Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

Phase 4

Recruiting

• Conditions: Pancreas Cancer; Pancreas Neoplasm; Surgery; Thrombosis; Bleeding
• Interventions: Drug: enoxaparin/tinzaparin/dalteparin

• Registration Number: NCT05245877
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-18
• Study Start: 2022-08-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative thromboprophylaxis	enoxaparin/tinzaparin/dalteparin	Preoperatively initiated tromboprophylaxis

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism, number of patients	within 30 days from pancreatic resection	Number of patients that have venous thromboembolism, which include any of the following: 1) symptomatic deep venous thromboembolism (including all deep veins e.g. all extremities, portal-, and superior mesenteric vein) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparotomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism.

Secondary Outcome Measures

Name	Time	Method
Postpancreatectomy hemorrhage (PPH)	within 30 days from pancreatic resection	Postpancreatectomy hemorrhage (PPH), any grade in ISGPS classification for postpancreatectomy hemorrhage, number of patients
Comprehensive Complication Index - score	within 30 days from pancreatic resection	Comprehensive Complication Index - score
Length of postoperative hospital stay,	within 30 days from pancreatic resection	Length of postoperative hospital stay, days, within 30 days from pancreas resection including hospital stay due to readmission(s)
Transfused red blood cells	during and within 30 days from pancreas resection	Total amount of transfused red blood cells, units, during and within 30 days from pancreas resection
Post-operative hemoglobin below 70 g/l	during and within 30 days from pancreas resection	Number of patients with post-operative hemoglobin below 70 g/l

Trial Locations

Locations (5)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Canada

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Oslo University Hospital; 🇳🇴 Oslo, Norway