Gastric Cancer
Conditions
Brief summary
The aim of this study is to show better postoperative quality of life including lower incidence of dumping syndrome and comparable survival after laparoscopic pylorus preserving gastrectomy (LPPG), compared to laparoscopic distal gastrectomy (LDG) in patients with middle-third early gastric cancer
Detailed description
Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated. Patients Registration It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms. After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Hospital Medical Research Collaborating Center. Each group 128 patients, total 256 subjects will be enrolled. Randomization The registration randomization should be done with 1:1 ratio for each researcher. Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table. Procedure Operations are performed according to the allocated group.
Interventions
PROCEDURELaparoscopic PPG
Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
PROCEDURELaparoscopic DG
Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients are included in the trial if they meet all of the following criteria: * histologically proven primary gastric adenocarcinoma * aged 20-80 years old * performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale * performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score * clinical stage T1N0M0, which are assessed by endoscopic ultrasound or computed tomography (CT) scan (AJCC 7th classification) * location of primary tumor; middle third of stomach (more than 5cm away from the pylorus) * written signed informed consent
Exclusion criteria
Patients are excluded if they meet any of the following criteria: * pyloric deformity because peptic ulcer disease * previous gastric surgery (e.g. gastro-jejunostomy, primary closure) * synchronous lesion of early gastric cancer or adenoma in antrum * prior treatment of endoscopic submucosal dissection, chemotherapy or radiation therapy against any other malignancies * patients who need combined resection (eg. cholecystectomy) * vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women) * participated in another clinical trial within the last six months or currently involved patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dumping syndrome, assessed by Sigstad score (≥7) | 1 years postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years postoperatively |
| Operative morbidity | 30 days for early morbidity |
| Operative mortality | mortality for 90 days |
| Body weight change | check at every visit up to 3 years postoperatively |
| Fat volume change on abdominal CT scan | check at every 1 year up to 3 years postoperatively |
| Relapse-free survival | 3 years postoperatively |
| Change of Protein | check at every visit up to 3 years postoperatively |
| Change of Albumin | check at every visit up to 3 years postoperatively |
| QOL measurement (EORTC C30/STO22) (composite) | 6 month, 1 year, 2 year, 3 year postoperatively |
| Incidence of gallbladder stone | check at every 6 months up to 3 years postoperatively |
| Gross and microscopic changes measured by gastroscopy (composite) | 1 year, 2 year, 3 year postoperatively |
| Change of Hemoglobin | check at every visit up to 3 years postoperatively |
Countries
South Korea
Outcome results
None listed