Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

Summary

Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. There are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.

Interventions

• enoxaparin/tinzaparin/dalteparin · DRUG

  Patients randomized to the preoperative thromboprophylaxis will have their thromboprophylaxis initiated approximately 2-14 hours prior to the planned pancreatic surgery skin incision (depending on the center's current practice and logistics). Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function according to the local standard of care. A center may reduce the dose 25-50% if the dose is given very close to the skin incision (i.e. at the morning of the operation instead of the evening before the operation).

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

All patients undergoing either

1. pancreaticoduodenectomy or total pancreatectomy (for any indication) or
2. distal pancreatectomy for suspicion of cancer

Exclusion Criteria:

1. Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
2. Emergency operation (e.g. for trauma, infection or pancreatitis)
3. Age \< 18 years
4. Allergy or other contraindication to planned low-molecular weight heparin
5. Inability to give written informed consent
6. Pancreatic resection not performed (removed from analyses after randomization)

Sites (5)

• Sunnybrook Health Sciences Centre, Toronto, Canada · RECRUITING
• Helsinki University Hospital, Helsinki, Finland · RECRUITING
• Oulu University Hospital, Oulu, Finland · RECRUITING
• Tampere University Hospital, Tampere, Finland · RECRUITING
• Oslo University Hospital, Oslo, Norway · RECRUITING