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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Francesc Xavier Molina, PhD contact

0034871205000 ext. 66135

xmolina@ssib.es

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.

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 groups in NCT04005898
Study groupRoleWhat they receive
Experimental: near-infrared cholangiographyExperimentalEach 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.

  1. 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.

  1. First posted2 Jul 2019
  2. Study startOct 2019 (estimated)
  3. Primary completionOct 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

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)
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

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.

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