Back to resultsRectal Indomethacin to Prevent Post ESWL-pancreatitis (RIPEP)
Primary Purpose
Pancreatitis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
indomethacin suppository
Glycerin Suppository
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatitis focused on measuring Extracorporeal Shock Wave lithotripsy(ESWL), Prophylaxis, Indomethacin, Chronic pancreatitis
Eligibility Criteria
Inclusion Criteria:
- any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
- at least 18 years old
- provides informed consent
Exclusion Criteria:
- readmitted to the hospital during the enrollment of the study
- 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)
Sites / Locations
- Shanghai Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Indomethacin
Glycerin
Arm Description
Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.
Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.
Outcomes
Primary Outcome Measures
the Incidence of Post-ESWL Pancreatitis
Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
Secondary Outcome Measures
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications
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 ）
Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02797067
Brief Title
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
Acronym
RIPEP
Official Title
Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
August 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Extracorporeal Shock Wave lithotripsy(ESWL), Prophylaxis, Indomethacin, Chronic pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indomethacin
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.
Arm Title
Glycerin
Arm Type
Placebo Comparator
Arm Description
Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.
Intervention Type
Drug
Intervention Name(s)
indomethacin suppository
Intervention Description
100mg rectal indomethacin 30min before ESWL
Intervention Type
Drug
Intervention Name(s)
Glycerin Suppository
Intervention Description
30min before ESWL
Primary Outcome Measure Information:
Title
the Incidence of Post-ESWL Pancreatitis
Description
Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
Time Frame
up to 1 months
Secondary Outcome Measure Information:
Title
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications
Description
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.
Time Frame
up to 1 months
Title
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）
Description
Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.
Time Frame
up to 1 months
Other Pre-specified Outcome Measures:
Title
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）.
Description
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.
Time Frame
up to 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
at least 18 years old
provides informed consent
Exclusion Criteria:
readmitted to the hospital during the enrollment of the study
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35085482
Citation
Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.
Results Reference
derived
PubMed Identifier
29096689
Citation
Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7.
Results Reference
derived
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Rectal Indomethacin to Prevent Post ESWL-pancreatitis
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