Stomach NeoplasmsGO-PARTNCT07749326
Malignant Gastric Outlet Obstruction Study With Stomach Partitioning (GO-PART)
A study testing Conventional Gastrojejunostomy and Stomach-Partitioning in people with Stomach Neoplasms and Gastric Outlet Obstruction, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stomach Neoplasms, Gastric Outlet Obstruction
- What is being tested?
- Conventional Gastrojejunostomy and Stomach-Partitioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gyeongsang National University Changwon hospital
Changwon, Gyeongsangnam-do, 51472
Sangho Jeong, +82552143771, shjeong@gnu.ac.kr
About this study
Official title: 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:
Read more
- Does SPGJ significantly decrease DGE compared with CGJ?
- 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.
- Conditions
- Stomach Neoplasms, Gastric Outlet Obstruction
- Being tested
- Conventional Gastrojejunostomy, Stomach-Partitioning
- Keywords
- stomach neoplasm, gastric outlet obstruction, palliative surgery
- Medical subject headings
- Stomach Neoplasms, Gastric Outlet Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional GastrojejunostomyProcedure or surgery
Traditional Laparoscopic Gastrojejunostomy
Stomach-PartitioningProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| CGJ Arm | Active comparator | Conventional Gastrojejunostomy group Receives: Procedure: Conventional Gastrojejunostomy |
| SPGJ Arm | Experimental | Stomach-Partitioning Gastrojejunostomy group Receives: Procedure: Conventional Gastrojejunostomy; Procedure: Stomach-Partitioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post-surgery
Secondary outcomes (1)
Gastric Outlet Obstruction Score at 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
Measured: Postoperative Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Sangho Jeong, Gyeongsang National University Changwon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749326
- Sponsor's protocol ID
- Stomach partitioning-KLASS16
- Acronym
- GO-PART
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37827868
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (GO-PART Study, KLASS 16)
- ClinicalTrials.gov ID
- NCT07749326
- Acronym / sponsor ID
- GO-PART / Stomach partitioning-KLASS16
- Conditions
- Stomach Neoplasms, Gastric Outlet Obstruction
- Keywords
- stomach neoplasm, gastric outlet obstruction, palliative surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does SPGJ significantly decrease DGE compared with CGJ?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGJ Arm | Active comparator | Procedure: Conventional GastrojejunostomyConventional Gastrojejunostomy group |
| SPGJ Arm | Experimental | Procedure: Conventional Gastrojejunostomy, Procedure: Stomach-PartitioningStomach-Partitioning Gastrojejunostomy group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed gastric adenocarcinoma with Gastric Outlet Obstruction (GOO) that is unresectable for cure (e.g., surrounding tissue invasion, localized peritoneal metastasis, distant metastasis)
Key exclusion criteria (2 listed)
- Patients with bowel obstruction due to extensive peritoneal metastasis (P3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional GastrojejunostomyTraditional Laparoscopic Gastrojejunostomy | Procedure or surgery | CGJ Arm, SPGJ Arm |
| Stomach-PartitioningLaparoscopic 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) | Procedure or surgery | SPGJ Arm |
Primary outcome
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
1 secondary outcome
Gastric Outlet Obstruction Score at Postoperative Day 7.
Time frame: Postoperative Day 7.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 37827868Hai 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Gastrojejunostomy and Stomach-Partitioning in people with Stomach Neoplasms and Gastric Outlet Obstruction, run by Gyeongsang National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang-Ho Jeong, MD, PhD (+82-55-214-3774 ext. +82-10-5060-32, shjeong@gnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Incidence of Delayed Gastric Emptying (DGE) (time frame: 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07749326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.