PancreatitisPhase 4NCT00428025
Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
A Phase 4 study testing diclofenac in people with Pancreatitis, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- These were chosen based on a review of the major studies evaluating risk factors for post-ERCP pancreatitis. Any of the following factors placing a patient at high risk (>10%) of post ERCP pancreatitis:
- Patient characteristics: Prior history of post-ERCP pancreatitis, prior history of acute pancreatitis, suspected Sphincter of Oddi dysfunction, or normal bilirubin;
- Procedure related factors: Moderate (6-15 attempts) and difficult (>15 attempts) bile duct cannulation, balloon dilation of the biliary sphincter, pre-cut papillotomy, pancreatic sphincterotomy.
Who cannot join
- Ongoing acute or chronic pancreatitis;
- Previous biliary sphincterotomy;
- Contra-indications to non-steroidal anti-inflammatory medications (allergy, reduced renal function, recent upper gastrointestinal bleeding);
- Ingestion of an NSAID ( nonsteroidal anti-inflammatory drug) in the previous 7 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients: A Prospective, Randomized, Double Blind, Placebo Controlled Trial.
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.
Read the 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 (epigastric/retroperitoneal) 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 Fisher's 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 0.05. 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.
- Conditions
- Pancreatitis
- Being tested
- diclofenac, placebo
- Keywords
- pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenacDrug
100 mg diclofenac rectal suppository
placeboDrug
similar shape and size suppository
| Study group | Role | What they receive |
|---|---|---|
| placebo suppository | Placebo comparator | Not described Receives: Drug: placebo |
| diclofenac suppository | Active comparator | Not described Receives: Drug: diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-ercp pancreatitis
Measured: 24 hours
Secondary outcomes (1)
severity of pancreatitis, side effects
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428025
- Sponsor's protocol ID
- diclofenac trial hookey
- Status last verified
- Sep 2015
- First submitted
- 25 Jan 2007
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients: A Prospective, Randomized, Double Blind, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00428025
- Acronym / sponsor ID
- diclofenac trial hookey
- Conditions
- Pancreatitis
- Keywords
- pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (epigastric/retroperitoneal) 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 Fisher's 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 0.05. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo suppository | Placebo comparator | Drug: placebo |
| diclofenac suppository | Active comparator | Drug: diclofenac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- These were chosen based on a review of the major studies evaluating risk factors for post-ERCP pancreatitis. Any of the following factors placing a patient at high risk (>10%) of post ERCP pancreatitis:
- Patient characteristics: Prior history of post-ERCP pancreatitis, prior history of acute pancreatitis, suspected Sphincter of Oddi dysfunction, or normal bilirubin;
- Procedure related factors: Moderate (6-15 attempts) and difficult (>15 attempts) bile duct cannulation, balloon dilation of the biliary sphincter, pre-cut papillotomy, pancreatic sphincterotomy.
Key exclusion criteria (4 listed)
- Ongoing acute or chronic pancreatitis;
- Previous biliary sphincterotomy;
- Contra-indications to non-steroidal anti-inflammatory medications (allergy, reduced renal function, recent upper gastrointestinal bleeding);
- Ingestion of an NSAID ( nonsteroidal anti-inflammatory drug) in the previous 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diclofenac100 mg diclofenac rectal suppository | Drug | diclofenac suppository |
| placebosimilar shape and size suppository | Drug | placebo suppository |
Primary outcome
post-ercp pancreatitis
Time frame: 24 hours
1 secondary outcome
severity of pancreatitis, side effects
Time frame: 30 days
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Hookey, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diclofenac in people with Pancreatitis, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-ercp pancreatitis (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.