Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    772
  • sponsor
    Yonsei University
Updated on 2 March 2022
gastrectomy
endoscopy
carcinoma
metastasis
gastric adenocarcinoma
lymphadenectomy
gastric carcinoma
adenocarcinoma
d2 lymph node dissection

Summary

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.

Details
Condition Gastric Cancer
Treatment Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach, Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
Clinical Study IdentifierNCT03385018
SponsorYonsei University
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients who have possibility of distant metastasis in preoperative studies
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
Patients who are diagnosed and treated with other malignancies within 5 years
Vulnerable patients
Patients who participating or participated in other clinical trial within 6 months
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