National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer

NCT06242613 | Enrolling By Invitation

• 1 other identifier: ROBOTAG
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years there has been a rapid incursion of robotic technology applied to almost all fields of surgery. In gastric cancer, whose mainstay of treatment is still surgical resection, gastrectomy with robotic lymphadenectomy is growing faster than the scientific evidence supporting its results. The "National Multicenter Cohort Study of ROBOT-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer" (ROBOTAG study) is proposed as a prospective multicenter Spanish nationwide study, comparing robotic gastrectomy versus conventional laparoscopic gastrectomy for the treatment of gastric cancer. This study aims to provide evidence on the feasibility, safety and complications, possible technical advantages, short and long term surgical and oncological results, as well as aspects related to quality of life, which can support the increase in cost and the important technological effort that underlies robotic surgery with respect to conventional laparoscopic access. The relevance of this project is doubled by directing the objectives, on the one hand, on a new and expensive technology that is reaching hospitals still surrounded by controversy about its real benefits; and on the other hand, by acting on a pathology for which most of the available studies come from Eastern countries, sometimes not very applicable to the Western context.

Conditions

Gastric Cancer

Keywords

Gastrectomy; Lymphadenectomy; Robotic Surgery; Laparoscopic Surgery; Robot Assisted Gastrectomy; Laparoscopic Gastrectomy; Gastric Surgery; Minimally Invasive Gastrectomy; Robotic Gastrectomy

Outcome Measures

Primary Outcomes (2)

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of clinical safety.

  Intraoperative blood loss and perioperative complications (types of complications, Clavien Dindo classification, Comprehensive Complication Index (CCI®))

  Intraoperative and Postoperative (up to 90 days postoperative)

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of oncologic safety.

  Nodal count (number of lymph nodes retrieved) and R0 resection margin.

  Intraoperative

Secondary Outcomes (4)

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of intraoperative outcomes.

  Intraoperative

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of recovery and postoperative physical status.

  Postoperative, up to 1 year after surgery

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of oncological outcomes.

  Assessment at 1, 3, 5 years from surgery

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of cost-utility outcomes.

  Assessment at 1 year from surgery

Study Arms (2)

Robotic Surgery

Patients underwent gastric surgery through the use of a robotic system.

Procedure: Robot-Assisted Gastrectomy

Laparoscopic Surgery

Patients underwent gastric surgery with laparoscopic procedures.

Procedure: Laparoscopic Gastrectomy

Interventions

Robot-Assisted Gastrectomy PROCEDURE

Gastrectomy performed with a robotic system.

Robotic Surgery

Laparoscopic Gastrectomy PROCEDURE

Gastrectomy performed with conventional laparoscopic approach.

Laparoscopic Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those patients with a diagnosis of gastric adenocarcinoma, histologically confirmed, whose preoperative extension study is compatible with stages IB, II and III of the 8th edition of the TNM classification (AJCC), in whom there is an indication for surgical treatment with curative intent by minimally invasive gastrectomy (RAG or LG), with or without neoadjuvant treatment, will be considered for the study.

You may qualify if:

• Histologically confirmed primary gastric adenocarcinoma
• Clinical stages Ib, II and III of gastric cancer (8th edition of the TNM classification)
• Patients with ECOG Performance Status 0, 1 or 2
• Patients who sign the informed consent to participate in the study
• Patients over 18 years old
• Patients treated by surgery with curative intent
• Patients must be suitable for surgery.

You may not qualify if:

• Any histology other than adenocarcinoma
• Stage Ia and IV
• Unresectability criteria (tumor factors): distant metastasis, peritoneal carcinomatosis, positive cytology of ascitic fluid, invasion or tumor entrapment of large vessels (aorta, liver, celiac trunk), infiltration of the root of the mesentery, para-aortic lymphadenopathy or levels \>3, linitis plastica, involvement of other organs
• Inoperability criteria (patient factors): serious concomitant systemic disorders incompatible with surgery or the study (at the discretion of the investigator)
• Patients undergoing surgery for gastric cancer with open approach at the beginning
• Palliative surgery cases

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Mª Asunción Acosta Mérida

Las Palmas de Gran Canaria, Las Palmas, 35000, Spain

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Mª Asunción Acosta Mérida, MD. PhD.

  Department of General and Digestive Surgery, Dr. Negrin University Hospital of Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 5, 2024
• Study Start: May 13, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

ES (1)