Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
800
High-risk patients receive 5cm 5-Fr PDS
High-risk patients receive 7cm 5-Fr PDS
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
Xijing Hospital of Digestive Diseases
Xi’an, Shanxi, China
Post-ERCP Pancreatitis
The diagnosis of PEP was established if there was new onset of upper abdominal pain associated with an increased serum amylase level of at least 3 times the upper limit of normal range at 24 hours after the procedure, and hospitalization for at least 2 nights.
Time frame: 14 days
Moderate to severe PEP
The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria.
Time frame: 14 days
Other complications of ERCP
Other complications include post sphincterotomy bleeding, biliary infection, perforation, and any adverse outcomes possibly related to ERCP that required hospital admission or a prolonged hospital stay for further management.
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.