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

September 25, 2011 updated by: Zhaoshen Li, Changhai Hospital

A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

908

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shen Zh Li, Pro.
  • Phone Number: (021)25070684

Study Locations

  • China
      • Beijing, China
        • Active, not recruiting
        • Beijing Friendship Hospital
      • Chongqing, China
        • Active, not recruiting
        • Xinan Hospital
      • Nanjing, China
        • Active, not recruiting
        • Jiangsu Province of TCM
      • Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Principal Investigator:
          • Shen Zh Li, Pro.
      • Shanghai, China
        • Active, not recruiting
        • Eastern Hepatobiliary Surgery Hospital
      • 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
      • Nanjing, Jiangsu, China
        • Active, not recruiting
        • Nanjing Drum Tower Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Active, not recruiting
        • The First Affiliated Hospital of Nanchang University
    • Shanxi
      • Xi,an, Shanxi, China
        • Active, not recruiting
        • Xijing Hospital
    • Xinjiang
      • Wulumuqi, Xinjiang, China
        • Active, not recruiting
        • Wulumuqi General Hospital of Chinese PLA
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Active, not recruiting
        • Hangzhou First People Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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 Names:
  • Somatostatin:Stilamin
ACTIVE_COMPARATOR: common daily treatment
Other: Common daily practice
Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
Other Names:
  • Common daily practice including:
  • Fasted for 6h after ERCP,
  • Fluid replacement,
  • Gastric acid inhibition,
  • Antiinflammatory

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

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (ESTIMATE)

September 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 25, 2011

Last Verified

September 1, 2011

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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