A Multi-Institutional Chart Review to Compare the Outcomes of Robotic, Laparoscopic and Open Surgery for Gastric Cancer.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 7,000
- Locations
- 1
- Primary Endpoint
- Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.)
Study Overview
Brief Summary
Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary context in which surgery plays a main role.
Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and more recently with the spread of robotic systems, but a number of issues are currently being debated, including the limitations in performing effective extended lymph node dissections and, in this context, the real advantages of using the robotic systems, the possible role for the Advanced Gastric Cancer, the reproducibility of completely intracorporeal techniques and the oncological results achievable during follow-up.
A multicenter study with a large number of patients is now needed to further investigate the safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy and the open approach.
Detailed Description
Overall purpose:
The Overall purpose is to develop a multi-institutional database comprising information regarding surgical, clinical and oncological features of patients undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up at participating centers.
General study design:
The registry will be established by retrospectively identifying subjects with gastric cancer treated at the participating centers.
Information gathered will be obtained from existing data and records, diagnostic tests and surgical interventions.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven gastric cancer
- •Preoperative staging work-up performed by upper endoscopy / endoscopic ultrasound, and CT scan
- •Early Gastric Cancer
- •Advanced Gastric Cancer
- •Patients treated with curative intent in accordance to international guidelines
Exclusion Criteria
- •Locally advanced tumor infiltrating neighboring organs
- •Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
- •Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score ≥
- •History of gastric surgery
- •Remnant gastric cancer
- •Synchronous other major abdominal surgery
- •Synchronous malignancy in other organs
- •Palliative surgery cases
Outcomes
Primary Outcomes
Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.)
Time Frame: Assessment at 1, 3, 5 years from surgery.
Overall survival.
Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.)
Time Frame: Intraoperative.
Intraoperative complications.
Verify the respect of oncological principles through minimally invasive approaches in relation to the stage and location of the tumor by comparing results with open surgery. (Number of lymph nodes retrieved.)
Time Frame: Intraoperative.
Number of lymph nodes retrieved.
Compare the three treatment arms in terms of recovery of gastrointestinal functions and physical status allowing the discharge of the patient. (Days of hospitalization after surgery until discharge.)
Time Frame: Assessment during an average period of 10 days after surgery.
Days of hospitalization after surgery until discharge.
Compare the incidence, types and severity of early postoperative complications after gastrectomy by the three approaches. (Score based on the Clavien-Dindo classification system.)
Time Frame: Assessment during an average period of 10 days after surgery.
Score based on the Clavien-Dindo classification system.
Compare the three treatment arms in terms of tumor recurrence after treatment. (Disease-free survival)
Time Frame: Assessment at 1, 3, 5 years from surgery.
Disease-free survival.
Secondary Outcomes
- Verify the safety of intracorporeal anastomosis in comparison with extracorporeal anastomosis. (Anastomotic leakage)(Assessment during an average period of 10 days after surgery.)
- Verify whether robotic gastrectomy, compared with laparoscopic or open techniques, is capable of improving postoperative surgical stress. (Granulocyte-to-lymphocyte ratio.)(Assessment during an average period of 10 days after surgery.)
- Compare the intracorporeal anastomosis with the extracorporeal anastomosis to evaluate post-operative recovery. (Days of hospitalization after surgery until discharge.)(Assessment during an average period of 10 days after surgery.)
Investigators
Amilcare Parisi
Dr.
Azienda Ospedaliera Santa Maria, Terni, Italy