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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01431781
• Other study ID #: 02324789755
• Status: Recruiting
• Phase: N/A
• First received: September 7, 2011
• Last updated: September 25, 2011
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2011
• Source: Changhai Hospital
• Contact: Shen Zh Li, Pro.
• Phone: (021)25070684
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 908
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing
China	Xinan Hospital	Chongqing
China	Fujian Province Hospital	Fuzhou	Fujian
China	Nanfang Hospital	Guangzhou	Guangdong
China	The People' Hospital of Heilongjiang Province	Haerbin	Heilongjiang
China	Hangzhou First People Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province of TCM	Nanjing
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Changhai Hospital	Shanghai
China	Eastern Hepatobiliary Surgery Hospital	Shanghai
China	Shanghai First People Hospital	Shanghai
China	Tongji Hospital	Wuhan
China	Wulumuqi General Hospital of Chinese PLA	Wulumuqi	Xinjiang
China	Xijing Hospital	Xi,an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prophylaxis effect of Stilamin on post-ERCP pancreatitis	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.	the incidence rate of PEP at 24 h after ERCP in two groups	Yes
Secondary	the prophylaxis effect of Stilamin in sub-groups of patient with high risk	If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who 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).; Descriptive statistics will be produced for all continuous variables.Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.	PEP occurence rate at 24 h after ERCP at high-risk patients in two groups	Yes
Secondary	compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events.	Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms.During the study, any unexpected medical issue will be called adverse event.; Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.	the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups	Yes