Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (KLASS 16)
1 other identifier
interventional
144
1 country
1
Brief Summary
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:
- CGJ arm: Standard laparoscopic gastrojejunostomy using a 60 mm stapler without partitioning.
- SPGJ arm: Laparoscopic transverse gastric partitioning 5 cm proximal to the tumor with a 2 cm bridge at the lesser curvature, followed by stapled gastrojejunostomy. 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
- Primary endpoint: Incidence of DGE within 30 days (ISGPS criteria).
- Secondary endpoints: Day of oral tolerance (GOO score ≥ 2), hospital stay, Clavien-Dindo ≥ II complications, mechanical obstruction recurrence, 6 and 12 month overall survival, and quality of life. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
August 6, 2026
August 1, 2026
2 years
August 1, 2026
August 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the Incidence of Delayed Gastric Emptying (DGE)
DGE occurring within 30 days post-surgery between the Conventional Gastrojejunostomy (CGJ) group and the Stomach-Partitioning Gastrojejunostomy (SPGJ) group
30 days post-surgery
Secondary Outcomes (1)
GOO Score at Postoperative Day 7.
Postoperative Day 7.
Study Arms (2)
CGJ Arm
ACTIVE COMPARATORConventional Gastrojejunostomy group
SPGJ Arm
EXPERIMENTALStomach-Partitioning Gastrojejunostomy group
Interventions
Laparoscopic stomach partitioning (Transversely divide the stomach 5 cm or more proximal to the tumor mass, leaving an approximately 2 cm uncut space at the lesser curvature (LC) side)
Eligibility Criteria
You may qualify if:
- 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 ③ Age between 20 and 85 years
- ECOG Performance Status ≤ 2 ⑤ ASA score Class I to III ⑥ Endoscopic or radiologic evidence of obstructive GOO
You may not qualify if:
- Patients with bowel obstruction due to extensive peritoneal metastasis (P3)
- Tumor extension beyond the lower one-third into the middle one-third of the stomach, making partitioning difficult ③ Patients requiring emergency surgery for perforation or hemorrhage ④ Severe malnutrition (serum albumin \< 2.5} g/L) ⑤ Patients currently undergoing pre-operative chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gyeongsang National University Hospitallead
- Medtroniccollaborator
Study Sites (1)
Gyeongsang National University Changwon hospital
Changwon, Gyeongsangnam-do, 51472, South Korea
Related Publications (1)
Hai NV, Thong DQ, Dat TQ, Nguyen DT, Quoc HLM, Minh TA, Anh NVT, Vuong NL, Trung TT, Bac NH, Long VD. Stomach-partitioning versus conventional gastrojejunostomy for unresectable gastric cancer with gastric outlet obstruction: A propensity score matched cohort study. Am J Surg. 2024 Feb;228:206-212. doi: 10.1016/j.amjsurg.2023.09.044. Epub 2023 Oct 1.
PMID: 37827868RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2026
First Posted
August 6, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2030
Last Updated
August 6, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Sharing will commence no later than 6 months after the publication of the primary manuscript in an ICMJE-member journal. The data will remain accessible for a minimum period of 5 years from the start date, with a possibility for extension upon re-evaluation by the study team
- Access Criteria
- Access will be granted to all researchers submitting a scientifically and methodologically sound proposal for secondary research. Materials provided will include: De-identified Individual Participant Data (IPD), the Study Protocol, the Statistical Analysis Plan (SAP), the Data Dictionary, and the Analytic Code used for the primary publication. Access Mechanism: Researchers must submit a formal proposal, proof of Institutional Review Board (IRB) approval, and sign a Data Use Agreement (DUA) to the KLASS 16 Central Study Team (Principal Investigator). Data access will be provided via a secure, controlled-access platform following approval. The requestor may be subject to a nominal data transfer fee.