Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach | Procedure | — | UNRESOLVED |
| Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laparoscopic group
- description
- Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection
- interventionNames
- Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
- type
- ACTIVE_COMPARATOR
- label
- Open group
- description
- Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection
- interventionNames
- Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
Primary outcomes (1)
- measure
- 3 year relapse-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available