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Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10)
Sponsor: Gangnam Severance Hospital
Summary
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.
Official title: Comparison Between Partial Omentectomy and Total Omentectomy During Minimally Invasive Radical Distal Gastrectomy for Clinical T3 and T4a Gastric Cancer; Multicenter Randomized Clinical Trial (KLASS-10)
Key Details
Gender
All
Age Range
20 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2024-06-26
Completion Date
2031-12-30
Last Updated
2024-09-23
Healthy Volunteers
No
Conditions
Interventions
Arm I (Total omentectomy),
The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups.
Arm II (Partial omentectomy)
The surgery is performed with minimal invasive surgery, and the range of the surgery is radical gastrectomy and D2 lymph node dissection. Depending on the random assignment, total omentectomy and partial omentectomy (omentum preservation) will be performed for the control group and the experimental group, respectively. Total omentectomy removes whole greater omentum, while partial omentectomy preserves the omentum more than 3cm away from the gastro-epiploic vessels. Other surgical procedures are the same as usual in both groups.
Locations (1)
GangnamSeverance Hospital
Seoul, South Korea