Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-02 @ 4:11 AM
Study NCT ID:
NCT04228835
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are divided into two arms: ICG enhanced fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-12', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2020-01-12', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to identification of critical view of safety', 'timeFrame': 'Time of surgery', 'description': 'Compare time to identification of critical view of safety during laparoscopic cholecystectomy which is defined as time of gallbladder retraction until establishment of critical view of safety.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'up to 30 days post operative', 'description': 'Compare rate of complications of laparoscopic cholecystectomy such as bile duct injury, major haemorrhage, intraabdominal collections and surgical site infection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Symptomatic and Complicated Cholelithiasis'], 'conditions': ['Cholelithiasis']}, 'referencesModule': {'references': [{'pmid': '23877766', 'type': 'BACKGROUND', 'citation': 'Schols RM, Bouvy ND, van Dam RM, Masclee AA, Dejong CH, Stassen LP. Combined vascular and biliary fluorescence imaging in laparoscopic cholecystectomy. Surg Endosc. 2013 Dec;27(12):4511-7. doi: 10.1007/s00464-013-3100-7. Epub 2013 Jul 23.'}, {'pmid': '25974072', 'type': 'BACKGROUND', 'citation': 'van Dam DA, Ankersmit M, van de Ven P, van Rijswijk AS, Tuynman JB, Meijerink WJ. Comparing Near-Infrared Imaging with Indocyanine Green to Conventional Imaging During Laparoscopic Cholecystectomy: A Prospective Crossover Study. J Laparoendosc Adv Surg Tech A. 2015 Jun;25(6):486-92. doi: 10.1089/lap.2014.0248. Epub 2015 May 14.'}, {'pmid': '33223453', 'type': 'DERIVED', 'citation': 'Koong JK, Ng GH, Ramayah K, Koh PS, Yoong BK. Early identification of the critical view of safety in laparoscopic cholecystectomy using indocyanine green fluorescence cholangiography: A randomised controlled study. Asian J Surg. 2021 Mar;44(3):537-543. doi: 10.1016/j.asjsur.2020.11.002. Epub 2020 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'Achievement of critical view of safety (CVS) is recommended to reduce risk of hilar injury in laparoscopic cholecystectomy. Indocyanine green (ICG) fluorescence cholangiography, a novel technique of real time biliary visualization, is postulated to assist dissection during laparoscopic cholecystectomy (LC). However, its use in providing a faster and safer LC has yet to be established. The main objective of this study is to evaluate whether the use of ICG enhanced fluorescence cholangiography will help in earlier identification critical view of safety during LC.', 'detailedDescription': 'Indocyanine green (ICG) is excreted exclusively in the biliary system and emits fluorescence light when viewed using near infrared imaging. This enables extrahepatic biliary tree anatomy to be delineated during laparoscopic cholecystectomy.\n\nIndocyanine green fluorescence cholangiography also enables earlier detection of cystic duct and common bile duct during laparoscopic cholecystectomy. This is reported in two studies which showed that cystic duct can be identified 11 minutes and 8.6 minutes earlier and common bile duct 10 and 11 minutes earlier than white light imaging.\n\nTo date, there is no data published on the use of fluorescent cholangiography in reducing operative time of identification of critical view of safety during laparoscopic cholecystectomy, which is an integral part of the surgery. Theoretically achievement of critical view of safety maybe facilitated by fluorescent cholangiography as this technique facilitates identification of biliary structures.\n\nThe primary objective of this study is to evaluate whether an earlier identification of CVS can be obtained by using ICG fluorescence cholangiography as an adjunct to conventional laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. Secondary outcomes assessed are the presence of minor or major complications between this two groups.\n\nPatients are randomly assigned into two arms; ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC- LC) and conventional laparoscopic cholecystectomy (LC), using a computer-generated block randomization. Patients in the ICGFC- LC group received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. All the surgeries are performed using standard four ports technique. Near infrared light camera by Karl Storz Endoscopy is used intermittently during dissection for the ICGFC-LC group.\n\nTime to identification of CVS is defined by time of gallbladder retraction to time of establishment of critical view of safety. Critical view of safety is achieved when all the three criteria set by Strasberg is met. Mean time to identification of CVS in the two groups of patients were then compared. All patients are followed up for one month to identify any post-operative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic cholelithiasis for elective cholecystectomy\n* American Society of Anaesthesiologist (ASA) classification of physical status I or II\n* Normal kidney function\n* Normal liver function\n\nExclusion Criteria:\n\n* Liver cirrhosis\n* Hepatits B or C\n* Allergies to iodine or seafood'}, 'identificationModule': {'nctId': 'NCT04228835', 'briefTitle': 'Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Does ICG Fluorescence Cholangiography Identify Critical View of Safety Earlier in Laparoscopic Cholecystectomy: Results From a Randomized Controlled Study in University Malaya Medical Centre', 'orgStudyIdInfo': {'id': '1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICGFC-LC', 'description': "ICG fluorescence cholangiography assisted laparoscopic cholecystectomy (ICGFC-LC) arm patients received intravenous bolus of 2.5mg of ICG before the induction of anaesthesia. Near infrared laparoscopic light camera was utilized intermittently during dissection of Calot's triangle until critical view of safety was achieved.", 'interventionNames': ['Diagnostic Test: Fluorescence Cholangiography']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional LC', 'description': 'Conventional laparoscopic cholecystectomy (LC) arm patients underwent standard white light laparoscopic cholecystectomy without fluorescence cholangiography.'}], 'interventions': [{'name': 'Fluorescence Cholangiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Administration of ICG for fluorescence cholangiography', 'armGroupLabels': ['ICGFC-LC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Jun Kit Koong, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ummi Surgical Sdn Bhd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer and Consultant Surgeon', 'investigatorFullName': 'Dr Koong Jun Kit', 'investigatorAffiliation': 'University of Malaya'}}}}