In this trial we will study the utility of PerfusiX-Imaging for perfusion assessment of the gastric conduit in comparison with the standard of care.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All patients will undergo the standard-of-care program which includes perfusion
assessment by the surgical eye and ICG-fluorescence imaging. In addition to
this standard-of-care, 2D-perfusion maps will be generated from images taken
with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) in
combination with a standard surgical laparoscope. Not related to the patient,
the PerfusiX-Imaging images will be shown to the surgeon postoperatively and
peroperative questionnaires will be filled regarding the standard-of-care
perfusion assessment.
Study parameters/endpoints
Due to the explorative character of this study, there is no formal hierarchy in
the respective endpoints of this study. In this, all endpoints will add to the
overall assessment of the feasibility of the PerfusiX-imaging derived visual
feedback. We will look at the percentage of operating surgeons that indicated
no change in location of the anastomosis or operating plan based on the
additional PerfusiX-Imaging. The percentage of the non-involved surgeons that
indicated no change in location of the anastomosis or operating plan based on
the additional PerfusiX-Imaging. The comparison will be made between these two
groups by looking at the proportion of the indication of a change in location
by operating and non-involved surgeons between patients with and without AL and
Perfusix-Imaging. And the homogeneity of the change in location between
non-involved surgeons for individual patients will be analyzed in order to get
a sense for the subjectivity of the interpretation of the images.
We will also compare the additional PerfusiX-Imaging derived visual
feedback to the standard of care by looking at the homogeneity in location of
the watershed area between PerfusiX-Imaging, ICG-fluorescence and based on
visual assessment by the surgical eye. The difference in the location of
watershed area between PerfusiX-Imaging and ICG-fluorescence or based on visual
assessment.
In order to get a sense of the scale of the indicated change in
location of the anastomosis we will look at the estimated change in location of
the anastomosis of the gastric conduit/ the esophageal stump in centimeters by
the operating surgeon. The estimated change in location of the anastomosis of
the gastric conduit/ the esophageal stump in centimeters by non-involved
surgeons. Lastly, we will compare the change in the location of the anastomosis
by non-involved surgeons in comparison to the operating surgeon;
Secondary outcome
N/A
Background summary
Globally, esophageal cancer is the seventh most common cancer type, with over
half a million cases reported in 2020. The survival of gastroesophageal cancer
is poor and the prognosis is primarily determined by the possibilities for
curative treatment. After resection of part of the esophagus and cardia, the
reconstruction of the esophagus is performed with a gastric conduit where an
anastomosis is made with the proximal esophageal stump. Globally, a Minimally
invasive Esophagectomy (MIE) has a high morbidity rate and a mortality rate
ranging up to 5% as a result of the procedure. One of the most feared
complications is an anastomotic leakage (AL) with a rate of around 12.5% and a
mortality rate of around 15%. AL is associated with prolonged hospital stay and
increased re-operation rates. It is generally accepted that impaired blood flow
of the gastric conduit is the most important cause of AL. The surgical
procedure of an esophagectomy and reconstruction inherently compromises the
blood supply of the gastric conduit. However other than the surgical eye, there
is no gold standard in assessing this. Surgeons generally look for traditional
indicators of tissue viability such as pulsating vessels, bleeding of the
resected edges, tissue color and intestinal motility. However, an objective
indication of the tissue perfusion is still lacking, implying the clinical need
for one.
Study objective
In this trial we will study the utility of PerfusiX-Imaging for perfusion
assessment of the gastric conduit in comparison with the standard of care.
Study design
The current study is a prospective, observational single-center study in the
Medical Center. All 30 patients will undergo the standard-of-care program which
includes perfusion assessment by the surgical eye and ICG-fluorescence imaging.
In addition to this standard-of-care, 2D-perfusion maps will be generated from
images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The
Netherlands) in combination with a standard surgical laparoscope. Not related
to the patient, the PerfusiX-Imaging images will be shown to the surgeon
postoperatively and peroperative questionnaires will be filled regarding the
standard-of-care perfusion assessment.
Study burden and risks
The total surgery is expected to take 5 minutes longer. There are no known
risks. Patients did not directly benefit from this study. The surgery proceeds
as normal, with the addition of the additional perfusion measurements. During
the operation, no decisions are made on the laser speckle images.
Henri dunantweg 2
Leeuwarden 8934AD
NL
Henri dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
Scheduled to undergo esophageal resection
Exclusion criteria
Other interventions than esophageal resections
Design
Recruitment
Medical products/devices used
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 | NL81217.099.22 |