Cholecystitis/CholelithiasisNCT04005898
NIR Fluorescence Cholangiography With Low Dose of ICG
A study testing Near-infrared fluorescence cholangiography in people with Cholecystitis/Cholelithiasis, run by Hospital Son Espases.
Trial summary
The objective of this clinical trial is to visualize the bile ducts by injecting a contrast that is only visible with infrared light. For this, we administrate an intravenous low dose of ICG before a cholecystectomy. During the intervention the tissue will be exposed to infrared light to visualize the bile ducts. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholecystitis/Cholelithiasis
- What is being tested?
- Near-infrared fluorescence cholangiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective laparoscopic cholecystectomy.
- Normal liver and renal function.
- No hypersensitivity for iodine or indocianine green.
- Able to understand nature of the study procedures.
- Willing to participate and with written informed consent.
Who cannot join
- Age < 18 years.
- Liver or renal insufficiency.
- Known iodine or indocianine green hypersensitivity.
- Pregnancy or breastfeeding.
- Not able to understand nature of the study procedure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Near-infrared Incisionless Fluorescent Cholangiography With Low Dose of ICG
The objective of this clinical trial is to visualize the bile ducts by injecting a contrast that is only visible with infrared light. For this, we administrate an intravenous low dose of ICG before a cholecystectomy.
During the intervention the tissue will be exposed to infrared light to visualize the bile ducts. This technique aims to increase safety in surgery to avoid damaging bile or vascular structures during gallbladder interventions.
Read the detailed description
Laparoscopic cholecystectomy is one of the most commonly performed procedures in adult surgery. A rare but serious complication of laparoscopic cholecystectomy is bile duct injury, with a reported incidence of 0.3-1.5 %. Bile duct injury is often caused by misinterpretation of the anatomical structures rather than by insufficient technical skills. Generally, bile duct injury leads to bile leakage, causing abdominal sepsis. It can also lead to obstruction, with obstructive jaundice, eventually potentially leading to a need for liver transplantation in the worst case. Late recognition is common in bile duct injuries, resulting in significant morbidity and mortality, a lower quality of life and extra costs. A recent expert consensus report identified establishment of the critical view of safety as the single most important factor for overall safety during laparoscopic cholecystectomy. However, evidence suggests that surgeons may actually achieve this view far less often than they believe.
Numerous intraoperative visualization techniques and technologies have been developed to enhance the safety of laparoscopic cholecystectomy. There are mainly two intraoperative imaging techniques to consider: first, the historical X-ray-based intraoperative cholangiography, and secondly the emerging fluorescence-based intraoperative near-infrared cholangiography. Large retrospective and prospective studies have looked at the benefit of routine intraoperative radiographic cholangiography for detection of common bile duct stones and to identify or prevent bile duct injury. Whether this procedure should be performed routinely is still an active subject of debate as systematic reviews are inconclusive; however, several of the larger retrospective studies observed a decrease in frequency and severity of bile duct injury when intraoperative cholangiography is performed. Limiting factors for performing radiographic laparoscopic cholangiography include: it requires specific expertise in the technique and its interpretation; it involves the use of ionizing radiation; it is time-consuming; and it creates a risk for bile leakage and duct injury itself, since puncturing and cannulation of the cystic duct is required. These limitations justify the quest for alternative, less complicated techniques to visualize biliary anatomy during cholecystectomy. Fluorescence-based intraoperative near-infrared cholangiography during laparoscopic cholecystectomy has been introduced by Ishizawa et al. in recent years as a non-invasive, radiation-free, low-cost alternative for realtime visualization of the biliary anatomy. This technique requires near-infrared laparoscopic imaging systems, as well as the intravenous injection of a fluorophore, i.e., indocyanine green, which is eliminated through the biliary tree. Following exposure to the near-infrared fluorescenc light source, indocyanine green becomes fluorescent and highlights relevant biliary structures. Since the pioneer studies, a large number of trials have been conducted and several protocols are currently underway, in order to establish the clinical efficacy of near-infrared cholangiography. A recent systematic review of clinical studies on near-infrared cholangiography has reported high visualization rates of biliary structures, as a surrogate marker of clinical efficacy, before dissection of Calot's triangle. However, one of the most significant drawbacks of near-infrared cholangiography following systemic indocyanine green injection lies in the very high background signal due to the rapid accumulation of indocyanine green in the liver, which can impair the visualization of the biliary structures. The keys to avoiding this inconvenience are the dose of indocyanin green and the time of administration before the surgical procedure. So far, studies used a dose of indocyanin green above 2,5mg. To avoid this effect at these doses, the authors administer the contrast many minutes or even hours before starting the surgical procedure.
- Conditions
- Cholecystitis/Cholelithiasis
- Being tested
- Near-infrared fluorescence cholangiography
- Medical subject headings
- Cholecystitis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared fluorescence cholangiographyDevice
Real-Time Fluorescence Imaging (VISERA ELITE II Imaging System). These device is used to identify anatomy, using infrared light that causes the indocianine green to fluoresce.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: near-infrared cholangiography | Experimental | Each subject included in the study will be subjected to a fluorescence cholangiography. The control group will be the same patient. The study consists of knowing if fluorescence is able to visualize structures that are not seen with the naked eye. For this purpose the structures are visualized with normal light and then with infrared light of the same patient. During laparoscopic cholecystectomy it will change between normal and infrared light. Receives: Device: Near-infrared fluorescence cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of the cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction.
Percentage of patients for whom fluorescence allows visualize cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction with precision. cysticocholedochal junction.
