Esophageal Carcinoma, Gastric Carcinoma
Conditions
Keywords
Indocyanine Green (ICG), Fluorescence Molecular Endoscopy
Brief summary
Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and/or gastric adenocarcinoma (T1)) during ESD.
Interventions
Systemic administration of indocyanine green during the endoscopic procedure.
DIAGNOSTIC_TESTFluorescence guided identification using indocyanine green
Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG; * Age of 18 years or older; * Able to provide written informed consent.
Exclusion criteria
(contraindications for indocyanine green): * Known allergy to indocyanine green; * Known allergies to iodine, shellfish and/or clams; * eGFR \< 30 mL/min/1.73 m2; * Pregnancy or breastfeeding; * Hyperthyroidism. * Severe liver disease (ascites and cirrhosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD | One week after the qFME procedure | Feasibility will be assessed by analyzing the fluorescent imaging data obtained during and after the procedure. Visible fluorescence will be determined by calculating the target-to-background ratio (TBR), where the target is defined as the mean pixel intensity of the resection bed in areas displaying fluorescence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME | One week after the qFME procedure | Visibility is determined visual evaluation during the endoscopic procedure and calculating the TBR in the same manner as explained above. |
Countries
Netherlands
Contacts
Primary ContactWouter B. Nagengast, MD, PharmD, PhD
Outcome results
None listed