The goal of this clinical trial is to evaluate whether stomach-partitioning gastrojejunostomy (SPGJ) more effectively reduces postoperative delayed gastric emptying (DGE) compared to conventional gastrojejunostomy (CGJ) in patients with unresectable stage IV gastric cancer accompanied by malignant gastric outlet obstruction (MGOO). This multicenter randomized trial aims to establish a new surgical standard that enhances recovery and quality of life in advanced gastric cancer.
The main questions are:
Participants Eligible participants are adults aged 20-85 years with histologically proven unresectable gastric adenocarcinoma limited to the lower third of the stomach and endoscopic or radiologic evidence of obstruction. Patients with total bowel obstruction, middle-third tumor extension, emergency conditions, or severe malnutrition (albumin < 2.5 g/L) are excluded.
Interventions
All operations follow standardized training videos and pretrial workshops to ensure consistency across 32 Korean university hospitals.
Study Design This is a prospective, randomized controlled multicenter trial (KLASS 16). After intraoperative diagnostic laparoscopy confirms eligibility, participants are randomized by a secure web-based block system stratified by hospital. A total of 144 patients (72 per arm) will be enrolled, ensuring 90% statistical power based on expected DGE rates (CGJ 34.6% vs SPGJ 3.8%).
Endpoints
Data Collection and Analysis Data will include postoperative nutrition recovery, complication grades, and survival follow-up. Analyses will utilize Chi square or Fisher's exact test for DGE rates and Kaplan-Meier with log rank testing for survival. Logistic regression will identify DGE risk factors.
Duration Total 3 years: 6 months preparation, 1 year enrollment, 1 year follow up, and 6 months for data analysis and reporting.
Expected Outcomes SPGJ is expected to reduce DGE by > 70%, shorten hospital stay by ~3 days, and enable earlier chemotherapy, thereby improving palliative care outcomes and overall patient quality of life. The KLASS 16 trial will provide the first multicenter, Level I evidence to determine whether SPGJ should replace CGJ as the standard palliative procedure for MGOO.
Inclusion Criteria:
Histologically confirmed gastric adenocarcinoma with Gastric Outlet Obstruction (GOO) that is unresectable for cure (e.g., surrounding tissue invasion, localized peritoneal metastasis, distant metastasis)
Tumor location confined to the lower one-third (Low body 1/3) of the stomach â‘¢ Age between 20 and 85 years
Exclusion Criteria:
Patients with bowel obstruction due to extensive peritoneal metastasis (P3)
shjeong@gnu.ac.kr
Conventional Gastrojejunostomy group
Stomach-Partitioning Gastrojejunostomy group
goodgsdr@gmail.com+82+10-9355-0510
Comparison of Partial Stomach-Partitioning and Conventional Gastrojejunostomy for the Treatment of Gastric Outlet Obstruction in Advanced Gastric Cancer
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
Comparison of Laparoscopic Pylorus Preserving Gastrectomy Versus Laparoscopic Distal Gastrectomy
Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
EUS-guided Versus Laparoscopic Gastrojejunostomy for Malignant Gastric Outlet Obstruction