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Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

NCT04709445 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-14

No results posted yet for this study

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.

Conditions

  • 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

Interventions

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709445 on ClinicalTrials.gov