ClinicalTrials.gg
Status unknownNCT04005898Updated Jul 2, 2019

NIR Fluorescence Cholangiography With Low Dose of ICG

An interventional study of Near-infrared fluorescence cholangiography in Cholecystitis/Cholelithiasis, sponsored by Hospital Son Espases. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by Hospital Son Espases · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Cholecystitis/Cholelithiasis
03

In context

Cholecystitis

272 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's planned enrollment of 80 is close to the median of 87 across 172 interventional studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Hospital Son Espases is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Scheduled for elective laparoscopic cholecystectomy.
  2. Normal liver and renal function.
  3. No hypersensitivity for iodine or indocianine green.
  4. Able to understand nature of the study procedures.
  5. Willing to participate and with written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years.
  2. Liver or renal insufficiency.
  3. Known iodine or indocianine green hypersensitivity.
  4. Pregnancy or breastfeeding.
  5. Not able to understand nature of the study procedure.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental: near-infrared cholangiography

    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.

    Device: Near-infrared fluorescence cholangiography

Interventions

  • DeviceNear-infrared fluorescence cholangiography

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: Intra-operatively

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2019; primary completion for Oct 2021, 24 months later.

Of 79 non-industry interventional studies with no phase under Cholecystitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 24 months is above that.

Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 9 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2019
First posted
Jul 2, 2019
StartEst.
Oct 2019
Primary completionEst.
Oct 2021
CompletionEst.
Jun 2022
Last update
Jul 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04005898
Lead sponsor
Hospital Son Espases
Responsible party
Sponsor
First posted
Jul 2, 2019
Start date
Oct 2019 (estimated)
Primary completion
Oct 2021 (estimated)
Completion
Jun 2022 (estimated)
Last update
Jul 2, 2019

Study contacts

Francesc Xavier Molina, PhD
Contact
xmolina@ssib.es
0034871205000 ext. 66135

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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