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

Primary Purpose

Post-ERCP Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stilamin+common daily treatment
Common daily practice
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujian Province Hospital
  • Nanfang Hospital
  • The People' Hospital of Heilongjiang Province
  • Nanjing Drum Tower Hospital
  • The First Affiliated Hospital of Nanchang University
  • Xijing Hospital
  • Wulumuqi General Hospital of Chinese PLA
  • Hangzhou First People Hospital
  • Beijing Friendship Hospital
  • Xinan Hospital
  • Jiangsu Province of TCM
  • Changhai HospitalRecruiting
  • Eastern Hepatobiliary Surgery Hospital
  • Shanghai First People Hospital
  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stilamin+common daily treatment

common daily treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 7, 2011
Last Updated
September 25, 2011
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01431781
Brief Title
The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Official Title
A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
908 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stilamin+common daily treatment
Arm Type
Experimental
Arm Title
common daily treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Stilamin+common daily treatment
Other Intervention Name(s)
Somatostatin:Stilamin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Common daily practice
Other Intervention Name(s)
Common daily practice including:, Fasted for 6h after ERCP,, Fluid replacement,, Gastric acid inhibition,, Antiinflammatory
Intervention Description
Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
Primary Outcome Measure Information:
Title
the prophylaxis effect of Stilamin on post-ERCP pancreatitis
Description
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.
Time Frame
the incidence rate of PEP at 24 h after ERCP in two groups
Secondary Outcome Measure Information:
Title
the prophylaxis effect of Stilamin in sub-groups of patient with high risk
Description
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.
Time Frame
PEP occurence rate at 24 h after ERCP at high-risk patients in two groups
Title
compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events.
Description
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.
Time Frame
the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Zh Li, Pro.
Phone
(021)25070684
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Zh Li, Pro.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Xi Wan, Pro.
Organizational Affiliation
Shanghai First People Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bing Hu, Pro.
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Xi Zhang, Pro.
Organizational Affiliation
Hangzhou First People Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Xi Zhou, Pro.
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tang Sh Han, Pro.
Organizational Affiliation
Jiangsu Province of TCM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xun Ren, Pro.
Organizational Affiliation
The People' Hospital of Heilongjiang Province
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gang Xu Guo, Pro.
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Bie, Pro.
Organizational Affiliation
xinan hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
An Di Tian, Pro.
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guo Zh Nie, Pro.
Organizational Affiliation
Wulumuqi General Hospital of Chinese PLA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Yi, Pro.
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hua Lo Lu, Pro.
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chao Fa Zhi, Pro.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Li He, Pro.
Organizational Affiliation
Fujian Province Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Province Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The People' Hospital of Heilongjiang Province
City
Haerbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xijing Hospital
City
Xi,an
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wulumuqi General Hospital of Chinese PLA
City
Wulumuqi
State/Province
Xinjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hangzhou First People Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xinan Hospital
City
Chongqing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Province of TCM
City
Nanjing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen Zh Li, Pro.
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai First People Hospital
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tongji Hospital
City
Wuhan
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
25590178
Citation
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.
Results Reference
derived

Learn more about this trial

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

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