Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes (IMIGASTRICII)

International Study Group on Minimally Invasive Surgery for Gastric Cancer

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Procedure: Robotic Gastrectomy; Procedure: Laparoscopic Gastrectomy

Study type: Observational

Funder types: Other

Identifiers

NCT02751086

002

Details and patient eligibility

About

The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.

The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.

Full description

A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:

Small samples of patients, mostly low-quality comparative studies Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy) Absence of subgroup analysis in significant research fields Lack of information on the surgical techniques adopted

A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:

Achieving a large sample of patients Collecting multiple variables, allowing for the making of a comprehensive statistical report Standardizing the methodology to be adopted, thus increasing accuracy Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven gastric cancer
• Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
• Early Gastric Cancer
• Advanced Gastric Cancer
• Patients treated with curative intent in accordance to international guidelines

Exclusion criteria

• 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 > 4
• History of previous abdominal surgery for gastric cancer
• Synchronous malignancy in other organs
• Palliative surgery

Trial design

5,000 participants in 3 patient groups

Robotic Gastrectomy

Description:

Patients who will be treated for gastric cancer with the assistance of the robotic surgical system

Treatment:

Procedure: Robotic Gastrectomy

Laparoscopic Gastrectomy

Description:

Patients who will be treated for gastric cancer through laparoscopic devices.

Treatment:

Procedure: Laparoscopic Gastrectomy

Open Gastrectomy

Description:

Patients who will be treated for gastric cancer with traditional open surgery.