Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy

Not Applicable

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Laparoscopic PPG	Laparoscopic PPG	Laparoscopy assisted pylorus-preserving gastrectomy(LPPG) with D1+ lymphadenectomy is performed (exclude lymph node station No. 5) in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Extra-corporeal gastro-gastrostomy should be performed
Laparoscopic DG	Laparoscopic DG	Laparoscopic distal gastrectomy(LDG) with D1+ lymphadenectomy in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. Anastomosis method (extra-corporeal or intra-) and reconstruction type (Billroth I (gastroduodenostomy), Billroth II, or Roux-en Y gastrojejunostomy) are optional according to the surgeon's preference

Primary Outcome Measures

Name	Time	Method
Incidence of Dumping syndrome, assessed by Sigstad score (≥7)	1 years postoperatively

Secondary Outcome Measures

Name	Time	Method
Incidence of gallbladder stone	check at every 6 months up to 3 years postoperatively
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
Change of Albumin	check at every visit up to 3 years postoperatively
Operative mortality	mortality for 90 days
Change of Protein	check at every visit up to 3 years postoperatively
Relapse-free survival	3 years postoperatively
Overall survival	3 years postoperatively
Operative morbidity	30 days for early morbidity
Change of Hemoglobin	check at every visit up to 3 years postoperatively
QOL measurement (EORTC C30/STO22) (composite)	6 month, 1 year, 2 year, 3 year postoperatively
Gross and microscopic changes measured by gastroscopy (composite)	1 year, 2 year, 3 year postoperatively

Locations (5): Yonsei University Severance Hospital
🇰🇷
Seoul, Korea, Republic of
National Cacner Center
🇰🇷
Goyang-si, Korea, Republic of
Kyungpook National University Hospital
🇰🇷
Daegu, Jung-gu, Korea, Republic of
Department of Surgery, Seoul National University BUNDANG Hospital
🇰🇷
Seongnam, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of