NCT04145336

7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients

7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients: a Multicentre, Single-blinded, Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
DEVICE	5cm 5-Fr PDS	High-risk patients receive 5cm 5-Fr PDS
DEVICE	7cm 5-Fr PDS	High-risk patients receive 7cm 5-Fr PDS
DRUG	Indomethacin	All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.

Timeline

• Start date: 2019-10-15
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2019-10-30
• Last updated: 2019-10-30

Locations

1 site across 1 country: China