Two Stomach Bypass Operations for Blocked Stomach Outlet in Advanced Stomach Cancer

Trial details

Who runs it

Guangxi Medical University

Trial code

NCT07561073

Record updated

15 October 2026

Original description

Gastric outlet obstruction (GOO) complicates locally advanced or metastatic gastric cancer and severely impairs oral intake, nutritional status, and quality of life. Conventional gastrojejunostomy (CGJ) effectively relieves the obstruction but is associated with a high incidence of delayed gastric emptying (DGE), which delays the resumption of oral intake and the initiation of systemic anticancer therapy. Stomach-partitioning gastrojejunostomy (SPGJ) isolates the tumour-bearing distal stomach from the alimentary tract and has been suggested, in retrospective studies, to reduce the incidence of DGE. However, the only randomized comparison reported to date was a small monocentric trial that assessed oral intake acceptance rather than gastric emptying. The comparative effect of SPGJ and CGJ on delayed gastric emptying therefore remains untested in a randomized setting. This multicenter, randomized, open-label, blinded-outcome-assessment trial will randomly assign 80 participants with unresectable distal gastric adenocarcinoma complicated by GOO, in a 1:1 ratio, to undergo either SPGJ or CGJ. The primary endpoint is the incidence of postoperative DGE within 30 days after surgery.Read full original descriptionShow less

A Multicenter Randomized Controlled Trial Comparing the Safety and Efficacy of Stomach-Partitioning Gastrojejunostomy (SPGJ) Versus Conventional Gastrojejunostomy (CGJ) for Advanced Gastric Cancer-Associated Gastric Outlet Obstruction

Gastric outlet obstruction (GOO) complicates locally advanced or metastatic gastric cancer and severely impairs oral intake, nutritional status, and quality of life. Conventional gastrojejunostomy (CGJ) effectively relieves the obstruction but is associated with a high incidence of delayed gastric emptying (DGE), which delays the resumption of oral intake and the initiation of systemic anticancer therapy. Stomach-partitioning gastrojejunostomy (SPGJ) isolates the tumour-bearing distal stomach from the alimentary tract and has been suggested, in retrospective studies, to reduce the incidence of DGE. However, the only randomized comparison reported to date was a small monocentric trial that assessed oral intake acceptance rather than gastric emptying. The comparative effect of SPGJ and CGJ on delayed gastric emptying therefore remains untested in a randomized setting. This multicenter, randomized, open-label, blinded-outcome-assessment trial will randomly assign 80 participants with unresectable distal gastric adenocarcinoma complicated by GOO, in a 1:1 ratio, to undergo either SPGJ or CGJ. The primary endpoint is the incidence of postoperative DGE within 30 days after surgery.

Inclusion: Patients and their family members must be fully informed of the study procedures and voluntarily provide written informed consent prior to enrollment; Age 18-75 years (inclusive); Pathologically confirmed distal gastric adenocarcinoma deemed unresectable due to locally advanced disease, distant metastasis, or peritoneal dissemination (cT4bM0 or T3-4M1, regardless of the clinical lymph node status, stage IV), and therefore unsuitable for curative resection; Presence of gastrointestinal obstruction confirmed by upper gastrointestinal contrast radiography or endoscopy, manifested as gastric retention with a Gastric Outlet Obstruction Scoring System (GOOSS) score <= 1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 without deterioration within 7 days prior to enrollment; American Society of Anesthesiologists (ASA) physical status classification I-III; No prior antitumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.

Exclusion: Active autoimmune disease within 4 weeks prior to enrollment or a documented history of autoimmune disease; Prior allogeneic bone marrow transplantation or solid organ transplantation; Pregnant women (positive pregnancy test prior to treatment initiation) or lactating women; History of another malignancy within 5 years prior to enrollment, with the exception of adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix following curative therapy; Active or uncontrolled severe infection, defined as grade >= 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0; Known human immunodeficiency virus (HIV) infection, or a history of clinically significant liver disease, including viral hepatitis: known hepatitis B virus (HBV) carriers must be excluded if active HBV infection is present, defined as HBV DNA positivity (> 1 x 10\^4 copies/mL or > 2000 IU/mL); known hepatitis C virus (HCV) infection with positive HCV RNA (> 1 x 10\^3 copies/mL); Any condition that, in the opinion of the investigator, makes the patient inappropriate for inclusion in this trial; Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe or unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure classified as New York Heart Association (NYHA) functional class > II; ventricular arrhythmias requiring pharmacologic treatment; or left ventricular ejection fraction (LVEF) < 50%; Any other disease, clinically significant metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the judgment of the investigator, may render the patient unsuitable for study participation (e.g., uncontrolled seizure disorder requiring treatment), interfere with the interpretation of study results, or place the patient at undue risk; Inability or unwillingness to comply with the study protocol or required study procedures.

ClinicalTrials.gov NCT07561073