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Rectal Indomethacin to Prevent Post-ERCP Pancreatitis (Indomethacin)

Primary Purpose

Post-ERCP Acute Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pre-ERCP rectal Indomethacin
Post-operational Rectal Indomethacin
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis focused on measuring Indomethacin, pancreatitis, ERCP

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing diagnostic or therapeutic ERCP.

Exclusion Criteria:

  • Unwillingness or inability to consent for the study;
  • Age < 18 years old;
  • Intrauterine pregnancy;
  • Breastfeeding mother;
  • Standard contraindications to ERCP;
  • Allergy to NSAIDs;
  • Received NSAIDs in prior 7 days;
  • Renal failure (Cr >1.4mg/dl=120umol/l);
  • Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
  • Acute pancreatitis within 72 hours;
  • Known pancreatic head mass;
  • Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
  • ERCP for biliary stent removal or exchange without anticipated pancreatogram;
  • Known active cardiovascular or cerebrovascular disease.
  • Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

Sites / Locations

  • The First Hospital of Lanzhou University
  • General Hospital of NingXia Medical University
  • Xijing Hospital of Digestive Diseases
  • No. 451 Hospital
  • The First Affiliated Hospital Of Xi'an Jiaotong University
  • Urumqi General Hospital of Lanzhou Military Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-ERCP group

Post-ERCP group

Arm Description

Pre-ERCP rectal Indomethacin in all patients.

Post-ERCP rectal Indomethacin in high-risk patients.

Outcomes

Primary Outcome Measures

Post-ERCP Pancreatitis
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.

Secondary Outcome Measures

Moderate-to-severe Pancreatitis
Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).

Full Information

First Posted
December 1, 2013
Last Updated
May 27, 2016
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02002650
Brief Title
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Acronym
Indomethacin
Official Title
Routine Rectal Indomethacin Given Before Procedure Reduced Overall Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Multi-center, Single-blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis
Keywords
Indomethacin, pancreatitis, ERCP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-ERCP group
Arm Type
Experimental
Arm Description
Pre-ERCP rectal Indomethacin in all patients.
Arm Title
Post-ERCP group
Arm Type
Active Comparator
Arm Description
Post-ERCP rectal Indomethacin in high-risk patients.
Intervention Type
Drug
Intervention Name(s)
Pre-ERCP rectal Indomethacin
Intervention Description
Rectal Indomethacin was administrated within 30min before ERCP in all patients.
Intervention Type
Drug
Intervention Name(s)
Post-operational Rectal Indomethacin
Intervention Description
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Primary Outcome Measure Information:
Title
Post-ERCP Pancreatitis
Description
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Moderate-to-severe Pancreatitis
Description
Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing diagnostic or therapeutic ERCP. Exclusion Criteria: Unwillingness or inability to consent for the study; Age < 18 years old; Intrauterine pregnancy; Breastfeeding mother; Standard contraindications to ERCP; Allergy to NSAIDs; Received NSAIDs in prior 7 days; Renal failure (Cr >1.4mg/dl=120umol/l); Active or recurrent (within 4 weeks) gastrointestinal hemorrhage; Acute pancreatitis within 72 hours; Known pancreatic head mass; Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram; ERCP for biliary stent removal or exchange without anticipated pancreatogram; Known active cardiovascular or cerebrovascular disease. Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, M.D.
Organizational Affiliation
Xijing Hospital of Digestive Diseases.The Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
General Hospital of NingXia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
No. 451 Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710054
Country
China
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Urumqi General Hospital of Lanzhou Military Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23164513
Citation
Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021.
Results Reference
result
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
result
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
derived

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Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

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