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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01431781
Study type Interventional
Source Changhai Hospital
Contact Shen Zh Li, Pro.
Phone (021)25070684
Status Recruiting
Phase N/A
Start date August 2011
Completion date March 2013

See also
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Completed NCT00222092 - Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers Phase 4
Completed NCT05310409 - PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms
Not yet recruiting NCT06260878 - Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis Phase 4
Not yet recruiting NCT04770857 - Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis
Completed NCT02641561 - Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis Phase 3
Active, not recruiting NCT04145336 - 7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients N/A
Completed NCT03629600 - Trial of Aggressive Hydration Versus Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis Phase 2/Phase 3
Recruiting NCT03756116 - Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide N/A
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Completed NCT02308891 - A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis N/A
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Recruiting NCT05857514 - Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis N/A
Recruiting NCT05267379 - An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Recruiting NCT05947461 - Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac N/A
Completed NCT03098082 - Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis N/A
Recruiting NCT02839356 - Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis Phase 4
Recruiting NCT02830984 - ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP N/A
Completed NCT01673763 - Post-ERCP Pancreatitis Prevention by Stent Insertion N/A