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The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Experimental | Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. |
|
| Glycerin | Placebo Comparator | Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indomethacin suppository | Drug | 100mg rectal indomethacin 30min before ESWL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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）. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhuan Liao, MD | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35085482 | Derived | 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. | |
| 29096689 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indomethacin | Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL |
| FG001 | Glycerin | Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Indomethacin | Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL |
| BG001 | Glycerin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 1 months |
|
From administration of rectal indomethacin/glycerin suppositories to charge from hospital, up to one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indomethacin | Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yangyang Qian | Changhai Hospital | 13818040017 | 919835863@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2017 | Sep 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| Glycerin Suppository |
| Drug |
30min before ESWL |
|
| up to 1 months |
| 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. | up to 1 months |
| up to 1 months |
| Derived |
| 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. |
Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.
Glycerin Suppository: 30min before ESWL
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 1 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 1 months |
|
|
|
| Other Pre-specified | 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）. | 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. | Not Posted | up to 1 months | Participants |
| 0 |
| 685 |
| 0 |
| 685 |
| 0 |
| 685 |
| EG001 | Glycerin | Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL | 0 | 685 | 0 | 685 | 0 | 685 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Perforation |
|
| Asymptomatic Hyperamylasemia |
|
| Hematuria |
|
| Hematemesis |
|
| Melena |
|
| Severe |
|