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Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04695964
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 15, 2021
Information provided by (Responsible Party):
Benjamin Weixler, Charite University, Berlin, Germany

Brief Summary:
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Colorectal Cancer Crohn Disease Familial Adenomatous Polyposis Ulcerative Colitis in Remission Ulcerative Colitis Chronic Crohn Colitis Ileal Pouch Diagnostic Test: ICG-NIRF Imaging plus ingress and egress analysis Not Applicable

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 ileal pouch formation and the ileal pouch-anal anastomosis.

In this prospective, non-randomized cohort study, restorative proctocolectomy with ileal pouch reconstruction and ileal pouch-anal anastomosis is performed according to standard of care for medically-refractory ulcerative colitis (UC), UC-associated neoplasia, medically-refractory Crohn´s colitis, colorectal carcinoma or familial adenomatous polyposis (FAP) in open or laparoscopic surgery, according to the surgeon's choice.

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 three different time points respectively: before and after J-Pouch construction by stapler anastomosis and after ileoanal 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®.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a non-randomised prospective cohort study design.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Objective Perfusion Rate Assessment by Near-infrared Fluorescence During Restorative Ileal Pouch Formation and Ileal-pouch-anal Anastomosis
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
ICG-NIRF Imaging and objective perfusion rate
ICG-NIRF imaging is used to visualise the blood supply and the bowel perfusion rate in the area of the pouch anastomoses. An additional ingress and egress analysis at specific regions of interest is performed. This is to get an objective method of visualisation of the blood inflow and outflow over time and thus bowel perfusion at the anastomotic site.
Diagnostic Test: ICG-NIRF Imaging plus ingress and egress analysis
intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3) Additional ingress and egress analysis (inflow and outflow analysis) of specificities regions of interest at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)

Primary Outcome Measures :
  1. anastomotic leak [ Time Frame: 30 days ]
    occurence anastomotic leak within 30 days of operation

Secondary Outcome Measures :
  1. Operative and post-operative complications [ Time Frame: 30 days ]
    Clavien-Dindo for complication-level classification

  2. Length of post-operative hospital stay [ Time Frame: 100 days ]
    length in days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age ≥ 18
  • capability of signing the informed consent
  • diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease, familial adenomatous polyposis
  • restorative proctocolectomy (RPC) with reconstruction through ileal pouch formation and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated
  • ASA (American Society of Anesthesiologists) Physical Status Classification System score ≤ 3

Exclusion Criteria:

  • coexistent malignant tumor of a different ethology
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04695964

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Contact: Benjamin Weixler, PD MD +49 30 450 622 798
Contact: Leonard Lobbes, MD +49 30 450 622 789

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Charité Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Benjamin Weixler, MD PD    +49 30 450 622798   
Contact: Leonard Lobbes, MD    +49 30 450 622789   
Sponsors and Collaborators
Charite University, Berlin, Germany

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Responsible Party: Benjamin Weixler, Attending Physician, Assistant Professor, Charite University, Berlin, Germany Identifier: NCT04695964    
Other Study ID Numbers: EA4/116/19/2
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: this will be determinable at a later point when more data is available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Weixler, Charite University, Berlin, Germany:
indocyanine green
restorative proctocolectomy
ileal pouch-anal anastomosis
objective perfusion rate
near-infrared fluorescence
ulcerative colitis
anastomotic leak
image guided surgery
Additional relevant MeSH terms:
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Adenomatous Polyposis Coli
Crohn Disease
Colitis, Ulcerative
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn