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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stilamin+common daily treatment | Experimental |
| |
| common daily treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stilamin+common daily treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen Zh Li, Pro. | Contact | (021)25070684 |
| Name | Affiliation | Role |
|---|---|---|
| Shen Zh Li, Pro. | Changhai Hospital | Principal Investigator |
| Jian Xi Wan, Pro. | Shanghai First People Hospital | Principal Investigator |
| Bing Hu, Pro. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Province Hospital | Active, not recruiting | Fuzhou | Fujian | China | ||
| Nanfang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25590178 | Derived | Bai Y, Ren X, Zhang XF, Lv NH, Guo XG, Wan XJ, Nie ZG, Han ST, Bie P, Tian DA, Ji M, Li ZS. Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial. Endoscopy. 2015 May;47(5):415-20. doi: 10.1055/s-0034-1391227. Epub 2015 Jan 15. |
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|
| Common daily practice | Other | Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory |
|
|
| PEP occurence rate at 24 h after ERCP at high-risk patients in two groups |
| 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 |
| 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, Southern Medical University | Principal Investigator |
| Ping Li He, Pro. | Fujian Province Hospital | Principal Investigator |
| 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 | Ürümqi | Xinjiang | China |
| Hangzhou First People Hospital | Active, not recruiting | Hangzhou | Zhejiang | China |
| Beijing Friendship Hospital | Active, not recruiting | Beijing | China |
| Xinan Hospital | Active, not recruiting | Chongqing | China |
| Jiangsu Province of TCM | Active, not recruiting | Nanjing | China |
| Changhai Hospital | Recruiting | Shanghai | China |
|
| Eastern Hepatobiliary Surgery Hospital | Active, not recruiting | Shanghai | China |
| Shanghai First People Hospital | Active, not recruiting | Shanghai | China |
| Tongji Hospital | Active, not recruiting | Wuhan | China |
| ID | Term |
|---|---|
| D000893 | Anti-Inflammatory Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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