Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608381
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT34a Gastric Cancer KLASS-10
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 NetworkNCCN guideline suggests total omentectomy and the European Society for Medical OncologyESMO 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
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 NetworkNCCN guideline suggests total omentectomy and the European Society for Medical OncologyESMO 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None