Clinical trial NCT01431781: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: the prophylaxis effect of Stilamin on post-ERCP pancreatitis
timeFrame: the incidence rate of PEP at 24 h after ERCP in two groups
Secondary outcomes:
measure: the prophylaxis effect of Stilamin in sub-groups of patient with high risk
timeFrame: PEP occurence rate at 24 h after ERCP at high-risk patients in two groups
measure: compare Stilamin treated group with the other group on the incidence of hyperamylasemia/adverse events.
timeFrame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Province Hospital
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Haerbin
country: China
facility: The People' Hospital of Heilongjiang Province
state: Heilongjiang
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Xi,an
country: China
facility: Xijing Hospital
state: Shanxi
city: Wulumuqi
country: China
facility: Wulumuqi General Hospital of Chinese PLA
state: Xinjiang
city: Hangzhou
country: China
facility: Hangzhou First People Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Chongqing
country: China
facility: Xinan Hospital
city: Nanjing
country: China
facility: Jiangsu Province of TCM
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
city: Shanghai
country: China
facility: Shanghai First People Hospital
city: Wuhan
country: China
facility: Tongji Hospital
Study officials:
affiliation: Changhai Hospital
name: Shen Zh Li, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai First People Hospital
name: Jian Xi Wan, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Bing Hu, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hangzhou First People Hospital
name: Feng Xi Zhang, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Ping Xi Zhou, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Province of TCM
name: Tang Sh Han, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: The People' Hospital of Heilongjiang Province
name: Xun Ren, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Xijing Hospital
name: Gang Xu Guo, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: xinan hospital
name: Ping Bie, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: An Di Tian, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wulumuqi General Hospital of Chinese PLA
name: Guo Zh Nie, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Ming Yi, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Hua Lo Lu, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Chao Fa Zhi, Pro.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Province Hospital
name: Ping Li He, Pro.
role: PRINCIPAL_INVESTIGATOR
References:
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.