A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis

NCT01431781 NA UNKNOWN

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 important issue, somatostatin is widely used in the field of pancreas treatment. In order to explore the effects of somatostatin on prevent PEP(post-ERCP Pancreatitis), 908 subjects will be enrolled in two group in the study, one group is given common treatment, the other uses somatostatin in the base of common treatment.

Details

Lead sponsor	Changhai Hospital
Phase	NA
Status	UNKNOWN
Enrolment	908
Start date	2011-08
Completion	2013-03

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

• Stilamin+common daily treatment
• Common daily practice

Primary outcomes

• the prophylaxis effect of Stilamin on post-ERCP pancreatitis — the incidence rate of PEP at 24 h after ERCP in two groups
  If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours, patients also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). A descriptive analysis will be performed on primary endpoint, containing frequecency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.

Countries

China