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Trial record 21 of 489 for:    pancreatitis

Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02368795
First Posted: February 23, 2015
Last Update Posted: November 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  Purpose

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.


Condition Intervention
Pancreatitis Device: Pancreatic Stent Drug: Indomethacin Drug: Isosorbide Dinitrate Drug: Ringer's lactate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Non-inferiority Trial Comparing Pharmacological Prevention Alone Versus Pancreatic Stents Plus Pharmacological Prevention to Prevent Post-ERCP Pancreatitis

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013) [ Time Frame: One week after ERCP ]
    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)


Estimated Enrollment: 400
Study Start Date: February 2015
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pharmacological Prevention
Combination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic stenting
Drug: Indomethacin
Indomethacin 100 mg suppository ten minutes before ERCP
Drug: Isosorbide Dinitrate
Sublingual Isosorbide dinitrate 5 mg before ERCP
Drug: Ringer's lactate
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.
Active Comparator: Pancreatic Stent
Pancreatic Stent PLUS Pharmacological Prevention
Device: Pancreatic Stent
A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting
Drug: Indomethacin
Indomethacin 100 mg suppository ten minutes before ERCP
Drug: Isosorbide Dinitrate
Sublingual Isosorbide dinitrate 5 mg before ERCP
Drug: Ringer's lactate
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.

  Eligibility

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
  • 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).

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
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): NCT02368795


Contacts
Contact: Rasoul Sotoudehmanesh, MD +989121309240 r.sotoudehmanesh@gmail.com
Contact: Ali Ali Asgari, MD +989123360254 alialiasgari@yahoo.com

Locations
Iran, Islamic Republic of
Shariati hospital Recruiting
Tehran, Iran, Islamic Republic of, 1411713135
Contact: Rasoul sotoudehmanesh, MD    +989121309240    r.sotoudehmanesh@gmail.com   
Contact: Ali Ali Asgari, MD    +989123360254    alialiasgari@yahoo.com   
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02368795     History of Changes
Other Study ID Numbers: 642416
First Submitted: February 2, 2015
First Posted: February 23, 2015
Last Update Posted: November 6, 2015
Last Verified: November 2015

Keywords provided by Tehran University of Medical Sciences:
Endoscopic Retrograde Cholangiopancreatography
Pancreatic duct stenting
Post-ERCP pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
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
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Vasodilator Agents
Nitric Oxide Donors