The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Naval Military Medical University

Status

Unknown

Conditions

Post-ERCP Acute Pancreatitis

Treatments

Drug: Stilamin+common daily treatment

Other: Common daily practice

Study type

Interventional

Funder types

Other

Identifiers

NCT01431781

02324789755

Details and patient eligibility

About

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.

Full 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 endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.

Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Enrollment

908 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females, age > 18 years.
Normal amylase level before undergoing ERCP.
Signed inform consent form and agreed to follow-up on time.

Exclusion criteria

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.