NCT03671642

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 8, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

August 8, 2018

Last Update Submit

March 11, 2019

Conditions

Esophageal Cancer

Keywords

perfusionindocyanine green angiographyfeasibility study

Outcome Measures

Primary Outcomes (1)

  • Completion rates

    Feasibility of perfusion assessment with traditional visual, visual FA, and Q-ICG

    during surgery

Secondary Outcomes (2)

  • Differences in resection points

    up to 6 months

  • System Usability Scale

    up to one week

Study Arms (1)

Perfusion assessment

EXPERIMENTAL

Q-ICG: quantitative perfusion assessment with FA White light perfusion assessment FA: fluorescence angiography without quantification

Device: Q-ICGProcedure: White light perfusion assessmentProcedure: Fluorescence angiography

Interventions

Q-ICGDEVICE

Quantitative perfusion assessment with indocyanine green on a touch screen tablet

Perfusion assessment
White light perfusion assessmentPROCEDURE

Traditional visual perfusion assessment in white light

Perfusion assessment
Fluorescence angiographyPROCEDURE

Perfusion assessment with fluorescence angiography - without quantification

Perfusion assessment

Eligibility Criteria

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

You may qualify if:

  • Patients (above 18 years) scheduled for planned open or robot-assisted resection of the gastroesophageal junction (GI junction) for GI junctional cancer.

You may not qualify if:

  • Allergy towards; iodine, indocyanine green or shellfish
  • Liver insufficiency
  • Thyrotoxicosis
  • Pregnancy or lactation
  • Legally incompetent for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgical Gastroenterology - Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

Related Publications (1)

  • Nerup N, Andersen HS, Ambrus R, Strandby RB, Svendsen MBS, Madsen MH, Svendsen LB, Achiam MP. Quantification of fluorescence angiography in a porcine model. Langenbecks Arch Surg. 2017 Jun;402(4):655-662. doi: 10.1007/s00423-016-1531-z. Epub 2016 Nov 15.

    PMID: 27848028BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Michael P Achiam, MD,PhD,DMSci

    Department of Surgical Gastroenterology, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-fellow, senior resident

Study Record Dates

First Submitted

August 8, 2018

First Posted

September 14, 2018

Study Start

August 8, 2018

Primary Completion

March 11, 2019

Study Completion

March 11, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)