Oral Resveratrol to Prevent Post-ERCP Pancreatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Acute Gastrointestinal Disease||Drug: Resveratrol Drug: Indomethacin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2700 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Pre-ERCP group Oral resveratrol in in all patients.
Oral resveratrol was administrated within 1hour before ERCP in all patients.
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.
post-ERCP intervention in high risk patients
- 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.
- 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).
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
|Contact: Hao Sunemail@example.com|
|Contact: Jun Lvfirstname.lastname@example.org|