This study is designed to explore the feasibility and added value of NIRF in minimally invasive esophagectomy and secondly to assess gastric conduit perfusion with intravenous injection of ICG.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To explore the feasibility and added value of NIRF to assess gastric conduit
perfusion in minimally invasive esophagectomy.
Secondary outcome
- Indentify the increase in procedure time
Background summary
Anastomotic leakage after esophagectomy is an early post-operative complication
and a major cause of morbidity and mortality. Impaired arterial bloodflow of
the gastric conduit is thought to be the most important cause of anastomotic
leakage. Better assessment of gastric conduit perfusion and identification of
the ideal level of anastomosis is needed. A promising technique to assess the
gastric conduit perfusion intra-operatively is near-infrared fluorescence
(NIRF) imaging after injection with indocyanine green (ICG).
Study objective
This study is designed to explore the feasibility and added value of NIRF in
minimally invasive esophagectomy and secondly to assess gastric conduit
perfusion with intravenous injection of ICG.
Study design
Single center exploratory study
Study burden and risks
Included patients are already considered for esophagectomy and will undergo an
intravenous injection of ICG. This is the only additional (minimally) invasive
action for the patient. No additional treatments, testing, clinic visits or
assessments are required besides the standard patient care. ICG can cause
(mild) side-effects in less than 0.0001% of the patients. Esophagectomy is
associated with high morbidity and mortality, in which anastomotic leakage
plays an important role. However, since no clinical decisions will be made on
findings by ICG fluorescence, the number of serious adverse events due to the
surgical procedure is not expected to be different from regular esophagectomy
without ICG fluorescence imaging. The outcome of this exploratory study will
potentially be of great importance to determine the added value of
intra-operative ICG fluorescence imaging for assessment of gastric conduit
perfusion.
Geert grooteplein 10
Nijmegen 6525GA
NL
Geert grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* All patients eligible for minimally invasive esophagectomy for easophageal cancer, with gastric conduit reconstruction and intrathoracic gastro-esophageal anastomosis
* Aged 18 years or older
* Providing informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in the study:
* Known Liver or renal insufficiency
* Known pregnancy or breastfeeding
* Known iodine, shellfish or ICG hypersensitivity
* Unable to provide informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58179.091.16 |
| OMON | NL-OMON23045 |