Oral Resveratrol to Prevent Post-ERCP Pancreatitis
Oral Resveratrol Before ERCP Redused Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
1 other identifier
interventional
2,700
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedOctober 28, 2016
October 1, 2016
1.2 years
October 26, 2016
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-ERCP Pancreatitis
they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
30 days
Secondary Outcomes (1)
Moderate-to-severe Pancreatitis
30 days
Study Arms (2)
Pre-ERCP group Oral resveratrol in in all patients.
EXPERIMENTALOral resveratrol was administrated within 1hour before ERCP in all patients.
Post-ERCP rectal Indomethacin in high-risk patients.
ACTIVE COMPARATORRectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Interventions
post-ERCP intervention in high risk patients
Eligibility Criteria
You may qualify if:
- Patients undergoing diagnostic or therapeutic ERCP
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2016
First Posted
October 28, 2016
Study Start
December 1, 2016
Primary Completion
March 1, 2018
Study Completion
September 1, 2018
Last Updated
October 28, 2016
Record last verified: 2016-10