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

A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy - Laparoscopic esophagojejunostomy with linear or circular stapler

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023464

Enrollment

Registered

2016-08-03

Start date

2016-08-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Esophagojejunostomy is performed using a linear stapler. Esophagojejunostomy is performed using a circular stapler.

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. Over 20 years old 7. Eastern clinical 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)	—

Countries

Japan

Contacts

Public ContactYusuke Koseki

Shizuoka Cancer Center Gastric Surgery

y.koseki@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026