The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01431781|
Recruitment Status : Unknown
Verified September 2011 by Zhaoshen Li, Changhai Hospital.
Recruitment status was: Recruiting
First Posted : September 12, 2011
Last Update Posted : September 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Post-ERCP Acute Pancreatitis||Drug: Stilamin+common daily treatment Other: Common daily practice||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||908 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
|Experimental: stilamin+common daily treatment||
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 Name: Somatostatin:Stilamin
|Active Comparator: common daily treatment||
Other: Common daily practice
Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
- the prophylaxis effect of Stilamin on post-ERCP pancreatitis [ Time Frame: 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.
- the prophylaxis effect of Stilamin in sub-groups of patient with high risk [ Time Frame: PEP occurence rate at 24 h after ERCP at high-risk patients in two groups ]
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.
- compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events. [ Time Frame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431781
|Contact: Shen Zh Li, Pro.||(021)25070684|
|Fujian Province Hospital||Active, not recruiting|
|Fuzhou, Fujian, China|
|Nanfang Hospital||Active, not recruiting|
|Guangzhou, Guangdong, China|
|The People' Hospital of Heilongjiang Province||Active, not recruiting|
|Haerbin, Heilongjiang, China|
|Nanjing Drum Tower Hospital||Active, not recruiting|
|Nanjing, Jiangsu, China|
|The First Affiliated Hospital of Nanchang University||Active, not recruiting|
|Nanchang, Jiangxi, China|
|Xijing Hospital||Active, not recruiting|
|Xi,an, Shanxi, China|
|Wulumuqi General Hospital of Chinese PLA||Active, not recruiting|
|Wulumuqi, Xinjiang, China|
|Hangzhou First People Hospital||Active, not recruiting|
|Hangzhou, Zhejiang, China|
|Beijing Friendship Hospital||Active, not recruiting|
|Xinan Hospital||Active, not recruiting|
|Jiangsu Province of TCM||Active, not recruiting|
|Principal Investigator: Shen Zh Li, Pro.|
|Eastern Hepatobiliary Surgery Hospital||Active, not recruiting|
|Shanghai First People Hospital||Active, not recruiting|
|Tongji Hospital||Active, not recruiting|
|Principal Investigator:||Shen Zh Li, Pro.||Changhai Hospital|
|Principal Investigator:||Jian Xi Wan, Pro.||Shanghai First People Hospital|
|Principal Investigator:||Bing Hu, Pro.||Eastern Hepatobiliary Surgery Hospital|
|Principal Investigator:||Feng Xi Zhang, Pro.||Hangzhou First People Hospital|
|Principal Investigator:||Ping Xi Zhou, Pro.||The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|
|Principal Investigator:||Tang Sh Han, Pro.||Jiangsu Province of TCM|
|Principal Investigator:||Xun Ren, Pro.||The People' Hospital of Heilongjiang Province|
|Principal Investigator:||Gang Xu Guo, Pro.||Xijing Hospital|
|Principal Investigator:||Ping Bie, Pro.||Xinan Hospital|
|Principal Investigator:||An Di Tian, Pro.||Tongji Hospital|
|Principal Investigator:||Guo Zh Nie, Pro.||Wulumuqi General Hospital of Chinese PLA|
|Principal Investigator:||Ming Yi, Pro.||Beijing Friendship Hospital|
|Principal Investigator:||Hua Lo Lu, Pro.||The First Affiliated Hospital of Nanchang University|
|Principal Investigator:||Chao Fa Zhi, Pro.||Nanfang Hospital of Southern Medical University|
|Principal Investigator:||Ping Li He, Pro.||Fujian Province Hospital|