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| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
| Tokyo Medical University | OTHER |
| Asklepios Kliniken Hamburg GmbH | OTHER |
| Università degli Studi dell'Insubria |
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The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs better than standard white light (WLI) alone in visualizing and identifying extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before and after dissection during Laparoscopic Cholecystectomy (LC).
Recently, a novel technique to visualize structures using fluorescent light and intravenous dye has been developed.
Near Infrared Incisionless Fluorescent Cholangiography (NIFC) is a medical imaging technique that uses fluorescence to detect properly labeled structures during surgery.
NIFC is performed using imaging devices with the purpose of providing real-time simultaneous information from color reflectance images (white light) and fluorescence emission (near infrared light). One or more light sources are used to excite and illuminate the sample. Light is collected using optical filters that match the emission spectrum of the fluorophore. Imaging lenses and digital cameras are used to produce the final image.
During laparoscopic cholecystectomies, the visualization of the extra-hepatic bile ducts with fluorescence is called Near Infrared Incisionless Fluorescent Cholangiography (NIFC). Fluorescence equipment and a dye are necessary in order to perform a NIFC, but the technique requires no radiation or incision. A fluorescence dye is administrated intravenously at least 45 minutes before the surgery, which is excreted by the liver and the bile duct The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during laparoscopic cholecystectomy.
Eligible patients will be identified through clinical and test evaluation. Eligibility will be verified by the patient's primary surgeon. The surgeon will determine the indication and date of the surgery. Once a patient is confirmed as eligible, the surgeon will introduce the study in detail. If after being introduced to the study and having had the opportunity to ask questions, the patient is willing to participate, he/she will be asked to review and sign the informed consent document .
Upon entry in the clinical trial patients will be randomly allocated to the intervention arm. Data will be collected at enrolment time, during surgery, at the end of surgery and one week after surgery.
Upon entry in the clinical trial, the master study database (REDCap, will randomly allocated patients to one of the study arms (1:1) within site (1:1) using a computer generated random sequence. This will provide an allocation sequence for each site. Once a patient is enrolled and a database file in REDCap is initiated for that patient, he/she will be assigned electronically to one of the study arms.
Patient will be blind to the intervention but surgeon blinding will not be feasible due to the nature of the intervention. The study will involve a considerable number of surgeons in each site, which should compensate any potential bias of some of them in favor or against either approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon Light | Active Comparator | Laparoscopic cholecystectomy with Xenon Light |
|
| Near infrared light | Experimental | Laparoscopic cholecystectomy with Near infrared light |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy with Xenon light | Procedure | Standard laparoscopic cholecystectomy with white light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light | Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification. | Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Rosenthal, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedar Sinai | Los Angeles | California | 90048 | United States | ||
| Cleveland Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30614881 | Derived | Dip F, LoMenzo E, Sarotto L, Phillips E, Todeschini H, Nahmod M, Alle L, Schneider S, Kaja L, Boni L, Ferraina P, Carus T, Kokudo N, Ishizawa T, Walsh M, Simpfendorfer C, Mayank R, White K, Rosenthal RJ. Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography. Ann Surg. 2019 Dec;270(6):992-999. doi: 10.1097/SLA.0000000000003178. |
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Redcap will be used Data to be shared - pre-operative data including age, sex, laboratory values and imaging, intra-operative data including visualization of the extra-hepatic biliary structure with white light and with infrared light by the operating surgeon and the observer, any bile leak; post-operative data documenting any complications such as reaction to ICG or bile duct injury.
Data will be available as each center finishes up the follow of each individual patient (usually 2 weeks post operatively). Each center will update the data on Redcap on a monthly basis.
Data will be initially obtained on a pre-decided forms (approved by the IRB committee) and transferred to Redcap for electronic record keeping and analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xenon Light | Laparoscopic cholecystectomy with Xenon Light Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light |
| FG001 | Near Infrared Light |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 16, 2017 |
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| OTHER |
| University of Rostock | OTHER |
| Hospital de Clinicas José de San Martín | OTHER |
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| Laparoscopic cholecystectomy (fluorescent cholangiography) | Procedure | Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively. |
|
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Hospital de clinicas jose de San Martin | Buenos Aires | Argentina |
| Askelopios Westklinikum Hamburg | Hamburg | Germany |
| Klinikum Sudstadt Rostock | Rostock | Germany |
| University of Insubria | Varese | Italy |
| University of Tokyo | Tokyo | Japan |
Laparoscopic cholecystectomy with Near infrared light
Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light
Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after a single injection of 5 cc of indocyanine green at least 30 minutes pre-operatively.
| COMPLETED |
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| NOT COMPLETED |
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All participants who completed the study procedures and had available documentation were included in the baseline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Xenon Light | Laparoscopic cholecystectomy with Xenon Light Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light |
| BG001 | Near Infrared Light | Laparoscopic cholecystectomy with Near infrared light Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light | Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification. | Posted | Count of Participants | Participants | Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure. |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xenon Light | Laparoscopic cholecystectomy with Xenon Light Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light | 1 | 318 | 2 | 318 | 4 | 318 |
| EG001 | Near Infrared Light | Laparoscopic cholecystectomy with Near infrared light Laparoscopic cholecystectomy with Xenon light: Standard laparoscopic cholecystectomy with white light Laparoscopic cholecystectomy (fluorescent cholangiography): Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively. | 0 | 321 | 0 | 321 | 1 | 321 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile Duct Injury | Hepatobiliary disorders | Non-systematic Assessment | Intraoperative Common Bile Duct Injury |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conversion to Open | Surgical and medical procedures | Non-systematic Assessment | Conversion from laparoscopy to laparotomy |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lo Menzo, M.D.,Emanuele | Cleveland Clinic Florida | 9546595000 | lomenze@ccf.org |
| May 5, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| United States |
|
| Japan |
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| Italy |
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| Germany |
|