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Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

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ClinicalTrials.gov Identifier: NCT04709445
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
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 two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

Condition or disease Intervention/treatment Phase
Bowel Obstruction Bowel Ischemia Diverticulitis Abnormality of the Gastrointestinal Tract Symptomatic Disorders of the Gastrointestinal Tract Stoma Ileostomy Cancer of the Gastrointestinal Tract Crohn Disease Ulcerative Colitis Familial Adenomatous Polyposis Pancreatic Neoplasms Hepatobiliary Neoplasm Diagnostic Test: ICG-NIRF Imaging plus ingress and egress analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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: Objective Perfusion Rate Assessment of Gastrointestinal Anastomoses by Inflow and Outflow Analysis of Near-infrared Fluorescence Agents
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: ICG-NIRF Imaging and objective perfusion rate
Intraoperatively, ICG-NIRF imaging is used to visualize the blood supply and the rate of tissue perfusion in the area of the anastomotic site. Postoperatively, an additional ingress and egress analysis at specific regions of interest is performed.
Diagnostic Test: 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




Primary Outcome Measures :
  1. anastomotic leak [ Time Frame: 30 days ]
    number of patients suffering from an 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 hospital stay [ Time Frame: 100 days ]
    length in days



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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04709445


Contacts
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Contact: Benjamin Weixler, PD MD +49 30 450 622 798 benjamin.weixler@charite.de
Contact: Leonard Lobbes, MD +49 30 450 622 789 leonard.lobbes@charite.de

Locations
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Germany
Charité Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Benjamin Weixler, MD PD    +49 30 450 622798    benjamin.weixler@charite.de   
Contact: Leonard Lobbes, MD    +49 30 450 622789    leonard.lobbes@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Publications:

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Responsible Party: Benjamin Weixler, Attending Physician, Assistant Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04709445    
Other Study ID Numbers: EA1/087/20
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
objective perfusion rate
near infrared fluorescence
anastomotic leak
image guided surgery
anastomosis
perfusion assessment
Additional relevant MeSH terms:
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Diverticulitis
Neoplasms
Pancreatic Neoplasms
Adenomatous Polyposis Coli
Gastrointestinal Neoplasms
Crohn Disease
Intestinal Obstruction
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn