C25.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Suspected primary resectable pancreatic head carcinoma. - Eligible for both surgical procedures Patients =18 years of age at the time of signing the informed consent form. - Presence of written informed consent from the patient prior to initiation of study-specific procedures - Patient's ability to give informed consent for study participation
Exclusion criteria
Exclusion criteria: - Borderline or locally advanced pancreatic cancer. - Evidence of distant metastases - Patient who is institutionalized due to a court or administrative order - Patient eligible for only one of the two procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is the rate of R0 resection (dorsal margin) defined according to the German S-III guideline Pancreatic Cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include: - Morbidity (Clavien-Dindo classification grade 0-5) - Comprehensive Complication Index - Blood loss (ml) - In-hospital mortality (surgery date/discharge date; yes/no) - 90-day mortality (death from any cause; yes/no) - postoperative hospitalization (surgery date/discharge date) - resected lymph nodes (number of lymph nodes) - anastomotic insufficiencies (yes/no) - pancreatic fistulas (yes/no) - lymph fistula (yes/no) - Overall survival (2 years) - disease free survival | — |
Countries
Germany
Contacts
Uniklinik RWTH Aachen, Klinik für Allgemein-, Viszeral- & Transplantationschirurgie