Gastric cancer Gastric cancer
Conditions
Interventions
Arm A) Esophagojejunostomy using a circular stapler.
Arm B) Esophagojejunostomy using a linear stapler.
D000713
Sponsors
Terashima Masanori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven adenocarcinoma of the stomach 2. A total gastrectomy with curative intention is planned for gastric cancer located in the upper third of the stomach. 3. cStage I-III 4. No esophageal invasion >3 cm 5. No gastric stump cancer 6. 20-year-old or older 7. Eastern cooperative oncology group performance status is 0 or 1. 8. No previous chemotherapy or radiation therapy, including those for other cancers 9. Body mass index is less than 30. 10. Fulfills all of the following conditions WBC>3,000/mm3 Plt>100,000/mm3 AST<100IU/L ALT<100IU/L T.Bil<2.0g.dl Cre<1.5mg/dl 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Other active cancer 2. Active infectious disease 3. Possibly pregnant, or breast feeding woman 4. Psychiatric disorder 5. Receiving steroids 6. Acute myocardial infarction within 6 months or unstable angina 7. Uncontrolled hypertension 8. Uncontrolled diabetes mellitus and receiving insulin treatment 9. Pulmonary disease requiring continuous oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postgastrectomy syndrome at 12 months after operation (Complaint will be evaluated by EORTC QLQ-STO22) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) EORTC QLQ-C30, EORTC QLQ-STO22 score (excepting the items of eating restriction), 2) incidence of adverse events , 3) operation time (time for anastomosis), 4) amount of bleeding during surgery, 5) body weight loss after surgery, 6) trend of serum albumin level after surgery, 7) completion rate of adjuvant chemotherapy, 8) overall survival | — |
Contacts
Public ContactKenichiro Furukawa
Shizuoka Cancer Center
Outcome results
None listed