Portal vein thrombosis
Conditions
Interventions
Group 1: Stratum A includes patients undergoing ISGPS type I–III portal and/or superior mesenteric vein reconstruction during pancreatic resection. Following preoperative screening, patient informatio
Sponsors
Univesitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Planned pancreatic resection — Whipple procedure/pancreatoduodenectomy/total pancreatectomy — with suspected PV/SMV involvement. Intraoperative PV/SMV resection and reconstruction due to suspected or confirmed malignant disease requiring portal/mesenteric venous reconstruction according to the ISGPS classification, types I–IV. - Capacity to provide informed consent, with patient information provided in German. - Written informed consent obtained prior to surgery, including consent for intraoperative randomization according to ISGPS type.
Exclusion criteria
Exclusion criteria: - Pre-existing preoperative portal vein thrombosis confirmed by CT imaging. - High risk of bleeding, e.g. platelet count 1.8 without a correctable cause, or non-correctable impairment of primary haemostasis. - Impaired renal function with eGFR <30 mL/min/1.73 m², resulting in contraindication to or insufficient controllability of LMWH/fondaparinux therapy. - Patients of childbearing potential using oral contraceptives. - Existing pregnancy. - Pre-existing therapeutic anticoagulation for another mandatory indication that cannot be modified in accordance with the study protocol, e.g. mechanical heart valve or recent extensive pulmonary embolism within the past 6 months. - Concurrent participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint “early thromboembolic events = 30 days”, defined as at least one of the following centrally adjudicated events: a) Imaging-confirmed PV/SMV graft thrombosis/occlusion, either partial or complete.* b) Clinically relevant and diagnostically confirmed deep vein thrombosis (DVT; proximal or distal) or pulmonary embolism (PE; segmental or proximal). c) Emergency re-intervention due to thrombotic complications of the venous reconstruction, including surgical, radiological interventional/angiographic, or endovascular procedures. *According to the institution’s internal clinical standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety/bleeding: Postpancreatectomy haemorrhage (PPH) according to ISGPS grade B/C up to day 30; transfusion requirements, including packed red blood cells, plasma, and platelet concentrates. • Severe complications: Clavien–Dindo grade = IIIb complications up to date 30; 30-day mortality. • Organ function: Maximum values and longitudinal courses of AST, ALT, ?-GT, alkaline phosphatase, and bilirubin; occurrence of post-hepatectomy liver failure based on ISGLS criteria. • Re-interventions: Rate of reoperations, angiographic and endovascular procedures; intensive care unit length of stay, overall hospital length of stay, and 30-day readmission. | — |
Countries
Germany
Contacts
Public ContactAnna Nießen
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed