Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-07 @ 2:03 PM
Study NCT ID:
NCT02368795
Status:
UNKNOWN
Last Update Posted:
2015-11-06
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007548', 'term': 'Isosorbide Dinitrate'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007547', 'term': 'Isosorbide'}, {'id': 'D013012', 'term': 'Sorbitol'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-16', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-ERCP pancreatitis', 'timeFrame': '24 hours after ERCP', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Severity of acute pancreatitis according to revised Atlanta classification (Banks et al. GUT 2013)', 'timeFrame': 'One week after ERCP', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endoscopic Retrograde Cholangiopancreatography', 'Pancreatic duct stenting', 'Post-ERCP pancreatitis'], 'conditions': ['Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '31454851', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nSeveral 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.\n\nSeveral 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).\n\nMost 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 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:\n\nMajor\n\n* Sphincter of Oddi dysfunction.\n* History of previous PEP.\n* Pancreatic injection.\n* Precut sphincterotomy.\n* Balloon sphincter dilation without sphincterotomy.\n* Pancreatic guidewire passages \\> 1.\n\nMinor\n\n* Female patients aged\\<60 years.\n* Nondilated common bile duct (CBD).\n* Normal serum bilirubin (\\<2mg/dl).\n* Failure to clear bile duct stones.\n* Failed cannulation.\n* Difficult cannulation (Time to CBD cannulation more than 10 min or more than five attempts at cannulation).\n\nExclusion Criteria:\n\n* Age younger than 15 years.\n* History of sphincterotomy.\n* Surgically altered anatomy (Billroth II gastrectomy or Roux-en-Y anastomosis).\n* Uncontrolled coagulopathy.\n* Tumor of ampulla of Vater.\n* Those undergoing routine biliary-stent exchange.\n* Acute pancreatitis at the time of ERCP.\n* Chronic pancreatitis.\n* Regular NSAID use during preceding week.\n* Unable to tolerate indomethacin (Creatinine level \\>1.4 mg/dL or active peptic ulcer disease).\n* Unable to tolerate nitrates (closed-angle glaucoma).\n* 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).\n* 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.\n* Known main pancreatic duct stricture toward the head of pancreas.\n* Pregnancy or breastfeeding.\n* Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02368795', 'briefTitle': 'Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Non-inferiority Trial Comparing Pharmacological Prevention Alone Versus Pancreatic Stents Plus Pharmacological Prevention to Prevent Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': '642416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Pharmacological Prevention', 'description': "Combination of rectal indomethacin, sublingual isosorbide dinitrate and intravenous hydration with Ringer's lactate serum without pancreatic stenting", 'interventionNames': ['Drug: Indomethacin', 'Drug: Isosorbide Dinitrate', "Drug: Ringer's lactate"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pancreatic Stent', 'description': 'Pancreatic Stent PLUS Pharmacological Prevention', 'interventionNames': ['Device: Pancreatic Stent', 'Drug: Indomethacin', 'Drug: Isosorbide Dinitrate', "Drug: Ringer's lactate"]}], 'interventions': [{'name': 'Pancreatic Stent', 'type': 'DEVICE', 'description': 'A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting', 'armGroupLabels': ['Pancreatic Stent']}, {'name': 'Indomethacin', 'type': 'DRUG', 'description': 'Indomethacin 100 mg suppository ten minutes before ERCP', 'armGroupLabels': ['Pancreatic Stent', 'Pharmacological Prevention']}, {'name': 'Isosorbide Dinitrate', 'type': 'DRUG', 'description': 'Sublingual Isosorbide dinitrate 5 mg before ERCP', 'armGroupLabels': ['Pancreatic Stent', 'Pharmacological Prevention']}, {'name': "Ringer's lactate", 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Pancreatic Stent', 'Pharmacological Prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1411713135', 'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Rasoul sotoudehmanesh, MD', 'role': 'CONTACT', 'email': 'r.sotoudehmanesh@gmail.com', 'phone': '+989121309240'}, {'name': 'Ali Ali Asgari, MD', 'role': 'CONTACT', 'email': 'alialiasgari@yahoo.com', 'phone': '+989123360254'}], 'facility': 'Shariati hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Rasoul Sotoudehmanesh, MD', 'role': 'CONTACT', 'email': 'r.sotoudehmanesh@gmail.com', 'phone': '+989121309240'}, {'name': 'Ali Ali Asgari, MD', 'role': 'CONTACT', 'email': 'alialiasgari@yahoo.com', 'phone': '+989123360254'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}