Esophageal cancer
Conditions
Interventions
Visualisation of the fluorescence excited by indocyanine green in the gastric tube and remnant esophageal wall using a Stryker video processor with integrated light source and SPY PHI, and quantitativ
Sponsors
Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient has a histological diagnosis of esophageal squamous cell carcinoma. 2) The planned operative procedure is a right thoracic approach subtotal esophagectomy and gastric tube reconstruction. 3) The patient is at least 18 years of age on the date of registration. 4) Gender is not relevant. 5) PS is 0 or 1 according to ECOG criteria. 6) Latest laboratory values within 28 days prior to enrolment are all below. Neutrophil count > 1,500/mm3 Platelet count > 7.5 x 104 /mm3 Hemoglobin > 9.0 g/dL Creatinine: < 1.5 times upper limit of normal AST/ALT: < 3 times upper limit of normal Total bilirubin: normal Less than 1.5 times the upper limit (for Gilbert's syndrome: Less than 3.0 mg/dL) 7)The patient's free written consent to participate in this clinical study has been obtained.
Exclusion criteria
Exclusion criteria: 1) Has an allergy to iodine or indocyanine green. 2) Have active systemic infections. 3) Requires treatment with systemic corticosteroids (prednisone equivalent >10 mg/day: inhaled and topical steroids and hormone replacement therapy are acceptable) or other immunosuppressive agents. 4) Planned two-stage surgery. 5) The patient is unwilling to use contraception and is pregnant or lactating. 6) Patients with dementia or psychiatric disorders requiring treatment that make it difficult to obtain their consent. 7) Other patients who are deemed inappropriate by the person in charge of this clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of anastomotic leakage | — |
Countries
Japan
Contacts
Public ContactHironobu Goto
Kobe University Hospital Division of Gastrointestinal Surgery
Outcome results
None listed