Trial | NCT01431781  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    somatostatin ...

  • Study Participants

    908
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.
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.
Study Started
Aug 31
2011
Primary Completion
Dec 31
2012
Anticipated
Study Completion
Mar 31
2013
Anticipated
Last Update
Sep 27
2011
Estimate

Drug Stilamin+common daily treatment

dose:250 micrograms bolus intravenous in 3 minutes when ERCP starts and continuous infusion for 11 hours after ERCP. Common daily treatment: fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory.

  • Other names: Somatostatin:Stilamin

Other Common daily practice

Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory

  • Other names: Common daily practice including:, Fasted for 6h after ERCP,, Fluid replacement,, Gastric acid inhibition,, Antiinflammatory

stilamin+common daily treatment Experimental

common daily treatment Active Comparator

Criteria 

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.
No Results Posted