The Prophylactic Effect of Stilamin on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Launched by CHANGHAI HOSPITAL · Sep 9, 2011
Trial Information
Current as of May 27, 2025
Unknown status
Keywords
ClinConnect Summary
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 categ...
Gender
ALL
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.
About Changhai Hospital
Changhai Hospital is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence, the hospital integrates cutting-edge medical technologies and a multidisciplinary approach to patient care. Changhai Hospital actively collaborates with research organizations and healthcare professionals to conduct rigorous clinical trials aimed at developing new treatments and improving patient outcomes. By prioritizing patient safety and ethical standards, the hospital plays a pivotal role in contributing to the advancement of medical knowledge and the enhancement of therapeutic options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, , China
Fuzhou, Fujian, China
Nanjing, Jiangsu, China
Guangzhou, Guangdong, China
Haerbin, Heilongjiang, China
Nanchang, Jiangxi, China
Xi,An, Shanxi, China
Wulumuqi, Xinjiang, China
Hangzhou, Zhejiang, China
Beijing, , China
Chongqing, , China
Nanjing, , China
Shanghai, , China
Shanghai, , China
Wuhan, , China
Patients applied
Trial Officials
Shen Zh Li, Pro.
Principal Investigator
Changhai Hospital
Jian Xi Wan, Pro.
Principal Investigator
Shanghai First People Hospital
Bing Hu, Pro.
Principal Investigator
Eastern Hepatobiliary Surgery Hospital
Feng Xi Zhang, Pro.
Principal Investigator
Hangzhou First People Hospital
Ping Xi Zhou, Pro.
Principal Investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Tang Sh Han, Pro.
Principal Investigator
Jiangsu Province of TCM
Xun Ren, Pro.
Principal Investigator
The People' Hospital of Heilongjiang Province
Gang Xu Guo, Pro.
Principal Investigator
Xijing Hospital
Ping Bie, Pro.
Principal Investigator
xinan hospital
An Di Tian, Pro.
Principal Investigator
Tongji Hospital
Guo Zh Nie, Pro.
Principal Investigator
Wulumuqi General Hospital of Chinese PLA
Ming Yi, Pro.
Principal Investigator
Beijing Friendship Hospital
Hua Lo Lu, Pro.
Principal Investigator
The First Affiliated Hospital of Nanchang University
Chao Fa Zhi, Pro.
Principal Investigator
Nanfang Hospital, Southern Medical University
Ping Li He, Pro.
Principal Investigator
Fujian Province Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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