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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
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Brief Summary:
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.

Condition or disease Intervention/treatment Phase
Pancreatitis Drug: indomethacin suppository Drug: Glycerin Suppository Phase 4

Detailed Description:
It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Indomethacin
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
  • at least 18 years old
  • provides informed consent

Exclusion Criteria:

  • contraindications to ESWL
  • suspected or established malignancy
  • pancreatic ascites
  • receiving NSAIDs within 7 days
  • contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
  • presence of coagulopathy or received anticoagulation therapy within 3 days
  • acute pancreatitis within 3 days
  • known active cardiovascular or cerebrovascular disease
  • pregnant or breastfeeding women
  • without a rectum (ie, status post-total proctocolectomy)

Information from the National Library of Medicine

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


Contacts
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Contact: Zhao-shen Li zhaoshen-li@hotmail.com
Contact: Zhuan Liao liaozhuan@smmu.edu.cn

Locations
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China
Shanghai Changhai Hospital Recruiting
Shanghai, China
Contact: Zhao-shen Li       zhaoshen-li@hotmail.com   
Contact: Zhuan Liao       liaozhuan@smmu.edu.cn   
Sub-Investigator: Liang-hao Hu         
Sub-Investigator: Yang-yang Qian         
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Zhuan Liao, MD Changhai Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhuan Liao, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02797067     History of Changes
Other Study ID Numbers: ESWL-pancreatitis
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhuan Liao, Changhai Hospital:
Extracorporeal Shock Wave lithotripsy(ESWL)
Prophylaxis
Indomethacin
Chronic pancreatitis

Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Glycerol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cryoprotective Agents
Protective Agents