Status:
RECRUITING
Comparison Partial Versus Total Omentectomy in Minimal Invasive Distal Gastrectomy for cT3/4a Gastric Cancer (KLASS-10)
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
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 gastre...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Confirmed distant metastasis in preoperative examinations
- Confirmed metastasis in abdominal cavity or distant organs during surgery
- Confirmed no infiltration of the serosa layer or unable to confirm the tumor location during surgery (sT1-2)
- Confirmed invasion of surrounding organs (sT4b)
- History of previous gastrectomy or greater omentum related surgery
- Patients who underwent preoperative treatment (chemotherapy, radiotherapy, or endoscopic submucosal dissection) for recently diagnosed gastric cancer
- Synchronous or metachronous malignancies, which underwent surgery, chemotherapy or radiotherapy within 5 years
- Patients judged to be inappropriate for the study by the physician. (ex. Pregnancy)
- Patients refused to participate after random assignment
- Surgery is not performed until 30 days after consenting to participate
- Patients who has participated in another on-going clinical trial, which is related surgical procedures and survival.
Key Trial Info
Start Date :
June 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2031
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT06608381
Start Date
June 26 2024
End Date
December 30 2031
Last Update
September 23 2024
Active Locations (1)
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1
GangnamSeverance Hospital
Seoul, South Korea