Partial stomach-partitioning versus conventional gastrojejunostomy to relieve gastric outlet obstruction from advanced stomach cancer.

A Multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Partial Stomach-Partitioning Gastrojejunostomy Versus Conventional Gastrojejunostomy for the Treatment of Gastric Outlet Obstruction in Advanced Gastric Cancer

This test compares whether partial stomach-partitioning or conventional gastrojejunostomy better relieves blockage and restores eating in adults with advanced distal gastric cancer causing gastric outlet obstruction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangxi Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT07561073 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, multi-center study enrolling adults with advanced distal gastric cancer and confirmed gastric outlet obstruction who are randomized 1:1 to partial stomach-partitioning gastrojejunostomy (SPGJ) or conventional gastrojejunostomy (CGJ). Primary outcomes include delayed gastric emptying classification and the Gastric Outlet Obstruction Scoring System (GOOSS) for oral intake, with imaging experts, patient-reported outcome collectors, and statisticians blinded to treatment assignment. The protocol covers screening, the surgical intervention, postoperative medical treatment, and scheduled follow-up to monitor complications, bleeding, anastomotic invasion, and quality of life. The trial aims to produce higher-quality prospective evidence to determine which surgical approach leads to faster return to oral feeding and fewer postoperative problems.

Who should consider this trial

Good fit: Adults 18–75 years old with distal advanced gastric cancer (locally unresectable or metastatic) and confirmed gastric outlet obstruction (GOOSS ≤ 1), an ECOG score of 0–2, acceptable organ function, no prior anti-tumor therapy, and deemed unfit for radical surgery are eligible.

Not a fit: Patients who are candidates for curative resection, have only mild or no obstruction (GOOSS > 1), have severe organ dysfunction or prohibitive surgical risk, or have received prior anti-tumor therapy are unlikely to benefit from this surgical comparison.

Why it matters

Potential benefit: If successful, the preferred procedure could enable faster return to oral feeding, fewer bleeding or anastomotic complications, and improved quality of life for patients with obstructive advanced gastric cancer.

How similar studies have performed: Previous small or retrospective studies have suggested partitioned gastrojejunostomy may reduce delayed gastric emptying and tumor-related complications, but evidence remains limited and inconclusive.

Eligibility criteria

Inclusion Criteria:

1. Patients and their families were fully aware of this study and voluntarily signed informed consent ;
2. Age 18-75 years old ( including 18 and 75 years old ) ;
3. Distal gastric cancer ( cT4bN + M0 / T3-4N + M1, stage IV ) with locally unresectable, distant metastasis or peritoneal metastasis confirmed by pathology and unable to undergo radical surgery ;
4. Complicated with digestive tract obstruction ( gastric retention confirmed by upper gastrointestinal radiography or gastroscopy, and GOOSS score ≤ 1 ) ; the ECOG score was 0-2 points, and there was no deterioration within 7 days ;

6.ASA score I-III ; 7.No previous anti-tumor therapy ( such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. ) :

The functions of important organs meet the following requirements :

( a ) absolute neutrophil count ≥ 1.5 × 109 / L, white blood cell count ≥ 4.0 × 109/L; b ) Platelet ≥ 100 × 109 / L ; c ) Hemoglobin ≥ 60g / L ; d ) TBIL ≤ 1.5 times ULN ; e ) ALT and AST ≤ 2.5 times ULN ; f ) urea / urea nitrogen ( BUN ) and creatinine ( Cr ) ≤ 1.5 × ULN ( and creatinine clearance rate ( CCr ) ≥ 50mL / min ) ; g ) Left ventricular ejection fraction ( LVEF ) ≥ 50 % ; the corrected QT interval ( QTcF ) by Fridericia method was less than 470 ms. i ) INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN. 9. women of childbearing age need to take effective contraceptive measures ; 10.No other surgical contraindications ; 11.good compliance, with follow-up.

Exclusion Criteria:

1. Unable to comply with the research program or research procedures ;
2. Patients with other malignant tumors within 5 years before enrollment, except for basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ;
3. Patients with active autoimmune diseases or a history of autoimmune diseases within 4 weeks before enrollment ;
4. Previously received allogeneic bone marrow transplantation or organ transplantation ;
5. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment ; congestive heart failure New York Heart Association ( NYHA ) grade \> 2 ; ventricular arrhythmia requiring drug treatment ; lVEF ( left ventricular ejection fraction ) \< 50 % ;
6. Active or uncontrolled severe infection ( ≥ CTCAE V5.0 grade 2 infection ) ;
7. Known human immunodeficiency virus ( HIV ) infection. Patients with known clinical history of liver disease, including viral hepatitis \[ known as hepatitis B virus ( HBV ) carriers must be excluded from active HBV infection, that is, HBV DNA positive ( \> 1 × 104 copies / mL or \> 2000 IU / ml ) ; it is known that hepatitis C virus infection ( HCV ) and HCV RNA positive ( \> 1 × 103 copies / mL ) ;
8. pregnant ( pregnancy test positive before medication ) or breastfeeding women ;
9. Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of the researchers, it is reasonable to suspect that the patient has a state that is not suitable for enrollment ( such as having seizures and requiring treatment ), or will affect the interpretation of the results of the study, or put the patient at high risk ; the researchers considered that the patients were not suitable for inclusion in this study.

Where this trial is running

Nanning, Guangxi

• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)

Study contacts

• Study coordinator: Yuzhou Qin

Conditions Gastric Cancer; Gastric cancer; conventional gastrojejunostomy; Partial Stomach-Partitioning Gastrojejunostomy