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Futility
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The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Experimental | Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period |
|
| Placebo | Placebo Comparator | Placebo suppositories (#2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | 100 mg Indomethacin PR x 1 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Developed Acute Pancreatitis | Number of patients who developed pancreatitis following ERCP based on Atlanta Classification | From randomization to 30 days after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Developed Severe Pancreatitis | Number of patients with severe acute pancreatitis based on the Atlanta Classification | From randomization to 30 days after ERCP |
| Number of Patients Who Developed Moderately Severe Pancreatitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M Levenick, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26775631 | Background | Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9. |
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All patients who presented to Dartmouth-Hitchcock Medical Center for Endoscopic Retrograde Cholangiopancreatography (ERCP) for any reason between March 2013 and December 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Indomethacin | Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period Indomethacin: 100 mg Indomethacin PR x 1 |
| FG001 | Placebo | Placebo suppositories (#2) Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patient randomized to receive rectal indomethacin or placebo
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| ID | Title | Description |
|---|---|---|
| BG000 | Indomethacin | Indomethacin 100 mg PR x 1 in peri-procedural period Indomethacin: 100 mg Indomethacin PR x 1 |
| BG001 | Placebo | Placebo suppositories (#2) Placebo |
| 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 | Number of Patients Who Developed Acute Pancreatitis | Number of patients who developed pancreatitis following ERCP based on Atlanta Classification | Patient who randomized into the study and received either rectal indomethacin or placebo | Posted | Number | participants | From randomization to 30 days after ERCP |
|
From randomization to 30 days after ERCP
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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 | Indomethacin 100 mg PR x 1 in peri-procedural period Indomethacin: 100 mg Indomethacin PR x 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Acute Pancreatitis Leading to Death | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Bleeding | Gastrointestinal disorders | Non-systematic Assessment | Patients with any type of gastrointestinal bleeding |
The study was terminated due to indomethacin's lack of efficacy after 449 patients had been enrolled. Thus the study may be underpowered to draw conclusions about the role of indomethacin in preventing post ERCP pancreatitis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John M. Levenick | Penn State Hershey Medical Center/Dartmouth-Hitchcock Medical Center | 603-667-1332 | jlevenick@hmc.psu.edu |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
Number of patients with moderately severe pancreatitis based on Atlanta Classification
| From randomization to 30 days after ERCP |
| Number of Patients Who Developed Mild Pancreatitis | Number of patient who developed mild acute pancreatitis based on the Atlanta Classification | From randomization to 30 days after ERCP |
| Number of Patients Who Developed Gastrointestinal Bleeding | Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure | From randomization to 30 days after ERCP |
| Number of Patient Deaths | Number of patients who died from any cause from the time of ERCP until 30 days post-procedure | From randomization to 30 days after ERCP |
| Number of Patients With 30 Days Hospital Re-admission | Number of patients admitted to the hospital for any cause following ERCP | From randomization until 30 days after ERCP |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Indication | Number | participants |
|
| History of post-ERCP Pancreatitis | Number | participants |
|
| History of Previous Sphincterotomy | Number | participants |
|
| Previous ERCP | Number | participants |
|
| Difficult Cannulation | Difficult Cannulation was defined by >8 attempts at cannulation | Number | participants |
|
| Precut Biliary Sphincterotomy | Number | participants |
|
| Therapeutic Biliary Sphincterotomy | Number | participants |
|
| Therapeutic Pancreatic Sphincterotomy | Number | participants |
|
| Minor Duct Sphincterotomy | Number | participants |
|
| Balloon Dilation of Biliary Sphincter | Number | participants |
|
| Wire Cannulation of Pancreatic Duct | Number | participants |
|
| Pancreatography | Number | participants |
|
| Pancreatic Acinarization | Number | participants |
|
| Biliary Strent Placement | Number | participants |
|
| Pancreatic Stent Placement | Number | participants |
|
| Trainee Involvement | Number | participants |
|
| Concomitant Endoscopic Ultrasound with Fine Needle Aspiration (EUS/FNA) | Number | participants |
|
| Periprocedural Fluid Volume | Mean | Standard Deviation | Milliliters |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Patients Who Developed Severe Pancreatitis | Number of patients with severe acute pancreatitis based on the Atlanta Classification | Assess the number of patients who developed severe acute pancreatitis | Posted | Number | participants | From randomization to 30 days after ERCP |
|
|
|
|
| Secondary | Number of Patients Who Developed Moderately Severe Pancreatitis | Number of patients with moderately severe pancreatitis based on Atlanta Classification | Posted | Number | participants | From randomization to 30 days after ERCP |
|
|
|
|
| Secondary | Number of Patients Who Developed Mild Pancreatitis | Number of patient who developed mild acute pancreatitis based on the Atlanta Classification | Posted | Number | participants | From randomization to 30 days after ERCP |
|
|
|
|
| Secondary | Number of Patients Who Developed Gastrointestinal Bleeding | Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure | Posted | Number | participants | From randomization to 30 days after ERCP |
|
|
|
|
| Secondary | Number of Patient Deaths | Number of patients who died from any cause from the time of ERCP until 30 days post-procedure | Posted | Number | participants | From randomization to 30 days after ERCP |
|
|
|
|
| Secondary | Number of Patients With 30 Days Hospital Re-admission | Number of patients admitted to the hospital for any cause following ERCP | Posted | Number | participants | From randomization until 30 days after ERCP |
|
|
|
|
| 0 |
| 223 |
| 4 |
| 223 |
| EG001 | Placebo | Placebo suppositories (#2) Placebo | 3 | 226 | 6 | 226 |
| Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death | Gastrointestinal disorders | Non-systematic Assessment |
|
| Aspiration Post-Procedure Leading to Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
|
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