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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

Studienlocations
(1 von 1)

Charité Campus Benjamin Franklin
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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