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

JRCT ID: jRCT1042180138

Registered date:28/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 06/09/2016
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Arm A) Esophagojejunostomy using a circular stapler.
Arm B) Esophagojejunostomy using a linear stapler.

Outcome(s)

• Primary Outcome: Postgastrectomy syndrome at 12 months after operation (Complaint will be evaluated by EORTC QLQ-STO22)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Terashima Masanori