An interventional study of Laparoscopic Cholecystectomy with Fluorescent Cholangiography and Laparoscopic Cholecystectomy with White Light Imaging in Cholecystitis, Acute, Acute Cholangitis and Gallstone Pancreatitis, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-15.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Participants will be randomized into either the control arm, which uses the standard of care white light during laparoscopy or the intervention arm, which will use ICG fluorescent cholangiography as an adjunct to white light to visualize the biliary anatomy. The investigators hypothesize that the use of fluorescent cholangiography will increase the rates of identification of important biliary anatomy during laparoscopic cholecystectomy. The effectiveness, feasibility, and safety will be compared between the two groups using a post-operative survey form the surgeons will complete prior to exiting the operating room.
Near-infrared fluorescent imaging techniques have shown promise in aiding to delineate and visualize extrahepatic biliary structures. Indocyanine green (ICG) is a water-soluble fluorescent dye that has been shown to improve visualization of biliary anatomy under fluorescent cholangiography. The standard of care for many acute biliary disease conditions, such as acute cholecystitis, remains early laparoscopic cholecystectomy. Even though real-time fluorescent cholangiography using ICG has the potential to enhance the visualization of biliary structures and anatomy, and therefore reduce the risk for bile duct injury, the majority of the studies published to date exclude acute biliary disease patients. The pathophysiology of acute biliary disease processes is associated with inflammation and adhesions that increase the challenge of achieving a critical view of safety. The investigators propose that using ICG and fluorescent cholangiography near-infrared imaging techniques as an adjunct in acute care laparoscopic cholecystectomies has the potential to help mitigate the increased risk of bile duct injury by increasing extrahepatic biliary structure detection and surgeon confidence.
Eligible patients will be identified through their initial clinical evaluation, which will be verified by the patient's primary surgeon. If and once a patient has been confirmed as eligible, the surgeon or designate will introduce the clinical trial design in detail. If after being introduced to the study and having had the opportunity to ask questions, the patient is willing to participate, the patient will be asked to review and sign the informed consent document.
Upon entry into the clinical trial, the allocation sequence will be generated using a block randomization schema with computer-generated random numbers in a 1:1 ratio, with block sizes of 4 by a co-investigator with no clinical involvement in the trial. The same co-investigator will prepare sequentially numbered, opaque, sealed and stapled envelopes and stored them in a locked cabinet in the operating room control desk. Each envelope contained instructions for the arm the participant had been randomly assigned to, either treatment (ICG cholangiography) or control (standard white light only) arms. After the research team member has obtained the participant's consent, the surgeon or designates will obtain the next consecutively numbered envelope and proceed to open it after the patient is anesthetized and prior to beginning the surgery.
The patient will be blinded to the result of the randomization until after surgery as the envelope will be opened only after the patient has received their general anesthetic. No blinding of the surgical team, research team members or outcomes assessors will be used in this study given the procedural nature and acute condition of the patients included.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's planned enrollment of 340 is above the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard laparoscopic cholecystectomy completed with a combination of white light imaging and near-Infrared fluorescence cholangiography after administering 5 mg of a 25 mg/10 mL solution of indocyanine green (ICG) intravenously prior to the operation
Procedure: Laparoscopic Cholecystectomy with Fluorescent Cholangiography · Procedure: Laparoscopic Cholecystectomy with White Light Imaging
Standard laparoscopic cholecystectomy completed with only standard white light imaging only
Procedure: Laparoscopic Cholecystectomy with White Light Imaging
Indocyanine green is a fluorophore molecule which is metabolized by the liver and excreted exclusively through the biliary system. Intra-operatively, near-infared imaging via the laparoscope will be used to visualize the biliary anatomy in the intervention arm, as an adjunct to standard of care white-light imaging.
As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.
Detection rate of extrahepatic biliary structures
The extrahepatic biliary structures which we will be assessing the identification of include: Cystic Duct (CD), Right Hepatic Duct (RHD), Common Hepatic Duct (CHD), Common Bile Duct (CBD), Cystic Duct - Gall Bladder junction (CD-GB), and Cystic Duct - Common Bile Duct junction (CD-CBD).
Time frame: Intraoperatively
Operative success
Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.
Time frame: Intraoperatively
Rates of conversion
Rate of conversion to open cholecystectomy.
Time frame: Intraoperatively
Operative time
From the time of opening the skin to the time of closure.
Time frame: Intraoperatively
Surgeon satisfaction
Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.
Time frame: Through participant discharge, an average of 1 week
Adverse events
Any adverse events associated with the administration or use of ICG fluorescent cholangiography
Time frame: Through participant discharge, an average of 1 week
Procedural complications
Any complications associated with the cholecystectomy
Time frame: Through participant discharge, an average of 1 week
Plan to share: No
Start is estimated for Aug 2021; primary completion for Dec 2022, 16 months later.
Of 42 non-industry interventional studies with no phase under Cholecystitis, Acute, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 16 months is below that.
Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 9 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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