PancreatitisNCT02368795
Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis
A study testing Pancreatic Stent, Indomethacin and Isosorbide Dinitrate in people with Pancreatitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Pancreatitis is the most important complication of ERCP. The severity of this condition varies from mild to severe and can lead to prolonged hospitalization, surgical interventions, and even death. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Pancreatic Stent, Indomethacin and Isosorbide Dinitrate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteIran
- Study dates
- Feb 2015to Jan 2017
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients at high risk of post-ERCP Pancreatitis undergoing ERCP are eligible to enter the study. At least one major or two minor criteria must be present for the patient to be considered at high risk for PEP:
- Major
- Sphincter of Oddi dysfunction.
- History of previous PEP.
- Pancreatic injection.
- Precut sphincterotomy.
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- Balloon sphincter dilation without sphincterotomy.
- Pancreatic guidewire passages > 1.
- Minor
- Female patients aged<60 years.
- Nondilated common bile duct (CBD).
- Normal serum bilirubin (<2mg/dl).
- Failure to clear bile duct stones.
- Failed cannulation.
- Difficult cannulation (Time to CBD cannulation more than 10 min or more than five attempts at cannulation).
Who cannot join
- Age younger than 15 years.
- History of sphincterotomy.
- Surgically altered anatomy (Billroth II gastrectomy or Roux-en-Y anastomosis).
- Uncontrolled coagulopathy.
- Tumor of ampulla of Vater.
- Those undergoing routine biliary-stent exchange.
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- Acute pancreatitis at the time of ERCP.
- Chronic pancreatitis.
- Regular NSAID use during preceding week.
- Unable to tolerate indomethacin (Creatinine level >1.4 mg/dL or active peptic ulcer disease).
- Unable to tolerate nitrates (closed-angle glaucoma).
- Unable to tolerate aggressive hydration (cardiac insufficiency: NYHA FC II or higher, renal insufficiency, electrolyte disturbances, clinical signs of fluid overload including peripheral or pulmonary edema, liver dysfunction with varix>F1, or respiratory insufficiency).
- Patients requiring pancreatic duct drainage: to bridge dominant strictures, bypass obstructing pancreatic duct stones, drain pseudocysts, seal duct disruptions, pancreatic head cancer with main PD obstruction, IPMN or Pancreas divisum.
- Known main pancreatic duct stricture toward the head of pancreas.
- Pregnancy or breastfeeding.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shariati hospital
Tehran, Tehran Province, 1411713135
Rasoul sotoudehmanesh, MD, +989121309240, r.sotoudehmanesh@gmail.com
Ali Ali Asgari, MD, +989123360254, alialiasgari@yahoo.com
About this study
Official title: Non-inferiority Trial Comparing Pharmacological Prevention Alone Versus Pancreatic Stents Plus Pharmacological Prevention to Prevent Post-ERCP Pancreatitis
Pancreatitis is the most important complication of ERCP. The severity of this condition varies from mild to severe and can lead to prolonged hospitalization, surgical interventions, and even death. Several patient-related and procedure related factors have been identified that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods have been proposed to avoid pancreatitis in patients at higher risk of this complication.
Several studies have shown that different drug therapies (indomethacin suppository, a sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and easy to administer.
Read more
Several other studies have shown that pancreatic duct stenting (placement of a plastic tube in the pancreatic duct) is an effective intervention in preventing and reducing the severity of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few drawbacks to consider with pancreatic duct stenting: there are some difficulties with insertion of a PD stent, it is associated with a need for radiological follow-up and/or repeat endoscopy for removal, higher cost and a small but important risk of complications (e.g. stent migration).
Most of the clinical trials of pancreatic duct stenting were performed, before the results of trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge) has compared the efficacy of pancreatic duct stenting in patients who already received a combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The purpose of this study is to determine the noninferiority of a combination of drug therapies in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk patients.
- Conditions
- Pancreatitis
- Being tested
- Pancreatic Stent, Indomethacin, Isosorbide Dinitrate, Ringer's lactate
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Pancreatic duct stenting, Post-ERCP pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic StentDevice
A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting
IndomethacinDrug
Indomethacin 100 mg suppository ten minutes before ERCP
Isosorbide DinitrateDrug
Sublingual Isosorbide dinitrate 5 mg before ERCP
Ringer's lactateDrug
IV Ringer's lactate serum with a dose of 6 cc/kg/h during the procedure and 20 cc/kg after ERCP as a bolus dose and 3 cc/kg/h for the next 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological Prevention | Placebo comparator | Combination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic stenting Receives: Drug: Indomethacin; Drug: Isosorbide Dinitrate; Drug: Ringer's lactate |
| Pancreatic Stent | Active comparator | Pancreatic Stent PLUS Pharmacological Prevention Receives: Device: Pancreatic Stent; Drug: Indomethacin; Drug: Isosorbide Dinitrate; Drug: Ringer's lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP pancreatitis
Pancreatitis is defined as new or worsened abdominal pain and tenderness with amylase levels at least three times above the upper limit of normal at 24 hours after the procedure, requiring hospital admission or a prolongation of planned admission.
Measured: 24 hours after ERCP
Secondary outcomes (1)
Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013)
Mild acute pancreatitis (No organ failure, No local or systemic complications) Moderately severe acute pancreatitis (transient organ failure that resolves within 48 h and/or Local or systemic complications without persistent organ failure) Severe acute pancreatitis (Persistent organ failure >48 h)
Measured: One week after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368795
- Sponsor's protocol ID
- 642416
- Status last verified
- Nov 2015
- First submitted
- 2 Feb 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sotoudehmanesh R, Ali-Asgari A, Khatibian M, Mohamadnejad M, Merat S, Sadeghi A, Keshtkar A, Bagheri M, Delavari A, Amani M, Vahedi H, Nasseri-Moghaddam S, Sima A, Eloubeidi MA, Malekzadeh R. Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial. Endoscopy. 2019 Oct;51(10):915-921. doi: 10.1055/a-0977-3119. Epub 2019 Aug 27.
PubMed 31454851
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Trial Comparing Pharmacological Prevention Alone Versus Pancreatic Stents Plus Pharmacological Prevention to Prevent Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT02368795
- Acronym / sponsor ID
- 642416
- Conditions
- Pancreatitis
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Pancreatic duct stenting, Post-ERCP pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 23 Feb 2015 (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.
Pancreatitis is the most important complication of ERCP. The severity of this condition varies from mild to severe and can lead to prolonged hospitalization, surgical interventions, and even death. Several patient-related and procedure related factors have been identified that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods have been proposed to avoid pancreatitis in patients at higher risk of this complication.
Several studies have shown that different drug therapies (indomethacin suppository, a sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and easy to administer.
Several other studies have shown that pancreatic duct stenting (placement of a plastic tube in the pancreatic duct) is an effective intervention in preventing and reducing the severity of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few drawbacks to consider with pancreatic duct stenting: there are some difficulties with insertion of a PD stent, it is associated with a need for radiological follow-up and/or repeat endoscopy for removal, higher cost and a small but important risk of complications (e.g. stent migration).
Most of the clinical trials of pancreatic duct stenting were performed, before the results of trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge) has compared the efficacy of pancreatic duct stenting in patients who already received a combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The purpose of this study is to determine the noninferiority of a combination of drug therapies in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacological Prevention | Placebo comparator | Drug: Indomethacin, Drug: Isosorbide Dinitrate, Drug: Ringer's lactateCombination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic stenting |
| Pancreatic Stent | Active comparator | Device: Pancreatic Stent, Drug: Indomethacin, Drug: Isosorbide Dinitrate, Drug: Ringer's lactatePancreatic Stent PLUS Pharmacological Prevention |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients at high risk of post-ERCP Pancreatitis undergoing ERCP are eligible to enter the study. At least one major or two minor criteria must be present for the patient to be considered at high risk for PEP:
- Major
- Sphincter of Oddi dysfunction.
- History of previous PEP.
- Pancreatic injection.
Key exclusion criteria (16 listed)
- Age younger than 15 years.
- History of sphincterotomy.
- Surgically altered anatomy (Billroth II gastrectomy or Roux-en-Y anastomosis).
- Uncontrolled coagulopathy.
- Tumor of ampulla of Vater.
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 |
|---|---|---|
| Pancreatic StentA 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting | Device | Pancreatic Stent |
| IndomethacinIndomethacin 100 mg suppository ten minutes before ERCP | Drug | Pancreatic Stent, Pharmacological Prevention |
| Isosorbide DinitrateSublingual Isosorbide dinitrate 5 mg before ERCP | Drug | Pancreatic Stent, Pharmacological Prevention |
| Ringer's lactateIV Ringer's lactate serum with a dose of 6 cc/kg/h during the procedure and 20 cc/kg after ERCP as a bolus dose and 3 cc/kg/h for the next 8 hours. | Drug | Pancreatic Stent, Pharmacological Prevention |
Primary outcome
Post-ERCP pancreatitis
Time frame: 24 hours after ERCP
Pancreatitis is defined as new or worsened abdominal pain and tenderness with amylase levels at least three times above the upper limit of normal at 24 hours after the procedure, requiring hospital admission or a prolongation of planned admission.
1 secondary outcome
Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013)
Time frame: One week after ERCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Derived from this study: PubMed 31454851Sotoudehmanesh R, Ali-Asgari A, Khatibian M, Mohamadnejad M, Merat S, Sadeghi A, Keshtkar A, Bagheri M, Delavari A, Amani M, Vahedi H, Nasseri-Moghaddam S, Sima A, Eloubeidi MA, Malekzadeh R. Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial. Endoscopy. 2019 Oct;51(10):915-921. doi: 10.1055/a-0977-3119. Epub 2019 Aug 27.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic Stent, Indomethacin and Isosorbide Dinitrate in people with Pancreatitis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 15 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 6 Nov 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 Iran. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasoul Sotoudehmanesh, MD (+989121309240, r.sotoudehmanesh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-ERCP pancreatitis (time frame: 24 hours after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368795, which also lists 1 linked publication.
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 6 Nov 2015.