JOURNAL ONKOLOGIE – STUDIE
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
Rekrutierend
NCT-Nummer:
NCT04709445
Studienbeginn:
März 2020
Letztes Update:
14.01.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Diverticulitis, Neoplasms, Pancreatic Neoplasms, Adenomatous Polyposis Coli, Gastrointestinal Neoplasms, Crohn Disease, Intestinal Obstruction
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Charite University, Berlin, Germany
Collaborator:
-
Kontakt
Kontakt:
Phone: +49 30 450 622 798
E-Mail: benjamin.weixler@charite.de» Kontaktdaten anzeigen
Kontakt:
Phone: +49 30 450 622 789
E-Mail: leonard.lobbes@charite.de» Kontaktdaten anzeigen
Studienlocations
(1 von 1)
12203 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Benjamin Weixler, MD PD
Phone: +49 30 450 622798
E-Mail: benjamin.weixler@charite.de
Leonard Lobbes, MD
Phone: +49 30 450 622789
E-Mail: leonard.lobbes@charite.de» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description:Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property
of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and
bowel perfusion.
The investigators hypothesise that ICG-NIRF is a suitable, reliable and precise method of
visualisation of the blood supply and bowel perfusion in the area of gastrointestinal and
hepatobiliary anastomosis formation.
In this prospective, non-randomized cohort study, the respective upper GI, lower GI or
hepatobiliary procedure with anastomosis is performed according to standard of care and
indication for the corresponding disease including non-malignant, malignant and inflammatory
conditions. The following procedures are included in the study, in open or laparoscopic
surgery, according to the surgeon's choice:
Upper GI surgery:
- Esophageal resection
- Subtotal or total gastrectomy with or without jejunal pouch reconstruction
- Y-Roux-reconstruction
- Right or left colonic interposition (iso- or antiperistaltic)
Lower GI surgery:
- Jejunal or ileal segmental resection
- Ileal / Ileocoecal resection
- Colectomy with restorative ileal pouch formation and ileal-pouch-anal anastomosis
- Left or right-sided hemicolectomy
- Sigmoid resection
- Rectal resections (lower anterior resection (LAR), proctectomy with colo-anal
anastomosis, abdominoperineal resection)
- Stoma closure
Hepatobiliary surgery:
- Pancreaticoduodenectomy
Written informed consent for participation and ICG-administration is obtained one day before
surgery.
Intraoperatively, Indocyanine Green (ICG, VerDye, Diagnostic Green GmbH, Aschheim Germany, 25
mg vials) is dissolved in 5 mL sterile water to yield a 5 mg/mL concentration. It will then
be administered intravenously at three consecutive time points as a bolus of 2 ml per time
point at the most. The overall dose of ICG will amount to no more than 30mg of ICG per
patient.
Real-time intraoperative visualization is performed with the SpectrumTM Fluorescence Imaging
Platform (Quest Innovations, Middenmeer, The Netherlands) directly after each ICG injection
assessing bowel perfusion at two different time points per anastomosis respectively: before
and after anastomosis formation.
Postoperative NIRF-perfusion rate assessment Using the Quest Research SoftwareTM, the
recordings before and after anastomosis formation will be analysed for their perfusion rate.
This analysis will provide objective, quantitative data on the perfusion for a certain time
frame which is determined by the length of the video recording. This data will be collected
for statistical analysis and correlation with anastomotic leak as well as postoperative
outcome.
Clinical data and follow-up Clinical data will be collected from all patients regarding
anastomotic leak, bowel ischemia and necrosis as well as 30 day postoperative morbidity,
mortality and length and cost of hospital stay.
Further data analysis will be performed using Microsoft Excel® and IBM SPSS®.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Age ≥ 18
- capability of signing informed consent
- diagnosis of malignancies of the upper gastrointestinal tract (GI), or malignancies of
the lower GI, or malignancies of the hepatobiliary system, refractory ulcerative
colitis, or Crohn's disease, or acute, inflammatory, degenerative functional or
anatomical disorders
- Surgery possible and medically indicated to the diagnosis (esophageal resection, or
subtotal or total gastrectomy, or Y-Roux reconstruction, or right or left colonic
interposition, or small bowel segment resection, or ileocecal resection, or colectomy,
or proctectomy with restorative ileoanal pouch (one or two-stage), or left or right
hemicolectomy, or sigmoid resection, or rectal resection (deep anterior resection
(TAR)), or proctectomy with colo-anal anastomosis, or abdominoperineal resection, or
stoma closure, or pancreaticoduodenectomy
Exclusion Criteria:
- liver disfunction (MELD score > 10)
- ICG (indocyanine green) specific exclusion criteria as per literature (intolerance to
indocyanine green or sodium iodide, iodine allergy, hyperthyroidism, autonomous
thyroid adenoma, focal or diffuse autonomies of the thyroid, previously badly
tolerated injection of ICG)
- pregnancy or breastfeeding
Studien-Rationale
Primary outcome:1. anastomotic leak (Time Frame - 30 days):
number of patients suffering from an anastomotic leak within 30 days of operation
Secondary outcome:
1. Operative and post-operative complications (Time Frame - 30 days):
Clavien-Dindo for complication-level classification
2. Length of hospital stay (Time Frame - 100 days):
length in days
Geprüfte Regime
- ICG-NIRF Imaging plus ingress and egress analysis:
intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) before and after anastomosis formation, postoperative analysis of ingress and egress for specific regions of interest
Quelle: ClinicalTrials.gov
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