- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shen Zh Li, Pro.
- Phone Number: (021)25070684
Study Locations
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-
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Beijing, China
- Active, not recruiting
- Beijing Friendship Hospital
-
Chongqing, China
- Active, not recruiting
- Xinan Hospital
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Nanjing, China
- Active, not recruiting
- Jiangsu Province of TCM
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Shanghai, China
- Recruiting
- Changhai Hospital
-
Principal Investigator:
- Shen Zh Li, Pro.
-
Shanghai, China
- Active, not recruiting
- Eastern Hepatobiliary Surgery Hospital
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Shanghai, China
- Active, not recruiting
- Shanghai First People Hospital
-
Wuhan, China
- Active, not recruiting
- Tongji Hospital
-
-
Fujian
-
Fuzhou, Fujian, China
- Active, not recruiting
- Fujian Province Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Active, not recruiting
- Nanfang Hospital
-
-
Heilongjiang
-
Haerbin, Heilongjiang, China
- Active, not recruiting
- The People' Hospital of Heilongjiang Province
-
-
Jiangsu
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Nanjing, Jiangsu, China
- Active, not recruiting
- Nanjing Drum Tower Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, China
- Active, not recruiting
- The First Affiliated Hospital of Nanchang University
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-
Shanxi
-
Xi,an, Shanxi, China
- Active, not recruiting
- Xijing Hospital
-
-
Xinjiang
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Wulumuqi, Xinjiang, China
- Active, not recruiting
- Wulumuqi General Hospital of Chinese PLA
-
-
Zhejiang
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Hangzhou, Zhejiang, China
- Active, not recruiting
- Hangzhou First People Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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:
|
ACTIVE_COMPARATOR: common daily treatment
|
Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 incidence rate of PEP at 24 h after ERCP in two groups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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.
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. |
the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02324789755
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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