Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery (CGCT-01)
Gastric Cancer, Surgery, Ultrasonic Scalpel
About this trial
This is an interventional prevention trial for Gastric Cancer focused on measuring Stomach Neoplasms, Operative Time, Gastrectomy, Surgical Hemorrhage, Mortality, Morbidity
Eligibility Criteria
Inclusion Criteria:
- Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of traditional open D2 distal gastrectomy;
- Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT2N0M0-T4aN3M0, IB-IIIC, except T4b;
- Age:≤75 years, or ≥18 years;
- Without serious disease;
- Patients without previous history of upper abdominal surgery;
- WHO performance score <2;
- No limit to sexual and race;
- informed consent required;
Exclusion Criteria:
- primary lesion cannot be resected in the pattern of transabdominal distal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection (include the cholecystectomy) or with a transthoracic approach surgery;
- Patient undergo emergency surgery due to bleeding or perforation;
- Patients with other gastric malignant diseases, such as lymphoma and stromal tumors, etc;
- Patients suffering from malignant diseases before the study;
- Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe Chronic Obstruction Pulmonary Disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
- Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- Severity mental diseases;
- After signature the Clinical trial agreement, patients and their agent will quit the trial.
Sites / Locations
- Peking University Cancer Hospital and InstituteRecruiting
- Guangdong General Hospital
- The Third Affiliated Hospital, Harbin Medical University
- Union Hospital, Tongji Medical College
- The First Affiliated Hospital of China Medical University
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- Zhongshan Hospital, Fudan University
- West China Hospital, Sichuan UniversityRecruiting
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Ultrasonic scalpel surgery group
Monopolar electrocautery surgery group
During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock.
During the procedures of the abdominal approach D2 distal gastrectomy, use monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock.