Table 1. Definitions of major complications of pancreatic extracorporeal shock wave lithotripsy (P-ESWL).

Complications 1	Mild	Moderate	Severe
Post-ESWL pancreatitis	Clinical pancreatitis, amylase at least three times the normal level > 24 hours after the procedure, requiring admission or extension of planned admission from 2 days to 3 days	Requiring hospitalization of 4 – 10 days	Hospitalization for > 10 days, pseudocyst, or intervention (percutaneous drainage or surgery)
Bleeding 2	Clinical evidence of bleeding, hemoglobin drop < 3 g, no transfusion required	Transfusion ( ≤ 4 units), no angiographic intervention, or surgery	Transfusion of ≥ 5 units or intervention (angiographic or surgical)
Infection	Temperature > 38 C for 24 – 48 hours	Requiring > 3 days of hospital treatment	Abscess, septic shock, or intervention (percutaneous drainage or surgery)
Steinstrasse 3	Severe abdominal pain without other post-ESWL complications	Combined with other complications, or requiring > 3 days of hospital treatment	Combined with other complications; hospitalization for > 10 days, or surgery
Perforation	Possible, or very slight, leak of fluid, treatable with fluids and suction for ≤ 3 days	Any definite perforation treated medically for 4 – 10 days	Medical treatment for > 10 days or intervention (percutaneous or surgical)

¹Splenic rupture, pancreaticobiliary fistula, and other rare complications were not included in this classification of complications.

²Acute gastrointestinal mucosal injury was not included, but was classified as a transient adverse event.

³Steinstrasse refers to: acute stone incarceration in the papilla leading to poor pancreatic juice drainage; computed tomography scan showing a more dilated pancreatic duct with/without acute pancreatitis; severe abdominal pain that cannot be relieved by analgesics but can be relieved by emergency endoscopic retrograde cholangiopancreatography (ERCP) or ESWL.