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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

908 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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stilamin+common daily treatment

Group Type EXPERIMENTAL

Stilamin+common daily treatment

Intervention Type DRUG

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.

common daily treatment

Group Type ACTIVE_COMPARATOR

Common daily practice

Intervention Type OTHER

Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory

Interventions

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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.

Intervention Type DRUG

Common daily practice

Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory

Intervention Type OTHER

Other Intervention Names

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Somatostatin:Stilamin Common daily practice including: Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zhaoshen Li

Director of Digestive System Department in Changhai Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Zh Li, Pro.

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Jian Xi Wan, Pro.

Role: PRINCIPAL_INVESTIGATOR

Shanghai First People Hospital

Bing Hu, Pro.

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Feng Xi Zhang, Pro.

Role: PRINCIPAL_INVESTIGATOR

Hangzhou First People Hospital

Ping Xi Zhou, Pro.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tang Sh Han, Pro.

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province of TCM

Xun Ren, Pro.

Role: PRINCIPAL_INVESTIGATOR

The People' Hospital of Heilongjiang Province

Gang Xu Guo, Pro.

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Ping Bie, Pro.

Role: PRINCIPAL_INVESTIGATOR

xinan hospital

An Di Tian, Pro.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Guo Zh Nie, Pro.

Role: PRINCIPAL_INVESTIGATOR

Wulumuqi General Hospital of Chinese PLA

Ming Yi, Pro.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Hua Lo Lu, Pro.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Chao Fa Zhi, Pro.

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Ping Li He, Pro.

Role: PRINCIPAL_INVESTIGATOR

Fujian Province Hospital

Locations

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