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
1 other identifier
interventional
908
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 27, 2011
September 1, 2011
1.3 years
September 7, 2011
September 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
the prophylaxis effect of Stilamin in sub-groups of patient with high risk
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.
the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Study Arms (2)
stilamin+common daily treatment
EXPERIMENTALcommon daily treatment
ACTIVE COMPARATORInterventions
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.
Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
Eligibility Criteria
You may qualify if:
- Males and females, age \> 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Fujian Province Hospital
Fuzhou, Fujian, China
Nanfang Hospital
Guangzhou, Guangdong, China
The People' Hospital of Heilongjiang Province
Haerbin, Heilongjiang, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Xijing Hospital
Xi’an, Shanxi, China
Wulumuqi General Hospital of Chinese PLA
Ürümqi, Xinjiang, China
Hangzhou First People Hospital
Hangzhou, Zhejiang, China
Beijing Friendship Hospital
Beijing, China
Xinan Hospital
Chongqing, China
Jiangsu Province of TCM
Nanjing, China
Changhai Hospital
Shanghai, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
Shanghai First People Hospital
Shanghai, China
Tongji Hospital
Wuhan, China
Related Publications (1)
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.
PMID: 25590178DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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, Southern Medical University
- PRINCIPAL INVESTIGATOR
Ping Li He, Pro.
Fujian Province Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Digestive System Department in Changhai Hospital
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 12, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
September 27, 2011
Record last verified: 2011-09