Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery

NCT05489757 | Unknown DMC

• 1 other identifier: 154/INT/2021
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophagus; Fistula; Fistula;Rectal; Complication of Surgical Procedure; Complication,Postoperative

Keywords

ICG quantification; Esophagectomy; Colorectal resection; Perfusion assessment

Outcome Measures

Primary Outcomes (3)

• Maximum intensity of ICG fluorescence

  % (absolute value)

  One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.

• Time to first ICG fluorescence signal

  seconds

  One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.

• Time-to-peak

  seconds

  One timepoint: at day 0, after the externalization of colon/stomach, before packing the colorectal/esophagogastric anastomosis.

Secondary Outcomes (1)

• Correlation with postoperative outcomes

  From day 0 to day 30 after discharge

Interventions

SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software DEVICE

Perfusion assessment with SPY Q-ICG system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Absence of esophagogastric or colorectal reconstruction (e.g. Miles procedure)
• Limited sigmoid resection without ligation of the inferior mesenteric artery
• Known allergies, hypersensitivity or intolerance to indocyanine green (ICG) or iodine contrast agents,
• Patients with hyperthyroidism or benign thyroid tumor
• Acute or chronic kidney failure (stage ≥ 3)
• Pregnant or lactating women, or with a positive pregnancy test performed before surgery
• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Lorenzo Cinelli

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Esophageal Fistula; Rectal Fistula; Postoperative Complications

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Fistula; Intestinal Diseases; Rectal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Model Details: Prospective, Interventional, Monocentric Cohort Study on Medical Device (CE marked, according to indications for use) Prospective, Observational, Monocentric, Pharmacologic Cohort Study

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: August 5, 2022
• Study Start: February 16, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)