The study will be presented at the 11th International Gastric Cancer Congress to be held in Sao Paulo (June 04-06th, 2015).
This will be the opportunity to meet participating Institutes and spread the objectives of the project.
Accepted Abstract:
Establishing a multi-institutional registry to compare the outcomes of robotic, laparoscopic and open gastrectomy for : IMIGASTRIC study
Background
Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary management 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 use of the robotic system. 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 total intracorporeal techniques and the oncological results achievable during long-term follow-up. This multi-institutional project aimed to create the most extensive international database of patients receiving distal, subtotal or total gastrectomy using the robotic, laparoscopic or open approach performed at Institutions with experience in gastric and minimally invasive surgery.
Method
A study protocol was developed and shared between 18 international centers. A registry was launched for collection of data. The overall purpose is to develop and maintain an ongoing comprehensive multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients undergoing surgery for gastric cancer with subsequent short- and long-term follow-up.
Main Objectives
-To determine short- and long-term surgical, clinical, and oncological outcomes;
-To compare results according to the type of intervention and surgical approaches;
-To relate results of different surgeries with the patients baseline characteristics and stage of disease.
General Study Design
The first step of the project (NCT02325453) was started, creating a retrospective chart review database. An online software system was established through a dedicated website. The database is the first of its kind, through an international electronic submission system and an HIPA protected real time data repository.
Conclusion
A multicenter study with a large number of patients is now needed to further investigate the safety and efficacy as well as the long-term outcomes of robotic surgery, laparoscopy and the open approach for the management of gastric cancer. The IMIGASTRIC study opened in May 2015 at the original participating sites in nine countries. Other centers are invited to join the study.
