Advanced distal gastric cancer with outflow tract obstruction ( clinical stage T4bN + M0 / T3-4N + M1, stage IV )
Conditions
Interventions
CGJ group : received traditional gastrojejunostomy:Traditional gastrojejunostomy
SPGJ group : received separated gastrojejunostomy:Separated gastric jejunum anastomosis
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient and their family fully understand this study and voluntarily sign the informed consent form; 2. Age 18-75 years (including 18 and 75 years old); 3. Pathologically confirmed distal gastric cancer that is locally unresectable, has distant metastasis, or peritoneal metastasis and cannot undergo radical surgery (cT4bN M0/T3-4N M1, stage IV); 4. Accompanied by gastrointestinal obstruction (confirmed by upper gastrointestinal imaging or gastroscopy showing gastric retention, and GOOSS score =1.5×10^9/L, white blood cell count >=4.0×10^9/L; b) platelets >=100×10^9/L; c) hemoglobin >=60 g/L; d) total bilirubin (TBIL) =50 mL/min); g) left ventricular ejection fraction (LVEF) >=50%; h) QT interval corrected by Fridericia's formula (QTcF) <470 ms; i) INR <=1.5×ULN, APTT <=1.5×ULN. 9. Women of childbearing potential must use effective contraception; 10. No other surgical contraindications; 11. Good compliance and willingness to cooperate with follow-up.
Exclusion criteria
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 ) 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 ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the incidence of delayed gastric emptying between SPGJ and CGJ in the treatment of advanced gastric cancer outflow tract obstruction.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the postoperative complications of SPGJ and CGJ in the treatment of advanced gastric cancer outflow tract obstruction.; | — |
Countries
China
Contacts
Public ContactYuzhou Qin
Guangxi Medical University Cancer Hospital
Outcome results
None listed