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

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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

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

Common daily practice

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

Sponsors & Collaborators

• Changhai Hospital

  lead OTHER

Principal Investigators

• Shen Zh Li, Pro. · Changhai Hospital

• Jian Xi Wan, Pro. · Shanghai First People Hospital

• Bing Hu, Pro. · Eastern Hepatobiliary Surgery Hospital

• Feng Xi Zhang, Pro. · Hangzhou First People Hospital

• Ping Xi Zhou, Pro. · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• Tang Sh Han, Pro. · Jiangsu Province of TCM

• Xun Ren, Pro. · The People' Hospital of Heilongjiang Province

• Gang Xu Guo, Pro. · Xijing Hospital

• Ping Bie, Pro. · xinan hospital

• An Di Tian, Pro. · Tongji Hospital

• Guo Zh Nie, Pro. · Wulumuqi General Hospital of Chinese PLA

• Ming Yi, Pro. · Beijing Friendship Hospital

• Hua Lo Lu, Pro. · The First Affiliated Hospital of Nanchang University

• Chao Fa Zhi, Pro. · Nanfang Hospital, Southern Medical University

• Ping Li He, Pro. · Fujian Province Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2012-12-31

Completion

2013-03-31

Countries

• China

Study Locations