Identification of the thoracic duct using a vital dye in patients undergoing minimally invasive esophagectomy

Phase 1

• Conditions: Chylothorax is a serioso post-operative complication, which occurs in 2-12% of patients undergoing esophagectomy. Thoracic duct lesion leads to a reduction of body fluids and albumin resulting in hypovolemia, also delays oral food intake, increase hospital stay and negatively affects overall survival. It is also associated with pneuomonia resulting in difficulty breathing, which also determines an increased risk of sepsis.; MedDRA version: 20.0Level: PTClassification code 10051228Term: ChylothoraxSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-004374-25-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Patients aged 18 or over
2. American Society of Anesthesiologists’ (ASA) class I, II or III;
3. Elective surgery patients;
4. Patients’ written acceptance to be included in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

Exclusion Criteria

1. Class IV-V of the American Society of Anesthesiologists (ASA)
2. Patients with hyperthyroidism and / or autoimmune adenomas of the thyroid
3. Allergy to contrast medium, hypersensitivity to iodine, indocyanine green or sodium iodide.
4. Patients who cannot undergo transthoracic esophagectomy
5. Pregnancy or breastfeeding or positive pregnancy test (to be performed in potentially fertile women)
6. Severe kidney failure (estimated GFR <30 mL / min / 1.73 m2 at the time of screening)
7. Participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives of the study drug
8. Any clinical condition that in the investigator's judgment would make the patient unsuitable for the study
9. Patients who refuse to give their written consent to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to demonstrate the feasibility to use near infrared (NIR) fluorescence guided thoracoscopy to identify the thoracic duct anatomy and check for intraoperative lesions during minimally invasive esophagectomy.;Secondary Objective: The incidence of adverse reactions, pain, iatrogenic injury and / or complications at the site of ICG injection.;Primary end point(s): This study intends to demonstrate the feasibility of using indocyanine green in thoracoscopy guided by near-infrared fluorescence (NIR) to identify the TD anatomy and verify the presence of intraoperative lesions during minimally invasive esophagectomy.;Timepoint(s) of evaluation of this end point: The timepoints of evaluation of this end point is represented by the surgical time for thoracoscopic esophagectomy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evaluate the incidence of adverse reactions, pain, iatrogenic injury and / or complications at the site of ICG injection.;Timepoint(s) of evaluation of this end point: From the end of the VERDEDT procedure to the discharge of the patient undergoing oesophagectomy.