Trial record 19 of 351 for:    pancreatitis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02368795
First received: February 2, 2015
Last updated: April 6, 2015
Last verified: April 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02368795     History of Changes
Other Study ID Numbers: 642416
Study First Received: February 2, 2015
Last Updated: April 6, 2015
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Indomethacin
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Diuretics
Diuretics, Osmotic
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Nitric Oxide Donors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 27, 2015