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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01431781
Other study ID # 02324789755
Secondary ID
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


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
See also
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Completed NCT00222092 - Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers Phase 4
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Completed NCT03098082 - Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis N/A
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