Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-04 @ 3:58 PM
Study NCT ID:
NCT04671095
Status:
COMPLETED
Last Update Posted:
2023-09-05
First Post:
2020-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Use ERCP Performance -SURE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D002761', 'term': 'Cholangitis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'completion of the intended ERCP procedure with single use duodenoscope.', 'timeFrame': '60-120 minutes', 'description': 'To assess if the intended ERCP prcodure can be successfully completed with single use disposable duodenoscope.'}], 'secondaryOutcomes': [{'measure': 'Rate of complications', 'timeFrame': '30 days post procedure', 'description': 'Complications associated with the procedure such as bleeding, pancreatitis, post-ERCP infection and perforation'}, {'measure': 'EQ-5D-5L quality of life questionnaire', 'timeFrame': '30 days', 'description': 'Quality of life of patients following procedure (EQ-5D-5L questionnaire) This is a descriptive system comprises the following five dimensions, each describ- ing a different aspect of health:mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels: 1=no problem, 2=moderate problem, 3=severe problem'}, {'measure': 'Endoscopy metrics associated with the procedure', 'timeFrame': 'During the procedure', 'description': '1\\. Time to complete procedure, ease of intubation, ease of intubating duodenum, number of attempts to cannulate CBD'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['EXALT', 'Single use duodenoscope', 'ERCP'], 'conditions': ['ERCP', 'Infection', 'Cholangitis']}, 'descriptionModule': {'briefSummary': 'We do ERCP procedure (Endoscopic procedure with the help of x-rays) for a variety of reasons such as bile duct stones, bile duct obstruction secondary to bile duct narrowing (Strictures) and for bile leak. The incidence of infection post ERCP is around one in 200. There are some group of patients where this risk is significantly increased. In this high risk group, the risk increases from 1 in 75 to in some diseases 1 in 15 (Described in PIS).\n\nThere are some reports that some of the infection may be contributed by contamination of bacteria in the scope. This happens even after diligently sterilizing the scope. A multi-centre study reported that the risk of contamination is as high as 39% but what we do not know is how many resulted in bacterial infection. We do not know what percentage of infection is secondary to the above. The new single use duodenoscope has been introduced in to the market to minimise the risk of post ERCP infection. It is CE marked and a single centre study reported that the above performance of the above scope was comparable to the standard reusable scope. We want to assess the scope simultaneously in multiple different hospitals. In addition, we also want to assess the cost consequence to the NHS for using the above scope. Hence we want to assess the performance of the scope in the high risk groups for infection.', 'detailedDescription': 'ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both. The indications for ERCP are bile duct stones, bile duct strictures, sphincter of Oddi manometry with sphincterotomy, bile leak, pancreatic duct stones and pancreatic duct stricture. The intended benefits of the procedure are either to relieve bile duct/ pancreatic duct obstruction or facilitate bile duct/ pancreatic duct drainage. It is a minimally invasive procedure and is associated with reduced morbidity compared to surgery.\n\nGall stones are made of cholesterol, pigment and mixture of cholesterol and pigment. The incidence of stones with in the bile-duct varies from 4.6% to 19%.The stones are predominantly formed in the gall bladder and are displaced from the gall bladder in to the bile duct via the cystic duct. ERCP is an effective and minimally invasive treatment for bile duct stones. Treatment of extra- hepatic biliary strictures; irrespective of their aetiology, is to place a stent across the stricture through ERCP and facilitate biliary drainage.\n\nThere is emerging data that the incidence of carbapenem resistant enterobacteriae, Multidrug-resistant Klebsiella pneumoniae, and New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli (CRE) following exposure to contaminated duodenoscopes (ERCP endoscopes). The main reason for the outbreaks is due to inadequate reprocessing (Cleaning of endoscope post procedure) leading to contamination of endoscpes.\n\nTo minimise the risk of contamination and outbreak of above infections, single use disposable duodenoscopes have been brought in to the market. The aim of the study is to assess the performance of the single use duodenoscope against the standard reusable duodenoscope and the cost consequences associated with the above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population studied will be patients who need ERCP procedure. All consecutive patients who are referred for ERCP will be screened to see if they meet the eligibility criteria to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Patients who are at high risk of post ERCP infection such as\n\n * Jaundice (Bilirubin \\>21)\n * Primary sclerosing cholangitis\n * Post liver transplant anastomotic stricture\n * Inpatients\n * Combined procedures (Ex: ERCP+ spy glass cholangioscopy)\n * Previous inadequate biliary drainage.\n * Biliary stricture\n\n * Participant is willing and able to give informed consent for participation in the study.\n * Male or Female, aged 18 years or above.\n * Grade 1-3 ERCP on complexity grading (ASGE grading)\n * Able (in the Investigators opinion) and willing to comply with all study requirements.\n * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.\n\nExclusion Criteria:\n\n* Patients with CBD stones and no jaundice\n\n * Sphincter of Oddi manometry.\n * Female participants who is pregnant, lactating or planning pregnancy during the course of the study.\n * Patients who are unable to consent for the study.\n * ERCP for Pancreatic pathology.\n * Grade 4 complex ERCP (ASGE grading)\n * Participant who is terminally ill /ECOG 4\n * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT04671095', 'acronym': 'SURE', 'briefTitle': 'Single Use ERCP Performance -SURE Study', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': 'Prospective Observational Cohort Study: To Assess the Performance of Single Use Duodenoscope', 'orgStudyIdInfo': {'id': '20GA082'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ERCP procedure with single use duodenoscope', 'type': 'DEVICE', 'otherNames': ['ERCP procedure with Single use disposable duodenoscope'], 'description': 'ERCP is an endoscopic procedure done to relieve bile duct obstruction. It is done either under conscious sedation or deep sedation. The endoscope is inserted thorough the mouth and is taken to the second part of duodenum (small bowel). The ampulla is identified and the bile duct is cannulated. Biliary obstruction is relieved either by placing a stent or removing the stone/s'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Suresh Vasan Venkatachalapathy, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}