To investigate the feasibility and utility of indocyanine green fluorescence imaging for intraoperative perfusion assessment in patients undergoing gastro-intestinal surgery, primarily measured by the number of intraoperative changes in operation…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility and utility of indocyanine green fluorescence imaging for
intraoperative perfusion assessment in patients undergoing gastro-intestinal
surgery, primarily measured by the number of intraoperative changes in the
level of anastomosis.
Secondary outcome
The effect of intraoperative indocyanine green fluorescence imaging in
gastro-intestinal surgery on:
- The occurrence of clinical/subclinical anastomotic leakage.
- Need for a colostomy.
- Adverse reactions on IV indocyanine green admission.
- Operation time.
- Need for additional surgical, radiological or endoscopic interventions.
- Other complications requiring treatment (i.e. urinary tract infection).
- Need for ICU admission and total length of ICU stay.
- Hospital stay.
Background summary
One of the most severe complications in gastro-intestinal surgery is the
occurrence of anastomotic leakage. An important factor in developing
anastomotic leakage is ischemia of the bowel ends. To better assess the
intra-operative blood perfusion of the bowel, intravenous indocyanine green
visualized with a near infrared camera can be used. Based on this imaging
technique, a better anastomosis site can be chosen and it might be possible to
reduce postoperative anastomotic leakages.
Study objective
To investigate the feasibility and utility of indocyanine green fluorescence
imaging for intraoperative perfusion assessment in patients undergoing
gastro-intestinal surgery, primarily measured by the number of intraoperative
changes in operation strategy (e.g. level of bowel anastomosis/avoidance stoma
formation).
Study design
A single-center prospective open label clinical trial performed at the
Catharina Hospital Eindhoven. It is expected that patients will be included
over a period of 1-2 years. On yearly bases, approximately 850 bariatric
procedures, 250 procedures for colorectal cancer, 50 procedures for esophageal
cancer and 40 procedures for gastric cancer are performed in our hospital.
Given the relatively non-invasive character of this study and the large group
of patients to be considered for inclusion, it can be expected that enough
patients can be included during the inclusion period. Since the Catharina
Hospital maintains a registry of all gastro-intestinal cancer and bariatric
patients undergoing surgery, this database can be used for a historic
matched-control group.
Intervention
Intra-operative intravenous injection of indocyanine green that can be
visualized with a near-infrared camera to assess the blood perfusion of the
organ. In case of a less perfused initial anastomosis site, a better-perfused
location can be chosen.
Study burden and risks
The only invasive intervention in the planned study is administration of
intravenous indocyanine green as contrast agent. This agent is registered for
the diagnostic use of assessing tissue perfusion, which is the same indication
it will be used for in the current study. The only risk for patients is an
allergic reaction to this agent, which has been described in <1/10000 patients.
Since indocyanine green will only be administered in a controlled setting
during surgery under general anesthesia and under supervision of an
anesthesiologist, adequate and immediate countermeasures in case of an allergic
reaction can be taken (such as the administration of antihistamines or
adrenaline). Besides this intervention, standard operative and postoperative
care will be given.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
* Patients that undergo elective gastrointestinal surgical resection with primary anastomosis or undergo a Roux-Y gastric bypass/gastric sleeve resection.
* Written informed consent
* Age >18 years
Exclusion criteria
* Peritoneal metastases found during surgery
* Pre-existent or creation of a diverting colostomy/ileostomy
* Pregnant or lactating women
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 | NL52669.100.15 |