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Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin

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ClinicalTrials.gov Identifier: NCT02709421
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

Brief Summary:
Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.

Condition or disease
Healthy

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Study Type : Observational
Actual Enrollment : 790 participants
Time Perspective: Retrospective
Official Title: Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin
Study Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort
Indomethacin Group

All the patients with high risks of PEP received administration of one single dose of 100mg rectal indomethacin after ERCP.

Patients were considered high risk of PEP if they met one of the following criteria: clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, cannulation time≥10 minutes; pneumatic dilatation of an intact biliary sphincter, ≥3 inadvertent pancreatic duct cannulation, opacification of pancreatic acini, or the acquisition of a cytologic specimen from the pancreatic duct with the use of a brush or forceps.




Primary Outcome Measures :
  1. Overall PEP rate [ Time Frame: 1 year ]
    PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.


Secondary Outcome Measures :
  1. The rate of moderate-severe pancreatitis [ Time Frame: 1 year ]
  2. Overall ERCP-related complication rate [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent ERCP and received administration of rectal indomethacin.
Criteria

Inclusion Criteria:

  • Undergoing diagnostic or interventional ERCP
  • Receiving administration of rectal indomethacin(100mg) after ERCP
  • High risk patients determined at the discretions of endoscopists

Exclusion Criteria:

  • Dose other than 100mg
  • Acute pancreatitis within 3 days before ERCP
  • Average risk patients at the discretions of endoscopists
  • Using NSAIDs within 7 days before ERCP
  • Without cannulation attempts
  • Administration of rectal indomethacin before or during ERCP

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): NCT02709421


Locations
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China, Fujian
Department of gastroenterology,Chinese PLA 174 Hospital
Xiamen, Fujian, China
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Yanglin Pan Xijing Hospital of Disgestive Diseases.The Fourth Military University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02709421     History of Changes
Other Study ID Numbers: 20160224-2
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: June 2016
Keywords provided by Yanglin Pan, Fourth Military Medical University:
post-Endoscopic Retrograde cholangiopancreatography pancreatitis
Risk factors
Indomethacin
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