Actively Recruiting
Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10)
Led by Gangnam Severance Hospital · Updated on 2024-09-23
440
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For advanced gastric cancer, surgical resection is the only curable therapeutic strategy. According to minimally invasive approach is adopted in various field of oncologic surgery, laparoscopic gastrectomy with lymph node dissection is becoming a standard not only for early gastric cancer but also for advanced gastric cancer. The greater omentum is an organ is known to play a role in removing bacteria in the abdominal cavity as a primary defense. Complete resection of the greater omentum has been considered essential to ensure the elimination of micrometastasis during surgery for advanced gastric cancer. However, the oncological effect of total omentectomy is still lack of evidence. Especially in minimal invasive gastrectomy, total omentectomy procedure is known to increases the operating time, increase the risk of bleeding, colonic injury, and postoperative complications such as intra-abdominal abscess, ascites, anastomotic leakage, ileus and wound infections. Therefore, in the case of minimal invasive surgery in early gastric cancer, omentectomy is omitted usually or routinely. Partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Advanced energy devices facilitate partial omentectomy during laparoscopic gastrectomy. According to the Japanese Gastric Cancer Treatment Guidelines, partial omentectomy (omentum preservation) is feasible for T1 or T2 tumors, and total omentectomy is recommended for clinical T3 or deeper tumors. However, the National Comprehensive Cancer Network(NCCN) guideline suggests total omentectomy and the European Society for Medical Oncology(ESMO) guideline does not mentioned about it. It is still controversial whether total omentectomy should be performed in advanced gastric cancer. Therefore, we aimed to verify the non-inferiority of partial omentectomy, oncologic safety compared with total omentectomy via multicenter randomized clinical trial.
CONDITIONS
Official Title
Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven adenocarcinoma of the stomach
- Age between 20 to 85 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- American Society of Anesthesiologists (ASA) class I-III
- Endoscopically confirmed Borrmann type I, II, or III gastric cancer
- Clinical tumor stage T3 or T4a with or without regional lymph node metastases (cT3N0M0 to T4aN3M0)
- Suitable for minimally invasive radical subtotal gastrectomy with the intent of complete tumor removal (R0 resection) based on preoperative evaluation
- Signed informed consent approved by the Institutional Review Board after full explanation
- Able to follow up for 3 years after surgery as a domestic patient
You will not qualify if you...
- Presence of distant metastasis found in preoperative exams
- Metastasis in the abdominal cavity or distant organs found during surgery
- No serosal layer invasion or undetermined tumor location during surgery (clinical stage T1-2)
- Invasion of surrounding organs (clinical stage T4b)
- History of previous gastrectomy or surgery involving the greater omentum
- Received preoperative treatment such as chemotherapy, radiotherapy, or endoscopic submucosal dissection for recent gastric cancer diagnosis
- Other cancers treated with surgery, chemotherapy, or radiotherapy within the past 5 years
- Deemed inappropriate for the study by a physician (e.g., pregnancy)
- Declined participation after random assignment
- Surgery not performed within 30 days after consenting
- Currently participating in another ongoing clinical trial related to surgery or survival
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Trial Site Locations
Total: 1 location
1
GangnamSeverance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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