NCT01431781

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 908 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
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	Common daily practice	Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2011-09-12
• Last updated: 2011-09-27

Locations

15 sites across 1 country: China