Malignant Gastric Outlet Obstruction Study With Stomach Partitioning (GO-PART) (GO-PART)

August 7, 2026 updated by: Sangho Jeong, Gyeongsang National University Hospital

Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (GO-PART Study, KLASS 16)

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:

  1. Does SPGJ significantly decrease DGE compared with CGJ?
  2. Does SPGJ enable faster food tolerance, shorter hospital stay, and earlier chemotherapy? Researchers will compare two arms - SPGJ and CGJ - to determine differences in postoperative gastric emptying, hospital course, complications, and survival outcomes.

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

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sang-Ho Jeong, MD, PhD
  • Phone Number: +82-10-5060-32 +82-55-214-3774
  • Email: shjeong@gnu.ac.kr

Study Contact Backup

Study Locations

  • South Korea
    • Gyeongsangnam-do
      • Changwon, Gyeongsangnam-do, South Korea, 51472
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CGJ Arm
Conventional Gastrojejunostomy group
Procedure: Conventional Gastrojejunostomy
Traditional Laparoscopic Gastrojejunostomy
Experimental: SPGJ Arm
Stomach-Partitioning Gastrojejunostomy group
Procedure: Conventional Gastrojejunostomy
Traditional Laparoscopic Gastrojejunostomy
Procedure: Stomach-Partitioning
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the Incidence of Delayed Gastric Emptying (DGE)
Time Frame: 30 days post-surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Outlet Obstruction Score at Postoperative Day 7.
Time Frame: Postoperative Day 7.
0: No oral intake (unable to eat or drink anything), 1: Liquids only, 2: Soft foods/half fluids only, 3: Almost normal diet, 4: Normal diet
Postoperative Day 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Collaborators

Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

August 1, 2026

First Submitted That Met QC Criteria

August 1, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stomach partitioning-KLASS16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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