NCT04226781

Brief Summary

In this study, gastrointestinal anastomoses are examined with a hyperspectral camera and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

January 6, 2020

Last Update Submit

March 12, 2020

Conditions

AnastomosisPerfusion

Keywords

tissue perfusionhyperspectral imagingfluorescence imagingidocyaningreen (ICG)

Outcome Measures

Primary Outcomes (2)

  • Tissue oxygenation (StO2) in %

    Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue oxygen saturation value (StO2) in percent. These values are measured at a standardized distance from the anastomosis region.

    After the intraoperative Photo is taken, within 5 minutes

  • Anastomotic Perfusion in arbitrary units

    Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue perfusion in arbitrary units. (Method is described in attached literature) These values are measured at a standardized distance from the anastomosis region.

    After the intraoperative Photo is taken, within 5 minutes

Study Arms (2)

ICG

ACTIVE COMPARATOR

Fluorescence imaging for blood Perfusion of the gastrointestinal tissue

Diagnostic Test: Indocyaningreen-Fluorescence imaging

HSI

EXPERIMENTAL

Hyperspectralimaging for blood Perfusion of the gastrointestinal tissue

Diagnostic Test: Hyperspectral-Imaging

Interventions

Hyperspectral-ImagingDIAGNOSTIC_TEST

Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.

HSI
Indocyaningreen-Fluorescence imagingDIAGNOSTIC_TEST

Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis

ICG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all gastrointestinal anastomoses

You may not qualify if:

  • inability to consent
  • allergy against indocyaningreen dye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Leipzig - AöR

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (3)

  • Jansen-Winkeln B, Holfert N, Kohler H, Moulla Y, Takoh JP, Rabe SM, Mehdorn M, Barberio M, Chalopin C, Neumuth T, Gockel I. Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI). Int J Colorectal Dis. 2019 Apr;34(4):731-739. doi: 10.1007/s00384-019-03250-0. Epub 2019 Feb 2.

    PMID: 30712079BACKGROUND

  • Jansen-Winkeln B, Maktabi M, Takoh JP, Rabe SM, Barberio M, Kohler H, Neumuth T, Melzer A, Chalopin C, Gockel I. [Hyperspectral imaging of gastrointestinal anastomoses]. Chirurg. 2018 Sep;89(9):717-725. doi: 10.1007/s00104-018-0633-2. German.

    PMID: 29637244BACKGROUND

  • Jansen-Winkeln B, Germann I, Kohler H, Mehdorn M, Maktabi M, Sucher R, Barberio M, Chalopin C, Diana M, Moulla Y, Gockel I. Comparison of hyperspectral imaging and fluorescence angiography for the determination of the transection margin in colorectal resections-a comparative study. Int J Colorectal Dis. 2021 Feb;36(2):283-291. doi: 10.1007/s00384-020-03755-z. Epub 2020 Sep 23.

    PMID: 32968892DERIVED

Study Officials

  • Boris Jansen-Winkeln, MD, PD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Jansen-Winkeln, MD, PD

CONTACT

+49-314-97boris.jansen-winkeln@medizin.uni-leipzig.de

Ines Gockel, MD, Prof.

CONTACT

+49-314-97ines.gockel@medizin.uni-leipzig.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Deputy Head of Department, Priv.-Doz. Dr. med. habil.

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 13, 2020

Study Start

January 2, 2020

Primary Completion

December 31, 2020

Study Completion

June 20, 2021

Last Updated

March 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

no sharing

Locations

DE(1)