The primary objective is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. HGD or superficial oesophageal and/or gastric adenocarcinoma (T1)) during ESD.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to evaluate the feasibility of ICG-enhanced
near-infrared qFME to determine tumour demarcation and tumour depth in upper GI
tumours (e.g. HGD or superficial oesophageal and/or gastric adenocarcinoma
(T1)) compared to healthy tissue during ESD .
Secondary outcome
Secondary endpoints include: to histopathologically determine R0 resection rate
to, quantify and evaluate in vivo NIR fluorescent signals of indocyanine green
(ICG) by using multi-diameter single fiber reflectance / single fiber
fluorescence (MDSFR/SFF), to correlate these measurements to
signal-to-background ratios based on near-infrared qFME and to explore whether
the extrahepatic biliary anatomy (and the papilla of Vater) is endoscopically
visible by detecting fluorescent signals with ICG-enhanced near-infared qFME.
Background 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 be served as a red flag detection method and might be
useful imaging tool for tumour demarcation in the upper gastrointestinal tract.
Since these patients already receive ICG during fluorescence endoscopy, there
is a second exploratory research question. Another endoscopic procedure, called
ERCP, is used for treating bile duct and pancreatic diseases. This procedure
requires successful cannulation of the bile ducts, which fails in 5-20% of
cases. ICG is excreted via bile. Therefore, the researchers hypothesize that
near-infrared qFME with ICG may aid in better identifying the extrahepatic bile
ducts and the entry point from the intestine, the papilla of Vater, as bile
flows through this area. Therefore, a secondary, purely observational research
question is whether the papilla of Vater and the intraduodenal part of the bile
ducts will be endoscopically visible by detecting fluorescent signals after ICG
near-infrared qFME.
Study objective
The primary objective is to evaluate the feasibility of ICG-enhanced
near-infrared qFME to determine tumour demarcation and tumour depth in upper GI
tumours (e.g. HGD or superficial oesophageal and/or gastric adenocarcinoma
(T1)) during ESD.
Study design
The current study is a single-centre, non-randomized, non-blinded, feasibility
study.
Intervention
Intravenous administration of ICG in combination with near infrared quantified
fluorescence molecular endoscopy.
Study burden and risks
For the participating patients, there is no diagnostic or treatment benefit
related to the study. Participation may possibly lead to useful data for the
future research. The risk of participating in this study is the administration
of indocyanine green, an FDA approved dye that has a very low toxicity with a
complication rate of 0.05 - 0.07% . Clinical decisions will not be affected or
influenced by the imaging data.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Patients with confirmed high grade dysplasia or 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, shells and/or clams
* eGFR < 30 mL/min/1,73 m2
* pregnancy or provides breastfeeding
* Hyperthyroidism
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88635.042.24 |