A randomized phase II study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy

Phase 2

Recruiting

• Conditions: Gastric cancer; D013274

• Registration Number: JPRN-jRCT1042180138
• Lead Sponsor: Terashima Masanori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified