients with locally advanced upper third gastric carcinoma will performed robotic assisted spleen-preserving No.10 lymph node dissections. After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Related Publications (1)
Zhong Q, Zhang ZQ, Yan YQ, Li YF, He QC, Zheng CH, Chen QY, Huang CM. [Long-term oncological safety of robotic total gastrectomy for locally advanced proximal gastric cancer: a 5-year noninferiority comparison based on the FUGES-014 study]. Zhonghua Wei Chang Wai Ke Za Zhi. 2025 Aug 25;28(8):886-894. doi: 10.3760/cma.j.cn441530-20250610-00218. Chinese.
PMID: 40850834DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changming Huang
Fujian Medical University Union Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Head of gastric surgery, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
May 2, 2018
First Posted
May 14, 2018
Study Start
March 1, 2018
Primary Completion
February 10, 2020
Study Completion
March 10, 2020
Last Updated
September 9, 2020
Record last verified: 2020-09