Gastric Neoplasm
Conditions
Keywords
stomach neoplasms, lymph node resection, cardia, thoracotomy
Brief summary
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer
Detailed description
For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.
Interventions
PROCEDURESurgery: abdominal and transhiatal approach
PROCEDURESurgery: left thoraco-abdominal approach
Sponsors
Ministry of Health, Labour and Welfare, Japan
Japan Clinical Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
1. histologically proven adenocarcinoma 2. 75 years old or younger 3. forced expiratory volume in one second ≥ 50 % 4. arterial oxygen pressure in room air ≥ 70 mmHg 5. clinically T2/T3/T4 with ≤3 cm esophageal invasion 6. written consent
Exclusion criteria
1. Carcinoma in the remnant stomach 2. Borrmann type 4 (linitis plastica) 3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma 4. history of left thoracotomy, or left pleural adhesion 5. past history of myocardial infarction or positive results of exercise ECG 6. liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse-free survival | — |
| operative morbidity and mortality | — |
| quality of life | — |
Countries
Japan
Outcome results
None listed