NCT03385018Recruiting
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Source: ClinicalTrials.gov · Last updated 19 Mar 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses. Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery. Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 772 (estimated)
- First submitted
- 20 Dec 2017
- Start date
- 5 Apr 2018
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Yonsei University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03385018
What you commit to
- Study type: Interventional
- Planned participants: 772
- From 5 Apr 2018 to the primary completion date, 31 Dec 2022
- 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
- Patients who are diagnosed and treated with other malignancies within 5 years
Other illness
- Patients who have history of gastric resection with any cause
- Patients who have complications (bleeding or obstruction) of gastric cancer
- Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
Other
- Patients who have possibility of distant metastasis in preoperative studies
- Vulnerable patients
- Patients who participating or participated in other clinical trial within 6 months
Who the study is looking for
- Patients who are over 20 and below 80 years old
- Patients who have performance status of ECOG 0 or 1
- Patients with American Society of Anesthesiology score of class I to III
- Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
- Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
- Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 \~ cT4a)
- Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 \~ cN2)
- Patients who agree with participating in the clinical study with informed consents
- Patients who can be followed for at least 3 years after study enrollment
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 |
|---|---|---|---|
| Department of Surgery, Yonsei University College of Medicine, Seoul, Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.