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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: f
View:

• Histologically proven adenocarcinoma of the stomach

• Age between 20 to 85 years old

• ECOG PS 0-1, ASA class I-III

• Endoscopically Borrmann type I, II, III

• Clinical T3 and T4a tumors with or without regional lymph node metastases (cT3N0M0\

⁃ T4aN3M0)

• Capable of minimal invasive radical subtotal gastrectomy with R0 resection in preoperative examinations

• Patients who signed an written consent form approved by the Institutional Review Board(IRB) after receiving sufficient explanations of the contents of the clinical trial

• Domestic patients who are able to follow up for 3 years after surgery

Locations
Other Locations
Republic of Korea
GangnamSeverance Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2031-12-30
Participants
Target number of participants: 440
Treatments
Active_comparator: Total omentectomy group
During minimally invasive radical gastrectomy and D2 lymph node dissection, total omentectomy will be performed.
Experimental: Partial omentectomy group
During minimally invasive radical gastrectomy and D2 lymph node dissection, partial omentectomy will be performed.
Sponsors
Leads: Gangnam Severance Hospital

This content was sourced from clinicaltrials.gov