NCT06242613Enrolling by invitation
National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer
Source: ClinicalTrials.gov · Last updated 5 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 18 Jan 2023
- Start date
- 13 May 2023
- Primary completion date
- 1 Dec 2029
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06242613
What you commit to
- Study type: Observational
- Planned participants: 400
- From 13 May 2023 to the primary completion date, 1 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inoperability criteria (patient factors): serious concomitant systemic disorders incompatible with surgery or the study (at the discretion of the investigator)
- Palliative surgery cases
Other illness
- Patients undergoing surgery for gastric cancer with open approach at the beginning
Other
- 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
- Non-compliance with any of the inclusion criteria
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mª Asunción Acosta Mérida Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.