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Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis (IND+LRPEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641561
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Shaffer R S Mok, The Cooper Health System

Brief Summary:
Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.

Condition or disease Intervention/treatment Phase
Post-ERCP Acute Pancreatitis Drug: Indomethacin Drug: Lactated Ringer's Solution Drug: Normal Saline Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) - Induced Pancreatitis Using Aggressive Lactated Ringer's Infusion and/or Rectal Indomethacin
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Placebo Comparator: A (NS+Placebo)
Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure )
Drug: Normal Saline
standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.
Other Name: NS

Drug: Placebo
Placebo would be a suppository 50 mg x 2

Active Comparator: B (NS+IND)
Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure )
Drug: Indomethacin
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis
Other Name: IND

Drug: Normal Saline
standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.
Other Name: NS

Active Comparator: C (LR+Placebo)
Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure)
Drug: Lactated Ringer's Solution
Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
Other Name: LR

Drug: Placebo
Placebo would be a suppository 50 mg x 2

Experimental: D (LR+IND)
Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure)
Drug: Indomethacin
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis
Other Name: IND

Drug: Lactated Ringer's Solution
Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
Other Name: LR




Primary Outcome Measures :
  1. The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal [ Time Frame: 30 days after ERCP ]
    amylase or lipase

  2. The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis [ Time Frame: 30 days after ERCP ]
    Imaging may include Computer Tomography


Secondary Outcome Measures :
  1. The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below) [ Time Frame: 30 days after ERCP ]
    bilateral opacities on chest imaging not explained by other lung pathology, respiratory failure not explained by heart failure or volume, and overload and a pulmonary arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio under 300, PaO2/FiO2 ratio is the partial pressure arterial oxygen and fraction of inspired oxygen

  2. The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below) [ Time Frame: 30 days after ERCP ]
    Heart rate > 90 beats per minutes

  3. The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below) [ Time Frame: 30 days after ERCP ]
    Respiratory rate > 20 breaths per minute

  4. The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below) [ Time Frame: 30 days after ERCP ]
    PaCO2 < 4.3 kilopascal (kPa) (32 mmHg)

  5. The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below) [ Time Frame: 30 days after ERCP ]
    Temperature < 36°C(96.8°F) or > 38°C(100.4°F)

  6. The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below) [ Time Frame: 30 days after ERCP ]
    white blood cell (WBC) count < 4000 cells/mm³ (4 x 109 cells/L)

  7. The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below) [ Time Frame: 30 days after ERCP ]
    > 10% immature neutrophils (band forms).

  8. The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture [ Time Frame: 30 days after ERCP ]
    positive blood culture

  9. The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test [ Time Frame: 30 days after ERCP ]
    creatinine > 1.5 milligrams/deciliter (mg/dL)

  10. The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR) [ Time Frame: 30 days after ERCP ]
    INR > 1.5

  11. The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst [ Time Frame: 30 days after ERCP ]
    Imaging may include Computer Tomography

  12. The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess [ Time Frame: 30 days after ERCP ]
    Imaging may include Computer Tomography

  13. The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation [ Time Frame: 30 days after ERCP ]
    Imaging may include Computer Tomography

  14. The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report [ Time Frame: 30 days after ERCP ]
  15. The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting [ Time Frame: 30 days after ERCP ]
  16. The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting [ Time Frame: 30 days after ERCP ]
  17. The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days [ Time Frame: 30 days after ERCP ]
  18. The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting [ Time Frame: 30 days after ERCP ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1 Subjects who are undergoing endoscopic retrograde cholangiopancreatography (ERCP)

  • Age > 18 years
  • Non-pregnant
  • Non-prisoners
  • Subjects who can sign informed consent
  • Serum Creatinine < 1.2 milligrams/deciliter (mg/dL)
  • Subjects without renal failure (acute or chronic)
  • Subjects without congestive heart failure (ejection fraction < 40%)
  • Subjects without cirrhosis of the liver
  • Subjects without allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
  • Subjects not on non-steroidal anti-inflammatory drugs NSAIDS prior to enrollment

Exclusion Criteria:

  • Subjects who are not undergoing ERCP
  • Age < 18 years
  • Pregnancy
  • Prisoners
  • Subjects lacking the capacity to consent for themselves
  • Serum Creatinine > 1.2 milligrams/deciliter (mg/dL)
  • Subjects with renal failure (acute and chronic)
  • Subjects with congestive heart failure (ejection fraction < 40%)
  • Subjects with cirrhosis of the liver
  • Subjects with allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
  • Subjects with gastrointestinal hemorrhage
  • Subjects on chronic non-steroidal anti-inflammatory drugs NSAIDS
  • Subjects with acute pancreatitis the day of their procedure (CITE 1-3)(APPENDIX 1)

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): NCT02641561


Locations
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United States, New Jersey
Cooper Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Investigators
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Principal Investigator: Shaffer RS Mok, MD, MBS The Cooper Health System
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shaffer R S Mok, Clinical Instructor, The Cooper Health System
ClinicalTrials.gov Identifier: NCT02641561    
Other Study ID Numbers: 14-091
First Posted: December 29, 2015    Key Record Dates
Results First Posted: February 27, 2018
Last Update Posted: February 27, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shaffer R S Mok, The Cooper Health System:
Pancreatitis
ERCP
Indomethacin
Lactated ringer's
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
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