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Perioperative Perfusion Measurement - a Feasibility and Usability Study

NCT03671642 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-12

No results posted yet for this study

Summary

This study will investigate a new method to assess tissue perfusion during surgery for esophageal cancer.

When a tumor in the distal esophagus is removed, the ends of the esophagus and the stomach must be reconnected by an anastomosis. An optimal perfusion is essential to ensure a good healing of the anastomosis. If anastomotic leakage occurs, it may prolong hospital stay, increase the risk of serious complications and death, delay start-up of chemotherapy and worsen the long-term survival prognosis.

During the operation the blood supply to the ends of the esophagus and stomach will be assessed in different ways; The traditional where the surgeon looks and feels on the tissue, and newer methods with an indocyanine green and cameras that illuminate the tissue with near-infrared light. The surgeon will assess whether these methods change the decision on where the ends should be sewn together.

Conditions

  • Esophageal Cancer

Interventions

DEVICE

Q-ICG

Quantitative perfusion assessment with indocyanine green on a touch screen tablet

PROCEDURE

White light perfusion assessment

Traditional visual perfusion assessment in white light

PROCEDURE

Fluorescence angiography

Perfusion assessment with fluorescence angiography - without quantification

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Michael P Achiam, MD,PhD,DMSci · Department of Surgical Gastroenterology, Rigshospitalet

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2019-03-11
Completion
2019-03-11

Countries

  • Denmark

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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 NCT03671642 on ClinicalTrials.gov