C25.0
Conditions
Interventions
Group 1: Experimental arm: Minimal invasive spleen presevering left side pancreatic resection
Group 2: Standard arm: Minimally invasive splenectomy with left pancreatic resection
Sponsors
Uniklinik RWTH Aachen, Klinik für Allgemein-, Viszeral-, Kinder- & Transplantationschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Suspected or confirmed diagnosis of a primarily resectable pancreatic carcinoma in the distal corpus to cauda of the pancreas for primary resection The tumor appears to be resectable for both the spleen-preserving and the spleen-resecting approach Non-pathologically enlarged lymph nodes in the splenic hilus (lymph node station 10) in preoperative imaging No suspicion of tumor infiltration or direct contact with the spleen on preoperative imaging Ability to consent, understand and adhere to the study protocol, study visits and treatment plan Written informed consent from the patient prior to study participation
Exclusion criteria
Exclusion criteria: Borderline or locally advanced pancreatic carcinoma without the possibility of primary resection Suspected macroscopic infiltration of the splenic artery and/or splenic vein on preoperative imaging Suspected tumor infiltration or direct contact with the spleen on preoperative imaging Pathologically enlarged lymph nodes in the splenic hilus (lymph node station 10) on preoperative imaging Evidence of distant metastases CA19-9 values of >1,000 U/mL Patients with an Eastern Cooperative Oncology Group (ECOG) performance status =2 Current or planned pregnancy during the study period, and unwillingness or inability to use highly effective contraceptive methods. Inability to consent, understand and/or adhere to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity and mortality (Clavien-Dindo classification grade 0-5) Comprehensive Complication Index (0-100) Postoperative hospitalization (date of surgery/discharge) Postoperative intensive care unit (date of surgery/transfer to normal ward) Pancreatic fistulas (yes/no) Postoperative bleeding after pancreatic resection (yes/no) Lymphatic fistulas (yes/no) Gastric emptying disorder (yes/no) Conversion rate (yes/no) Number of interventional drains postoperatively Intra-abdominal behavior Intraoperative blood loss and duration of surgery Number of lymph nodes removed (absolute number) Detection of lymph node metastases LK station no. 10 Overall survival after 2 years (OS) (index operation/death) Disease-free survival after 2 years (DFS) (index operation/recurrence of underlying disease) Start and type of adjuvant chemotherapy Unscheduled inpatient readmission Quality of life (QoL) preoperatively, within 48 hours before discharge, and after 3, 6, 9, 12 and 24 months using the QLQ-C-30 and QLQ-PAN-26 questionnaires. | — |
Countries
Germany
Contacts
Public ContactGeorg Wiltberger
Uniklinik RWTH Aachen, Klinik für Allgemein-, Viszeral-, Kinder- & Transplantationschirurgie
Outcome results
None listed