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis/CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005898
- Sponsor's protocol ID
- XMOLICGEV
- Status last verified
- Jun 2019
- First submitted
- 30 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30614881
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Incisionless Fluorescent Cholangiography With Low Dose of ICG
- ClinicalTrials.gov ID
- NCT04005898
- Acronym / sponsor ID
- XMOLICGEV
- Conditions
- Cholecystitis/Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to visualize the bile ducts by injecting a contrast that is only visible with infrared light. For this, we administrate an intravenous low dose of ICG before a cholecystectomy.
During the intervention the tissue will be exposed to infrared light to visualize the bile ducts. This technique aims to increase safety in surgery to avoid damaging bile or vascular structures during gallbladder interventions.
Detailed description
Laparoscopic cholecystectomy is one of the most commonly performed procedures in adult surgery. A rare but serious complication of laparoscopic cholecystectomy is bile duct injury, with a reported incidence of 0.3-1.5 %. Bile duct injury is often caused by misinterpretation of the anatomical structures rather than by insufficient technical skills. Generally, bile duct injury leads to bile leakage, causing abdominal sepsis. It can also lead to obstruction, with obstructive jaundice, eventually potentially leading to a need for liver transplantation in the worst case. Late recognition is common in bile duct injuries, resulting in significant morbidity and mortality, a lower quality of life and extra costs. A recent expert consensus report identified establishment of the critical view of safety as the single most important factor for overall safety during laparoscopic cholecystectomy. However, evidence suggests that surgeons may actually achieve this view far less often than they believe.
Numerous intraoperative visualization techniques and technologies have been developed to enhance the safety of laparoscopic cholecystectomy. There are mainly two intraoperative imaging techniques to consider: first, the historical X-ray-based intraoperative cholangiography, and secondly the emerging fluorescence-based intraoperative near-infrared cholangiography. Large retrospective and prospective studies have looked at the benefit of routine intraoperative radiographic cholangiography for detection of common bile duct stones and to identify or prevent bile duct injury. Whether this procedure should be performed routinely is still an active subject of debate as systematic reviews are inconclusive; however, several of the larger retrospective studies observed a decrease in frequency and severity of bile duct injury when intraoperative cholangiography is performed. Limiting factors for performing radiographic laparoscopic cholangiography include: it requires specific expertise in the technique and its interpretation; it involves the use of ionizing radiation; it is time-consuming; and it creates a risk for bile leakage and duct injury itself, since puncturing and cannulation of the cystic duct is required. These limitations justify the quest for alternative, less complicated techniques to visualize biliary anatomy during cholecystectomy. Fluorescence-based intraoperative near-infrared cholangiography during laparoscopic cholecystectomy has been introduced by Ishizawa et al. in recent years as a non-invasive, radiation-free, low-cost alternative for realtime visualization of the biliary anatomy. This technique requires near-infrared laparoscopic imaging systems, as well as the intravenous injection of a fluorophore, i.e., indocyanine green, which is eliminated through the biliary tree. Following exposure to the near-infrared fluorescenc light source, indocyanine green becomes fluorescent and highlights relevant biliary structures. Since the pioneer studies, a large number of trials have been conducted and several protocols are currently underway, in order to establish the clinical efficacy of near-infrared cholangiography. A recent systematic review of clinical studies on near-infrared cholangiography has reported high visualization rates of biliary structures, as a surrogate marker of clinical efficacy, before dissection of Calot's triangle. However, one of the most significant drawbacks of near-infrared cholangiography following systemic indocyanine green injection lies in the very high background signal due to the rapid accumulation of indocyanine green in the liver, which can impair the visualization of the biliary structures. The keys to avoiding this inconvenience are the dose of indocyanin green and the time of administration before the surgical procedure. So far, studies used a dose of indocyanin green above 2,5mg. To avoid this effect at these doses, the authors administer the contrast many minutes or even hours before starting the surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: near-infrared cholangiography | Experimental | Device: Near-infrared fluorescence cholangiographyEach subject included in the study will be subjected to a fluorescence cholangiography. The control group will be the same patient. The study consists of knowing if fluorescence is able to visualize structures that are not seen with the naked eye. For this purpose the structures are visualized with normal light and then with infrared light of the same patient. During laparoscopic cholecystectomy it will change between normal and infrared light. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for elective laparoscopic cholecystectomy.
- Normal liver and renal function.
- No hypersensitivity for iodine or indocianine green.
- Able to understand nature of the study procedures.
- Willing to participate and with written informed consent.
Key exclusion criteria (5 listed)
- Age < 18 years.
- Liver or renal insufficiency.
- Known iodine or indocianine green hypersensitivity.
- Pregnancy or breastfeeding.
- Not able to understand nature of the study procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-infrared fluorescence cholangiographyReal-Time Fluorescence Imaging (VISERA ELITE II Imaging System). These device is used to identify anatomy, using infrared light that causes the indocianine green to fluoresce. | Device | Experimental: near-infrared cholangiography |
Primary outcome
Visualization of the cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction.
Time frame: Intra-operatively
Percentage of patients for whom fluorescence allows visualize cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction with precision. cysticocholedochal junction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 30614881Dip 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared fluorescence cholangiography in people with Cholecystitis/Cholelithiasis, run by Hospital Son Espases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesc Xavier Molina, PhD (0034871205000 ext. 66135, xmolina@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of the cystic duct, common hepatic duct, common bile duct and cysticocholedochal junction. (time frame: Intra-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.