Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes

International Study Group on Minimally Invasive Surgery for Gastric Cancer

Status

Unknown

Conditions

Gastric Cancer

Treatments

Procedure: Robotic Surgery

Procedure: Laparoscopic Surgery

Procedure: Open Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT02325453

001

Details and patient eligibility

About

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.

Full 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.

Information will be collected and recorded by all institutes through a specific online shared system.

Main objectives:

To determine the surgical, clinical, and oncological outcomes in both the short and long term
To compare results according to the type of intervention, device used and manner of execution of different surgical phases
To relate results of different surgeries with baseline characteristics of patients and stage of disease

Clinical relevance:

Studies that reported results of minimally invasive surgery for gastric cancer and recent meta-analysis emphasize the need for large trials.

A further consideration in this field regards the need of numerous patients to reach a statistical significance on surgical, clinical and oncological outcomes, in order to fully assess the effectiveness and the differences between the different surgical approaches.

At present, a multicenter registry may represent the best research tool to assess the role of minimally invasive approaches by comparing the methods with traditional open surgery.

Therefore, for this project, a large registry will be created by collecting data from the different participating centers to create a working basis for analyzing outcomes of interest and obtaining directions for further investigation.

The data collected will clarify the role of laparoscopic and robotic surgery versus the open approach in terms of:

safety and feasibility based on the intraoperative outcomes
respect of oncological principles in relation to the stage and location of the tumor
recovery of gastrointestinal function considering the outcomes measured during the postoperative hospital stay
incidence, types and severity of postoperative complications
overall survival and disease-free survival

Duration of study:

The beginning of the trial is scheduled for January 2015. It is expected to end the chart review within one year.

Type of data collection:

In the present study, the following information will be collected:

Patient Demographics
Surgical Procedure details
Tumor characteristics
Operative findings
Post-operative clinical findings
Post-operative complications
Follow-up details

Statistical analysis:

The dichotomous variables will be expressed as numbers and percentages, while continuous variables will be expressed as mean and standard deviation (SD) or median and interquartile range (minimum and maximum values).

Continuous variables, will be compared using one-way ANOVA with post hoc multiple comparison by Tukey's procedure. Pearson's χ2 test or Fisher's exact test, as appropriate, will be used for analysis of categorical data.

For each of these tests a value of alpha (α) < 0.05 will be considered statistically significant.

Potential risks and safety management:

Participation in the research registry involves the potential risks of a breach of confidentiality of the medical record information and associated privacy of the participants.

Such risks will be minimized by the use and the establishment of appropriate information technology services.

Enrollment

7,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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 ≥4.
History of gastric surgery
Remnant gastric cancer
Synchronous other major abdominal surgery
Synchronous malignancy in other organs
Palliative surgery cases