Rectal Indomethacin to Prevent Post-ERCP Pancreatitis (Indomethacin)
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|ClinicalTrials.gov Identifier: NCT02002650|
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : May 27, 2016
Last Update Posted : June 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post-ERCP Acute Pancreatitis||Drug: Pre-ERCP rectal Indomethacin Drug: Post-operational Rectal Indomethacin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Pre-ERCP group
Pre-ERCP rectal Indomethacin in all patients.
Drug: Pre-ERCP rectal Indomethacin
Rectal Indomethacin was administrated within 30min before ERCP in all patients.
Active Comparator: Post-ERCP group
Post-ERCP rectal Indomethacin in high-risk patients.
Drug: Post-operational Rectal Indomethacin
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
- Post-ERCP Pancreatitis [ Time Frame: 30 days ]Subjects were diagnosed with post-ERCP pancreatitis if 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 ]Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, 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): NCT02002650
|The First Hospital of Lanzhou University|
|Lanzhou, Gansu, China, 730000|
|General Hospital of NingXia Medical University|
|Yinchuan, Ningxia, China, 750004|
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|
|No. 451 Hospital|
|Xi'an, Shaanxi, China, 710054|
|The First Affiliated Hospital Of Xi'an Jiaotong University|
|Xi'an, Shaanxi, China, 710061|
|Urumqi General Hospital of Lanzhou Military Region|
|Urumqi, Xinjiang, China, 830002|
|Study Director:||Yanglin Pan, M.D.||Xijing Hospital of Digestive Diseases.The Fourth Military Medical University|