Status:
UNKNOWN
The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Lead Sponsor:
Changhai Hospital
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pancreatitis are one of the most common complications of post-ERCP (Endoscopic Retrograde Cholangiopancreatography), the incidence rate is 5\&-10%, how to prevent PEP and hyperamylasemia is an importa...
Detailed Description
A prospective, multi-center, investigator sponsored, randomized controlled trial, 15 sites join in in China, 908 subjects will be enrolled. A descriptive analysis will be performed on primary endpoin...
Eligibility Criteria
Inclusion
- Males and females, age \> 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Exclusion
- Pregnancy or history of allergy to somatostatin.
- Renal insufficiency (Scr\>177umol/L).
- Acute myocardial infarction within 3 months of the procedure.
- History of subtotal gastrectomy (Billroth II Method).
- Symptom of shock before undergoing ERCP, such as hypotension (systolic blood pressure \< 90mmHg) or tachycardia (HR \> 120 bpm).
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent .
- Patients involved in other study within 60 days.
- Patients unfitted for the study by investigators.
- All contraindications to Stilamin.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
908 Patients enrolled
Trial Details
Trial ID
NCT01431781
Start Date
August 1 2011
End Date
March 1 2013
Last Update
September 27 2011
Active Locations (15)
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1
Fujian Province Hospital
Fuzhou, Fujian, China
2
Nanfang Hospital
Guangzhou, Guangdong, China
3
The People' Hospital of Heilongjiang Province
Haerbin, Heilongjiang, China
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China