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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Changhai Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01431781
First received: September 7, 2011
Last updated: September 25, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Post-ERCP Acute Pancreatitis
Drug: Stilamin+common daily treatment
Other: Common daily practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Multi-center, Investigator Sponsored, Randomized Controlled Trial-- The Prophylactic Effect of Stilamin on Post-ERCP Pancreatitis

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • the prophylaxis effect of Stilamin on post-ERCP pancreatitis [ Time Frame: the incidence rate of PEP at 24 h after ERCP in two groups ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: PEP occurence rate at 24 h after ERCP at high-risk patients in two groups ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 908
Study Start Date: August 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431781

Contacts
Contact: Shen Zh Li, Pro. (021)25070684

Locations
China, Fujian
Fujian Province Hospital Active, not recruiting
Fuzhou, Fujian, China
China, Guangdong
Nanfang Hospital Active, not recruiting
Guangzhou, Guangdong, China
China, Heilongjiang
The People' Hospital of Heilongjiang Province Active, not recruiting
Haerbin, Heilongjiang, China
China, Jiangsu
Nanjing Drum Tower Hospital Active, not recruiting
Nanjing, Jiangsu, China
China, Jiangxi
The First Affiliated Hospital of Nanchang University Active, not recruiting
Nanchang, Jiangxi, China
China, Shanxi
Xijing Hospital Active, not recruiting
Xi,an, Shanxi, China
China, Xinjiang
Wulumuqi General Hospital of Chinese PLA Active, not recruiting
Wulumuqi, Xinjiang, China
China, Zhejiang
Hangzhou First People Hospital Active, not recruiting
Hangzhou, Zhejiang, China
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
Eastern Hepatobiliary Surgery Hospital Active, not recruiting
Shanghai, China
Shanghai First People Hospital Active, not recruiting
Shanghai, China
Changhai Hospital Recruiting
Shanghai, China
Principal Investigator: Shen Zh Li, Pro.         
Tongji Hospital Active, not recruiting
Wuhan, China
Sponsors and Collaborators
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. Nanjing Drum Tower Hospital
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
  More Information

No publications provided

Responsible Party: Zhaoshen Li, Director of Digestive System Department in Changhai Hospital, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01431781     History of Changes
Other Study ID Numbers: 02324789755
Study First Received: September 7, 2011
Last Updated: September 25, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents
Somatostatin
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014