In this trial we will study the utility of PerfusiX-Imaging for the identification of intersegmental planes during thoracoscopic segmentectomy.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 Als laatste
for detecting interlobar and intersegmental planes in lung tissue. We will
compare the difference in location of both the interlobar and intersegmental
planes as derived from visual feedback from the PerfusiX-imaging system, with
images derived from ICG imaging and the surgical eye. During the procedure, the
time needed to generate and acquire the visual feedback from the
PerfusiX-imaging system will be determined. We will also determine the
interpretability of the visual feedback from the PerfusiX-imaging system by
users (surgeons). In addition, we will determine Laser Speckle Perfusion Unit
(LSPU) cut-off values of PerfusiX-imaging in lung tissue with the highest
sensitivity and specificity for the indication of level of tissue perfusion.
Secondary outcome
Not applicable
Background summary
Lung cancer remains to be the leading cause of cancer-related deaths
worldwide1. The current standard-of-care for small lung cancer is a total
lobectomy. Albeit effective with respect to the radical excision of the tumour,
the substantial loss in lung tissue may be clinically relevant, especially in
combination with frequently co-existing lung diseases. Thoracoscopic
segmentectomy is a combination of adequate oncological resection with
lung-tissue-sparing properties and is being increasingly used because of its
several advantages compared with lobar resections. By defining the segment that
has to be excised pre-operatively, the key to successful pulmonary
segmentectomy is to subsequently intraoperatively recognize the intersegmental
planes correctly. The conventional and most common method uses a ventilation
method (inflation/deflation technique). With the increasing availability of
laparoscopic imaging systems, indocyanine green (ICG) fluorescence imaging is a
more advanced method to determine intersegmental planes. The major limitation
is the use of an exogenous contrast agent. After injection, the ICG only has
very limited *imaging time window* (minutes) in which the images can be used to
determine the intersegmental planes. Furthermore, the use of dye limits
repeatability of measurements due to rest ICG, the extra operating room time
required for the injection, wash-in and wash-out of the dye as well as change
of camera settings. These limitations leave room for new technologies and
improvements. We hypothesized that a laparoscopic laser speckle imaging device
could overcome the limitations of ICG-fluorescence imaging and could thus be a
very useful addition in intersegmental plane detection. PerfusiX-Imaging (LIMIS
Development BV, Leeuwarden, The Netherlands) is such a laparoscopic laser
speckle contrast imager that has been developed in the Medical Centre
Leeuwarden since 2014. LSCI has never been used to identify intersegmental
planes, however, based on the similarities between LSCI and ICG-fluorescence,
this novel imaging approach is thought to be effective and potentially could be
used as a standard-of-care.
Study objective
In this trial we will study the utility of PerfusiX-Imaging for the
identification of intersegmental planes during thoracoscopic segmentectomy.
Study design
The current study is a prospective, observational single-centre study in the
Medical Center Leeuwarden.
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 8923 AD
NL
Henri Dunantweg 2
Leeuwarden 8923 AD
NL
Listed location countries
Age
Inclusion criteria
Scheduled to undergo upper left or right lobectomy
Exclusion criteria
Medical or psychiatric conditions that compromise the patient*s ability to give
informed consent
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 |
---|---|
ClinicalTrials.gov | NCT05545085 |
CCMO | NL82338.099.22 |