Építés alatt – nem éles oldal
Belépés

NCT05489757Befejeződött

Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery

SPY Portable Handheld Imaging (SPY-PHI) System With SPY-QP Software for Quantitative Fluorescence Angiography With IndoCyanine Green for Perfusion Assessment During Surgery

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 27.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening consequences resulting in worsened short- and long-term outcomes. Consistently, a recent meta-analysis showed a correlation between AL and shorter disease-free survival in colorectal surgery. Despite its multifactorial origin, AL is highly related to inadequate visceral perfusion. Traditionally, perfusion assessment and subsequent anastomotic viability have been evaluated by surgeons using intraoperative indicators, such as color, pulsation of vessels, presence of peristalsis and bleeding from the resection lines. However, these clinical parameters are not able to reliably assess the real visceral perfusion and their evaluation is limited in minimally invasive surgery. Hence, the growing interest for innovative techniques able to properly assess tissue perfusion. Among these, the fluorescence angiography (FA) with indocyanine green (ICG) has become increasingly popular during the last decade, although its approval for biomedical purposes by the Food and Drug Administration (FDA) dates back to 1956. ICG is an amphiphilic, non-toxic, tricarbocyanine iodide dye that can be safely injected intravenously and is exclusively eliminated by the liver, without any absorption. Thanks to its fluorescent properties, it allows the real-time visualization of tissue vascularization. FA with ICG has shown promising results for the evaluation of perfusion in numerous surgical procedures, thus leading to modifications of the surgical strategy and consequently to a decrease in the rates of AL. On the other hand, ICG interpretation is subjective, based on the evaluation of fluorescence performed by the operating surgeon. These results lack into a high inter-observer variability and affect the possibility to obtain objective, reproducible and reliable tissue perfusion assessments. Quantitative fluorescence angiography with ICG (Q-ICG) could overcome these limitations. In Q-ICG the fluorescence signal is elaborated by a new computer quantification algorithm and translated into a fluorescence-time curve (FTC), from which several Q-ICG parameters and values can be extracted. Given the power of ICG in reflecting the perfusion of examined tissues, a new quantification algorithm has the potential to turn the subjective parameters derived from surgeon's perspective into objective numeric values. The primary aim of this study is to evaluate which Q-ICG values provided by a new quantification algorithm correspond to subjective perfusion parameters usually evaluated by the surgeon in patients undergoing left colon, rectal or esophagogastric resections. The secondary aim is to evaluate possible correlations between Q-ICG values provided by the quantification algorithm and perioperative outcomes.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
196 (tényleges)
Első benyújtás
2022. jún. 24.
Kezdés
2022. febr. 16.
Elsődleges befejezés
2026. máj. 19.
Fő szponzor
IRCCS San Raffaele
NCT-szám
NCT05489757

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 196
  • 2022. febr. 16. és az elsődleges befejezés (2026. máj. 19.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Limited sigmoid resection without ligation of the inferior mesenteric artery
  • Pregnant or lactating women, or with a positive pregnancy test performed before surgery

Más betegség

  • Known allergies, hypersensitivity or intolerance to indocyanine green (ICG) or iodine contrast agents,
  • Acute or chronic kidney failure (stage ≥ 3)
  • Any clinical condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Egyéb

  • Absence of esophagogastric or colorectal reconstruction (e.g. Miles procedure)
  • Patients with hyperthyroidism or benign thyroid tumor

Kiket keres a vizsgálat

  • The participant is willing and able to give informed consent for participation in the trial
  • Male and Female, Age > 18 years
  • Patients undergoing left colon, rectal or esophagogastric resections
  • Patients with malignant or benign disease
  • Minimally invasive or open approach surgery

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Riccardo RosatiMilanOlaszországIsmeretlen állapot

Te vagy a koordinátor? Erősítsd meg az adatokat

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.