NCT05537129Recruiting
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
Source: ClinicalTrials.gov · Last updated 13 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 8 Sept 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05537129
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 1 Oct 2022 to the primary completion date, 1 Oct 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
- received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
- adhesion due to the previous intraabdominal surgery
Other illness
- clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
- history of chemotherapy, radiotherapy, immunotherapy or target therapy
- suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- patients need emergency operation with complication of gastric cancer
- need for combined organ resection due to aggression of gastric cancer of other disease,
Other
- perigastric lymphnode≥3cm
- multiple primary tumors
- vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
- currently participating or participated in other clinical trials in the last 6 months
Who the study is looking for
- histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
- age between 20 and 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
- scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
- written informed consent
- without preoperative chemotherapy and radiotherapy
Age in the registry: 20 years to 80 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 |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.