This study is designed to assess the feasibility of NIRF with ICG during open or minimal invasive esophagectomy in order to assess the gastric conduit perfusion.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Visualization of the perfusion of the gastric conduit and wash-in and
wash-out time of the ICG just before reconstruction of the anastomosis.
- Visualization of the perfusion of the anastomotic site after reconstruction
of the anastomosis, also measuring the wash-in and wash-out time of the ICG.
- Postoperative anastomotic leakage. Anastomotic leakage is defined as clinical
suspicion and confirmation by CT-scan of contrast, methylene blue, saliva or
other ingested material into the drain or signs of anastomotic leakage during
re-intervention or autopsy.
Secondary outcome
- Monitor the procedure time; the total time of the chirurgical procedure is
measured.
- Complications due to NIRF imaging with ICG
Background summary
Anastomotic leakage is a severe complication after esophagectomy and causes
major complications and mortality. Local ischemia to the most distal part of
the gastric conduit is thought to be the most important cause of anastomotic
leakage. Better assessment of the perfusion of the gastric conduit and to
identify the best level of the site of the anastomosis is needed. Near-infrared
fluorescence (NIRF) of the gastric conduit with Indocyanine green (ICG) is a
new technique to assess the gastric conduit perfusion. This technique is
already being used in some hospitals in the Netherlands and also wordwide.
Study objective
This study is designed to assess the feasibility of NIRF with ICG during open
or minimal invasive esophagectomy in order to assess the gastric conduit
perfusion.
Study design
Single center exploratory study
Study burden and risks
The included patient will undergo a esophagectomy with gastric conduit
reconstruction for esophageal cancer. In addition to this major procedure
patients will undergo NIRF imaging after intravenous ICG administration. No
additional treatments, testing, clinical visits or assessments are required
besides the standard patient care. Patients already have intravenous access
during the operation. ICG can cause (mild) side-effects in less than 0.0001% of
the patients.
Esophagectomy is a major procedure with a high morbidity and mortality.
Anastomotic leakage is a known severe complications. As this is an exploratory
study no clinical decision will be made on findings by fluorescence. It is
expected that the number of complications will not be different from regular
esophagectomy without ICG fluorescence. The outcome of this exploratory study
will potentially be of great importance to determine the added value of
intra-operative ICG fluorescence imaging to assess the gastric conduit
perfusion.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Patients scheduled for a minimal invasive (or open) esophagectomy for esophageal cancer with a gastric conduit reconstruction
- Aged 18 years or older
- Signed informed consent.
Exclusion criteria
- Known pregnancy or breastfeeding
- Known iodine, shellfish or ICG hypersensitivity
- Known hyper-thyroidism
- Known liver or renal insufficiency
- 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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64038.042.17 |