Actively Recruiting
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
Led by Fudan University · Updated on 2022-09-13
600
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
CONDITIONS
Official Title
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastric adenocarcinoma in the upper or middle third of the stomach
- Age between 20 and 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Clinical stage I-III (T1-4aN0-2M0) based on gastrofiberscopy and abdominal CT
- Planned total gastrectomy with D2 lymphadenectomy aiming for complete tumor removal (R0 surgery)
- Written informed consent
- No prior chemotherapy or radiotherapy before surgery
You will not qualify if you...
- Clinical stage T1-4N3M0 or T4bN0-3M0
- History of chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- Perigastric lymph node larger than 3 cm
- Previous gastric surgery such as gastrectomy or gastrojejunostomy
- Presence of multiple primary tumors
- Serious other diseases including cardiovascular, respiratory, kidney, liver diseases, or poorly controlled hypertension, diabetes, or mental disorders
- Need for emergency operation due to gastric cancer complications
- Abdominal adhesions from prior surgery
- Requirement for combined organ resection due to tumor spread or other disease
- Unable to communicate or vulnerable individuals, pregnant or planning pregnancy
- Participation in other clinical trials within the last 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Dazhi Xu, PHD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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