Rectal Indomethacin to Prevent Post ESWL-pancreatitis (RIPEP)
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|ClinicalTrials.gov Identifier: NCT02797067|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Drug: indomethacin suppository Drug: Glycerin Suppository||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.
Drug: indomethacin suppository
100mg rectal indomethacin 30min before ESWL
Placebo Comparator: Glycerin
Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.
Drug: Glycerin Suppository
30min before ESWL
- the incidence of post-ESWL pancreatitis [ Time Frame: up to 21 months ]The diagnosis of post-ESWL pancreatitis is established on consensus criteria, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the normal level 24 h after the procedure, and requires admission or extension of planned admission for least 2 days.
- the incidence and severity of asymptomatic hyperamylasemia and other post-ESWL complications [ Time Frame: up to 21 months ]
Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.
Other post-ESWL complications including bleeding, infection, steinstrasse and perforation.
Bleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.
Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.
Perforation is related to treatment.
- the severity of Post-ESWL pancreatitis measured as consensus definitions for the major complications of ERCP（endoscopic retrograde cholangiopancreatography ） [ Time Frame: up to 21 months ]Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.
- Relative risks in the subgroup of potential risk factors for post -ESWL pancreatitis will be assessed by SPSS（Statistical Product and Service Solutions，a statistical software）. [ Time Frame: up to 21 months ]Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (≥ 1/year), diabetes, CBD（common bile duct） stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency ≥100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797067
|Contact: Zhao-shen Lifirstname.lastname@example.org|
|Contact: Zhuan Liaoemail@example.com|
|Shanghai Changhai Hospital||Recruiting|
|Contact: Zhao-shen Li firstname.lastname@example.org|
|Contact: Zhuan Liao email@example.com|
|Sub-Investigator: Liang-hao Hu|
|Sub-Investigator: Yang-yang Qian|
|Principal Investigator:||Zhuan Liao, MD||Changhai Hospital|