Risk of Bleeding During ERCP
Post-sphincterotomy bleeding is the most common hemorrhagic complication of ERCP, occurring in 1.1-2.1% of procedures, with the highest risk when biliary sphincterotomy is performed in patients on anticoagulation, those with coagulopathy (platelet count <50×10⁹/L), or when intraprocedural bleeding is observed. 1
Baseline Bleeding Risk
The overall bleeding risk varies significantly based on the specific ERCP intervention performed:
- Diagnostic ERCP without sphincterotomy: Considered low-risk for bleeding 1
- ERCP with biliary sphincterotomy: 1.1-2.1% bleeding rate in general populations 1
- ERCP in cirrhotic patients: 2.1% bleeding rate (vs 1.2% in non-cirrhotic controls) 1
- Severe/clinically significant hemorrhage: 0.1-2% of sphincterotomies 2
Bleeding can manifest as immediate (intraprocedural) or delayed, occurring up to several weeks post-procedure, with delayed bleeding being more common in anticoagulated patients 2, 3.
High-Risk Patient Factors
The ESGE guideline identifies patients at increased risk for post-sphincterotomy hemorrhage when at least one of the following is present: 1
- Anticoagulant intake (warfarin, DOACs, or heparin)
- Platelet count <50×10⁹/L
- Intraprocedural bleeding observed during the procedure
- Low endoscopist case volume/experience
- Active cholangitis 2
Additional risk factors from multivariate analyses include:
- Precut sphincterotomy technique: Significantly increases bleeding risk 4
- Obstruction of the papillary orifice 4
- Decompensated cirrhosis: Independent predictor of bleeding 1
- Therapeutic ERCP procedures (vs diagnostic only) 1
- Failed biliary stone clearance 1, 4
Anticoagulation-Specific Risks
Aspirin Monotherapy
Aspirin can be safely continued during ERCP with sphincterotomy. 1 A nationwide Japanese database and smaller observational studies demonstrate that sphincterotomy and balloon dilation can be performed safely in aspirin users, with no statistically significant increase in hemorrhage 1.
P2Y12 Inhibitors (Clopidogrel)
Limited data exist, but one small study of 95 patients on uninterrupted antithrombotic therapy (including 55 on aspirin plus clopidogrel) undergoing ERCP with minimal sphincterotomy showed an overall 4% bleeding rate 1. Withdrawal of P2Y12 inhibitors should be considered on an individual basis depending on thrombotic risk. 1
Warfarin and DOACs
These agents are typically withdrawn before ERCP with sphincterotomy given the high hemorrhage rate. 1 Post-procedure resumption should be delayed at least 48 hours, with consideration of extending to 72 hours if sphincterotomy was performed and hemostasis concerns exist 2.
Risk Mitigation Strategies
Procedural Modifications
Endoscopic papillary balloon dilation (EPBD) has a lower incidence of hemorrhage compared to sphincterotomy and should be considered as an alternative for biliary stone extraction, particularly in high-risk patients 2. One study showed sphincterotomy and balloon dilation can be performed with minimal bleeding risk when combined with careful technique 1.
Prophylactic Measures
The evidence for prophylactic endoscopic interventions is mixed:
- Prophylactic argon plasma coagulation: Conflicting data—effective in one retrospective study (n=82) but ineffective in an RCT (n=54) for preventing post-ampullectomy bleeding 1
- Prophylactic clipping: May reduce bleeding risk after polypectomy but data are limited for ERCP 5
- Submucosal injection prior to ampullectomy: Not effective in preventing bleeding and associated with higher tumor recurrence 1
Anticoagulation Management
For patients requiring ERCP with sphincterotomy: 2
- DOACs should be delayed at least 48 hours post-procedure, with extension to 72 hours if sphincterotomy performed and hemostasis concerns present
- Avoid heparin bridging—associated with significantly higher bleeding rates (12.0% vs 4.7% without bridging) 5
- Monitor for signs of bleeding for several days after restarting anticoagulation 2
Endoscopist Experience
Low endoscopist case volume is an independent risk factor for complications. 1 High-risk patients should be referred to experienced operators performing >150 ERCPs annually 6.
Common Pitfalls to Avoid
- Do not routinely correct INR or platelet counts prophylactically in cirrhotic patients—studies show no benefit and potential harm from prophylaxis 1
- Avoid precut sphincterotomy when possible in high-risk patients, as it significantly increases bleeding risk 4
- Do not restart anticoagulation within 48 hours of sphincterotomy without careful risk-benefit assessment 2
- Recognize that acute kidney injury (not INR or platelet count) predicts bleeding risk in some populations 1