What are the guidelines for Endoscopic Retrograde Cholangiopancreatography (ERCP) sphincteroplasty in a patient with potential risks and underlying conditions such as coagulopathy, liver disease, or previous pancreatic surgery?

ERCP Sphincteroplasty Guidelines

ERCP sphincterotomy is classified as a high-risk endoscopic procedure with significant bleeding risk, requiring specific pre-procedural assessment and risk mitigation strategies, particularly in patients with coagulopathy, liver disease, or complex anatomy. 1

Pre-Procedural Assessment Requirements

Mandatory Laboratory Testing

• All patients undergoing biliary sphincterotomy must have FBC and INR/PT checked prior to ERCP 1
• If deranged clotting or thrombocytopenia is identified, attempts should be made to correct coagulopathy before performing sphincterotomy 1
• If coagulopathy cannot be corrected, initial therapy should involve endoscopic stenting rather than sphincterotomy due to inherently lower bleeding risk 1

Anticoagulation Management

For patients on warfarin (low thrombotic risk):

• Discontinue warfarin 5 days before procedure 1
• Check INR prior to procedure to ensure <1.5 1

For patients on warfarin (high thrombotic risk):

• Temporarily discontinue warfarin and substitute with LMWH 1
• Stop warfarin 5 days before endoscopy, start LMWH 2 days after stopping warfarin 1
• Check INR prior to procedure to ensure <1.5 1

For patients on DOACs:

• Last dose should be taken at least 48 hours before the procedure 1
• For dabigatran with CrCl 30-50 mL/min, last dose should be taken 72 hours prior 1

For patients on antiplatelet therapy (high thrombotic risk):

• Continue aspirin and liaise with cardiologist about risk/benefit of discontinuing P2Y12 receptor antagonists 1

Post-ERCP Pancreatitis Prophylaxis

Universal Prophylaxis

Rectal NSAIDs (100 mg diclofenac or indomethacin) should be administered at the time of ERCP to all patients without contraindication to NSAIDs 1

Pancreatic Stent Placement

• Consider prophylactic pancreatic stent (5F) if repeated pancreatic duct cannulation occurs (>1 pancreatic wire passage) 1
• Pancreatic stent placement reduces PEP risk in high-risk patients but requires appropriate training, as failed attempts dramatically increase PEP risk 1
• Reassess patients after stent insertion to confirm spontaneous migration via plain abdominal X-ray 1

Infection Prophylaxis

Routine prophylactic antibiotics should be administered before ERCP in patients with PSC or when complete drainage is anticipated to be difficult 1

Procedural Risks and Complications

Overall Complication Rates

• Major complications (pancreatitis, cholangitis, hemorrhage, perforation): 4-5.2% 1
• Mortality risk: 0.4% 1
• Post-procedure pancreatitis with sphincterotomy: up to 10% 1

Specific Considerations

In patients with sclerosing cholangitis or biliary stricture:

• ERCP should be performed with caution, as suppurative cholangitis may be induced by endoscopic catheter manipulation of obstructed biliary system 1

In patients with previous gastroenteric anastomoses:

• ERCP is technically difficult as advancing the endoscope into the biliopancreatic limb is challenging 1

Alternative Techniques

Endoscopic Papillary Balloon Dilation (EPBD)

EPBD is suggested as an alternative to sphincterotomy for extracting CBD stones <8 mm, especially in patients with coagulopathy or altered anatomy 2

• Balloon sphincteroplasty is safe and effective for stones <12 mm; larger stones may require mechanical lithotripsy 3
• No papillary hemorrhage observed with sphincteroplasty; uncomplicated pancreatitis occurred in 5% 3

Sphincteroplasty for Large Stones

• For choledochoceles with large CBD dilation (>15-30 mm), sphincteroplasty may be necessary as sphincterotomy alone may be insufficient for stone clearance 4

Post-Procedure Management

If antiplatelet or anticoagulant therapy is discontinued, it should be resumed up to 48 hours after the procedure depending on perceived bleeding and thrombotic risks 1

Critical Pitfalls to Avoid

• Never perform speculative ERCP or sphincterotomy without proven bile duct stones - this is the most common allegation in ERCP malpractice cases (54% of cases) 5
• Do not proceed with sphincterotomy if INR >1.5 or platelet count <50,000 × 10³/μL - use stenting instead 6
• Avoid pancreatic duct cannulation or contrast-filling at ERCP for CBD stones wherever possible 1
• Do not delay urgent ERCP for cholangitis due to coagulopathy concerns - the mortality benefit of drainage outweighs bleeding risk in acute suppurative cholangitis 7, 6