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

I

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.

Trial contacts and locations

1

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Central trial contact

Jacopo Desiderio, MD

Data sourced from clinicaltrials.gov

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