NCT05235932Not yet recruiting
the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
Source: ClinicalTrials.gov · Last updated 11 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 10 Feb 2022
- Start date
- 20 Feb 2022
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Fujian Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05235932
What you commit to
- Study type: Interventional
- Planned participants: 570
- From 20 Feb 2022 to the primary completion date, 20 Feb 2024
- 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
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy(except for ESD/EMR for gastric cancer )
- History of previous neoadjuvant chemotherapy or radiotherapy
Other illness
- Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
- Severe mental disorder
- History of other malignant disease within the past five years
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
Other
- Women during pregnancy or breast-feeding
- Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
- FEV1 (forced expiratory volume in one second)\<50% of predicted values
Who the study is looking for
- 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
- 3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
- 5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.