Post-ERCP Acute Pancreatitis.Phase 1NCT01946984
Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis
A Phase 1 study testing ERCP, Diclofenac hydroxyethylpyrrolidine and Normal Saline in people with Post-ERCP Acute Pancreatitis., run by Specialized Arab Hospital at 1 site in Palestinian Territories.
Trial summary
1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis. 2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo. 3. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis.
- What is being tested?
- ERCP, Diclofenac hydroxyethylpyrrolidine and Normal Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- Jun 2012to Jun 2013
- Phase
- Phase 1
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any patient above the age of 16, referred for ERCP
Who cannot join
- 1.could not reach the ampulla due to: A. Pyloric stenosis B. Ampullary tumor C. Diverticula 2. ERCP done recently 3. Stent replacement 4. Congestive Heart Failure(CHF) 5. Asthma
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
SAH hospital
Nablus, West Bank, 970
About this study
Official title: Intramuscular Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial, In Post ERCP Pancreatitis.
- The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
- Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
- The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
- The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.
Read the detailed description
- All patients signed informed consents for the procedure, and the participation in the study.
- Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
- Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
- A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
- Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:
- the total time of the procedure,
- the number of attempts at cannulation,
- the number of pancreatic duct cannulation,
- the final diagnosis by ERCP,
- whether a sphincterotomy, a needle-knife papillotomy, or stent placement were performed.
- Serum amylase was determined 12 hours after ERCP.
- If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
- Acute pancreatitis was defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
- Statistical analysis:
- Randomization was done by the GI nurse, concealed envelop
- Data were summarized by descriptive statistics.
- The Chi square was used to compare categorical patient data.
- The Student's t test was used to compare continuous variables.
- Two-tailed P < 0.05 was considered to indicate significance.
- Conditions
- Post-ERCP Acute Pancreatitis.
- Being tested
- ERCP, Diclofenac hydroxyethylpyrrolidine, Normal Saline
- Keywords
- diclofenac, ERCP and pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
endoscopy, retrograde cholangio-pancreaticography.
Diclofenac hydroxyethylpyrrolidineDrug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac,75 mg, 3 ml, | Active comparator | patients were given Diclofenac IM before ERCP. Receives: Procedure: ERCP; Drug: Diclofenac hydroxyethylpyrrolidine |
| Normal Saline, 3ml, IM | Placebo comparator | patients were given normal saline 3 ml before ERCP Receives: Procedure: ERCP; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of pancreatitis,
- Patients with epigastric pain, back pain, and epigastric tenderness,
- And all had serum amylase measured after the procedure, if elevated more than 3 folds of normal, the patient was diagnosed to have post ERCP pancreatitis,
Measured: within a week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute Pancreatitis.Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Specialized Arab Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Abu-Safieh, Specialized Arab Hospital
- Investigators
- Yasser Abu-Safieh, MD, AGAF, Principal investigator, Specialized Arab Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946984
- Sponsor's protocol ID
- Specialized Arab Hospital
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial, In Post ERCP Pancreatitis.
- ClinicalTrials.gov ID
- NCT01946984
- Acronym / sponsor ID
- Specialized Arab Hospital
- Conditions
- Post-ERCP Acute Pancreatitis.
- Keywords
- diclofenac, ERCP and pancreatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Specialized Arab HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Sep 2013 (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.
- The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
- Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
- The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
- The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.
Detailed description
- All patients signed informed consents for the procedure, and the participation in the study.
- Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
- Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
- A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
- Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:
- the total time of the procedure,
- the number of attempts at cannulation,
- the number of pancreatic duct cannulation,
- the final diagnosis by ERCP,
- whether a sphincterotomy, a needle-knife papillotomy, or stent placement were performed.
- Serum amylase was determined 12 hours after ERCP.
- If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
- Acute pancreatitis was defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
- Statistical analysis:
- Randomization was done by the GI nurse, concealed envelop
- Data were summarized by descriptive statistics.
- The Chi square was used to compare categorical patient data.
- The Student's t test was used to compare continuous variables.
- Two-tailed P < 0.05 was considered to indicate significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac,75 mg, 3 ml, | Active comparator | Procedure: ERCP, Drug: Diclofenac hydroxyethylpyrrolidinepatients were given Diclofenac IM before ERCP. |
| Normal Saline, 3ml, IM | Placebo comparator | Procedure: ERCP, Drug: Normal Salinepatients were given normal saline 3 ml before ERCP |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any patient above the age of 16, referred for ERCP
Key exclusion criteria (1 listed)
- 1.could not reach the ampulla due to: A. Pyloric stenosis B. Ampullary tumor C. Diverticula 2. ERCP done recently 3. Stent replacement 4. Congestive Heart Failure(CHF) 5. Asthma
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 |
|---|---|---|
| ERCPendoscopy, retrograde cholangio-pancreaticography. | Procedure or surgery | Diclofenac,75 mg, 3 ml,, Normal Saline, 3ml, IM |
| Diclofenac hydroxyethylpyrrolidine | Drug | Diclofenac,75 mg, 3 ml, |
| Normal Saline | Drug | Normal Saline, 3ml, IM |
Primary outcome
prevention of pancreatitis,
Time frame: within a week after procedure
1. Patients with epigastric pain, back pain, and epigastric tenderness, 2. And all had serum amylase measured after the procedure, if elevated more than 3 folds of normal, the patient was diagnosed to have post ERCP pancreatitis,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
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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.
Yasser Abu-Safieh, MD, AGAF principal investigator
Specialized Arab Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERCP, Diclofenac hydroxyethylpyrrolidine and Normal Saline in people with Post-ERCP Acute Pancreatitis., run by Specialized Arab Hospital at 1 site in Palestinian Territories.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Sep 2013. 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 Palestinian Territories. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevention of pancreatitis, (time frame: within a week after procedure). 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 20 Sep 2013; AzTrials last refreshed its copy on 31 Oct 2026.