Oral Resveratrol to Prevent Post-ERCP Pancreatitis

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Additionally, the complication of NSAID use lead to some serious physical problem bleeding. Therefore, the exclusive criteria for limiting the NSAID use is including allergy， gastrointestinal haemorrhage ，presence of coagulopathy or received anticoagulation therapy. Previous study showed that another natural compound, resveratrol, owns similar biological effect with NSAID. Firstly, it could inhibit the inflammatory response on in vivo model through inhibition of COX and IL-6 etc. Secondly, it could not influence the level of platelet and coagulation, which means safer than NSAID. Thirdly, numerous studies showed that resveratrol could effectively the progression of severe acute pancreatitis. According to data, we design the project. The purpose of this study is to determine whether oral resveratrol pre-ERCP is effective on control of Post-ERCP pancreatitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Indomethacin; Resveratrol

Criteria

Inclusion Criteria:

• Patients undergoing diagnostic or therapeutic ERCP

Exclusion Criteria:

• Unwillingness or inability to consent for the study;

• Age < 18 years old;

• Intrauterine pregnancy;

• Breastfeeding mother;

• Standard contraindications to ERCP;

• Renal failure (Cr >1.4mg/dl=120umol/l);

• Acute pancreatitis within 72 hours;

• Known pancreatic head mass;

• Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;

• ERCP for biliary stent removal or exchange without anticipated pancreatogram;

• Known active cardiovascular or cerebrovascular disease.

• Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;