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Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Primary Purpose

Post-ERCP Pancreatitis

Status
Unknown status
Phase
Phase 4
Locations
Romania
Study Type
Interventional
Intervention
indomethacin suppository
N-acetylcysteine (NAC)
Sponsored by
Grigore T. Popa University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Pancreatitis focused on measuring endoscopic retrograde cholangiopancreatography (ERCP), post-ERCP pancreatitis (PEP), Nonsteroidal anti-inflammatory drugs (NSAID's), acetylcysteine (ACC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 years and older
  • diagnosis of choledocholithiasis
  • indication for ERCP procedures
  • willingness to participate in the study
  • the ability to sign the informed consent

Exclusion Criteria:

  • presence of acute pancreatitis or other inflammatory diseases at admission
  • pregnancy
  • contraindication for NSAID administration
  • recent episode of upper digestive bleeding (less than one month)
  • hypersensibility to antioxidants hypersensibility to antioxidants
  • the necessity of a prophylactic pancreatic stent insertion
  • patients' disapproval to take part in the study

Sites / Locations

  • Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of IașiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Group A

Group B

Arm Description

Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP

Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP

Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP

Outcomes

Primary Outcome Measures

Number of patients who develop post ERCP pancreatitis
Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis

Secondary Outcome Measures

Full Information

First Posted
October 14, 2018
Last Updated
October 16, 2018
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT03708458
Brief Title
Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Official Title
Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
December 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grigore T. Popa University of Medicine and Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Pancreatitis
Keywords
endoscopic retrograde cholangiopancreatography (ERCP), post-ERCP pancreatitis (PEP), Nonsteroidal anti-inflammatory drugs (NSAID's), acetylcysteine (ACC)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP
Intervention Type
Drug
Intervention Name(s)
indomethacin suppository
Intervention Description
the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine (NAC)
Intervention Description
the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens
Primary Outcome Measure Information:
Title
Number of patients who develop post ERCP pancreatitis
Description
Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis
Time Frame
24 hours post ERCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 years and older diagnosis of choledocholithiasis indication for ERCP procedures willingness to participate in the study the ability to sign the informed consent Exclusion Criteria: presence of acute pancreatitis or other inflammatory diseases at admission pregnancy contraindication for NSAID administration recent episode of upper digestive bleeding (less than one month) hypersensibility to antioxidants hypersensibility to antioxidants the necessity of a prophylactic pancreatic stent insertion patients' disapproval to take part in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LAURA PAVEL, PhD Student
Phone
+40751129600
Email
laura_pavel_88@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
GABRIELA STEFANESCU, PhD, Lecturer
Phone
+40744244266
Email
gabriela.stefanescu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GHEORGHE BALAN, PhD, Professor
Organizational Affiliation
"GRIGORE T. POPA" UNIVERSITY OF MEDICINE AND PHARMACY IAŞI
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Gastroenterology and Hepatology - St. Spiridon County Clinical Emergency Hospital of Iași
City
Iași
ZIP/Postal Code
cod 700111
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GHEORGHE BALAN, PROFESSOR
Phone
+40732402845
Email
drbalanumfiasi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25148137
Citation
Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.
Results Reference
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PubMed Identifier
24099466
Citation
Yaghoobi M, Rolland S, Waschke KA, McNabb-Baltar J, Martel M, Bijarchi R, Szego P, Barkun AN. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Nov;38(9):995-1001. doi: 10.1111/apt.12488. Epub 2013 Sep 16.
Results Reference
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PubMed Identifier
26775631
Citation
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.
Results Reference
background
PubMed Identifier
26290647
Citation
Gooshe M, Abdolghaffari AH, Nikfar S, Mahdaviani P, Abdollahi M. Antioxidant therapy in acute, chronic and post-endoscopic retrograde cholangiopancreatography pancreatitis: An updated systematic review and meta-analysis. World J Gastroenterol. 2015 Aug 14;21(30):9189-208. doi: 10.3748/wjg.v21.i30.9189.
Results Reference
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PubMed Identifier
26074713
Citation
Fuentes-Orozco C, Davalos-Cobian C, Garcia-Correa J, Ambriz-Gonzalez G, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Chavez-Tostado M, Cuesta-Marquez LA, Alvarez-Villasenor AS, Cortes-Flores AO, Gonzalez-Ojeda A. Antioxidant drugs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis: What does evidence suggest? World J Gastroenterol. 2015 Jun 7;21(21):6745-53. doi: 10.3748/wjg.v21.i21.6745.
Results Reference
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PubMed Identifier
15990827
Citation
Katsinelos P, Kountouras J, Paroutoglou G, Beltsis A, Mimidis K, Zavos C. Intravenous N-acetylcysteine does not prevent post-ERCP pancreatitis. Gastrointest Endosc. 2005 Jul;62(1):105-11. doi: 10.1016/s0016-5107(05)01574-9.
Results Reference
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PubMed Identifier
22494121
Citation
Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
Results Reference
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PubMed Identifier
27133971
Citation
Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.
Results Reference
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Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

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