COX-2 Inhibitor 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: NCT02964403|
Recruitment Status : Unknown
Verified November 2016 by Wang zheng, First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was: Not yet recruiting
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
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. The mechanism of indomethacin is dependent on COX-2 inhibitor.
According to data, we design the project. The purpose of this study is to determine whether COX-2 inhibitor is effective on control of Post-ERCP pancreatitis.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Acute||Drug: Cox-2 Drug: Indomethacin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2700 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect Observation Study of COX-2 Inhibitor to Prevent Post-ERCP Pancreatitis|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||August 2018|
Cox-2 inhibitor ParecoxibNa 40mg pre-ERCP injection
Other Name: ParecoxibNa
Active Comparator: Indomethacin
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Other Name: NSAID
- Post-ERCP Pancreatitis [ Time Frame: 30 days ]
- Moderate-to-severe Pancreatitis [ Time Frame: 30 days ]
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): NCT02964403
|Contact: Zheng Wang, MDemail@example.com|
|Contact: Jun Lvfirstname.lastname@example.orgemail@example.com|