duodenal tumor
Conditions
Interventions
Laparoscopic-endoscopic cooperative surgery
Sponsors
Gastrointestinal Surgery, Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, patients must fulfill the following requirements preoperatively: 1) duodenal tumor is 5 cm or smaller and difficult having en-bloc resection by endoscopic mucosal resection. 2) Aged 20 to 80 year 3) PS (ECOG)0 or 1 4) provided written informed consent
Exclusion criteria
Exclusion criteria: 1) no history of gastrointestinal surgery except appendectomy due to appendicitis. 2) no history of chemotherapy or radiotherapy. 3) all laboratory data must fulfill the following requirements within 56 days prior to trial registration. 1. white blood cell count; 3,000/mm3 or more 2. blood platelet count; 100,000/mm3 or more 3. Aspartate Aminotransferase; 100 IU/L or lower 4. Alanine aminotransferas; 100 IU/L or lower 5. total bilirubin; 2.0 mg/dL or lower 6. creatinine; 1.5 mg/dL or lower 4) without informed consent 5) patients who were judged inadequate by clinical trial principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of anastomotic leakage of the duodenum within one month after operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of adverse event (Clavien-Dindo classification, GradeII and higher) and operation related death within one month after opeartion, and proportion of conversion to open surgery | — |
Countries
Japan
Contacts
Public ContactShingo Kanaji
Kobe University Gastrointestinal Surgery
Outcome results
None listed