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Oral Resveratrol to Prevent Post-ERCP Pancreatitis

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ClinicalTrials.gov Identifier: NCT02947932
Recruitment Status : Unknown
Verified October 2016 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Pancreatitis, Acute Gastrointestinal Disease Drug: Resveratrol Drug: Indomethacin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Oral Resveratrol Before ERCP Redused Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Pre-ERCP group Oral resveratrol in in all patients.
Oral resveratrol was administrated within 1hour before ERCP in all patients.
Drug: Resveratrol
pre-ERCP intervention

Active Comparator: Post-ERCP rectal Indomethacin in high-risk patients.
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Drug: Indomethacin
post-ERCP intervention in high risk patients




Primary Outcome Measures :
  1. Post-ERCP Pancreatitis [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Moderate-to-severe Pancreatitis [ Time Frame: 30 days ]
    Severe pancreatitis requiring hospitalization for more than 10 d, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947932


Contacts
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Contact: Hao Sun 0086-13891813691 wangzheng0923@126.com
Contact: Jun Lv 0086-029-85323473 xjyfyllh@163.com

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02947932     History of Changes
Other Study ID Numbers: XJTU1AFCT-2016-007
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
acute pancreatitis
post-ERCP
endoscopy
Additional relevant MeSH terms:
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Pancreatitis
Gastrointestinal Diseases
Digestive System Diseases
Pancreatic Diseases
Resveratrol
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors