Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428025
Status:
TERMINATED
Last Update Posted:
2015-09-22
First Post:
2007-01-25
Brief Title:
Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients A Prospective Randomized Double Blind Placebo Controlled Trial
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inflammation of the pancreas pancreatitis is an uncommon but potentially serious complication of endoscopic retrograde cholangiopancreatography ERCP a specialized endoscopic examination of the ducts draining the liver and pancreas Although many different strategies have been tried and studied in attempts to reduce this risk few have been shown to make a significant difference Those that have are either very expensive difficult to administer or both
Diclofenac an anti-inflammatory medication most often used to treat arthritis has shown potential to decrease the risk of post-ERCP pancreatitis It can be given after the procedure to patients at most risk for the complication and has few side effects This study will randomize people in the study to placebo or active medication to determine if Diclofenac reduces the incidence of pancreatitis
Diclofenac an anti-inflammatory medication most often used to treat arthritis has shown potential to decrease the risk of post-ERCP pancreatitis It can be given after the procedure to patients at most risk for the complication and has few side effects This study will randomize people in the study to placebo or active medication to determine if Diclofenac reduces the incidence of pancreatitis
Detailed Description:
Hypothesis
Diclofenac when administered immediately post ERCP in patients at higher risk of developing post-ERCP pancreatitis will significantly reduce the incidence of this complication
Intervention
All patients undergoing ERCP not having exclusion criteria will be approached for participation prior to the procedure At the end of the procedure prior to transfer from the endoscopy suite within 15 minutes of the end of the procedure if the patient meets inclusion criteria a study suppository will be administered
The suppositories will be prepared by a study pharmacist according to a randomization list prepared by an independent biostatistician They will be randomized using a permuted block design in blocks of 20 The placebo is inert and identical to the study medication a 100 mg diclofenac rectal suppository The code will not be broken until enrolment of patients is complete
Patients endoscopists nurses and the principal investigator will all be blinded to the randomization code
Outcomes
Post-ERCP acute pancreatitis is the primary outcome Consensus definition of this is new typical epigastricretroperitoneal pain combined with an elevation of serum lipase or amylase 3 times the upper limit of normal Pain will be assessed through history and physical exam by an attending gastroenterologist the morning after the procedure with documentation in the chart and research form of the presence or absence of pain Serum amylase will be measured the morning after the procedure between 7 and 10 am approximately 18 hours post procedure Most patients will be inpatients but outpatients will be included if they can be assessed through clinical exam and blood chemistry analysis the following morning Patients will be contacted one week after the procedure to ensure no episode of abdominal pain or bleeding has been missed
Statistics and Power Calculation
A two sided Fishers Exact Test will be used to compare the proportion of patients developing post-ERCP pancreatitis in each group placebo vs active drug
In the population selected the estimated risk of pancreatitis is 15 To demonstrate a decrease to 5 141 patients will be required in each group with 80 power and an alpha error 005 Secondary outcomes will include severity of pancreatitis hyperamylasemia length of stay and mortality Safety data regarding renal function and GI bleeding will also be collected
Diclofenac when administered immediately post ERCP in patients at higher risk of developing post-ERCP pancreatitis will significantly reduce the incidence of this complication
Intervention
All patients undergoing ERCP not having exclusion criteria will be approached for participation prior to the procedure At the end of the procedure prior to transfer from the endoscopy suite within 15 minutes of the end of the procedure if the patient meets inclusion criteria a study suppository will be administered
The suppositories will be prepared by a study pharmacist according to a randomization list prepared by an independent biostatistician They will be randomized using a permuted block design in blocks of 20 The placebo is inert and identical to the study medication a 100 mg diclofenac rectal suppository The code will not be broken until enrolment of patients is complete
Patients endoscopists nurses and the principal investigator will all be blinded to the randomization code
Outcomes
Post-ERCP acute pancreatitis is the primary outcome Consensus definition of this is new typical epigastricretroperitoneal pain combined with an elevation of serum lipase or amylase 3 times the upper limit of normal Pain will be assessed through history and physical exam by an attending gastroenterologist the morning after the procedure with documentation in the chart and research form of the presence or absence of pain Serum amylase will be measured the morning after the procedure between 7 and 10 am approximately 18 hours post procedure Most patients will be inpatients but outpatients will be included if they can be assessed through clinical exam and blood chemistry analysis the following morning Patients will be contacted one week after the procedure to ensure no episode of abdominal pain or bleeding has been missed
Statistics and Power Calculation
A two sided Fishers Exact Test will be used to compare the proportion of patients developing post-ERCP pancreatitis in each group placebo vs active drug
In the population selected the estimated risk of pancreatitis is 15 To demonstrate a decrease to 5 141 patients will be required in each group with 80 power and an alpha error 005 Secondary outcomes will include severity of pancreatitis hyperamylasemia length of stay and mortality Safety data regarding renal function and GI bleeding will also be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None