NCT02669485

Brief Summary

The aim of this study was to evaluate the impact of fluorescence imaging on the location of colorectal transection lines based on evaluation of perfusion with indocyanine green, how it's going to affect surgical planning and its possible benefits in reducing anastomotic leakage.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

January 21, 2016

Last Update Submit

January 29, 2016

Conditions

Anastomotic Leak

Keywords

ICGcolectomyanastomotic leakanastomotic leakage ratesurgical decision

Outcome Measures

Primary Outcomes (1)

  • Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging

    intraoperative

Secondary Outcomes (1)

  • Anastomotic leak

    up to 2 weeks after operation

Study Arms (1)

ICG

EXPERIMENTAL

Administering indocyanine green during surgery and the use of ICG fluorescence imaging to assess bowel perfusion during surgery

Drug: indocyanine greenDevice: Fluorescence imaging

Interventions

indocyanine greenDRUG

Injection of indocyanine green and using fluorescence imaging to assess perfusion of bowel before bowel transection and anastomosis

ICG
Fluorescence imagingDEVICE
ICG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All left-sided colorectal resection involving division of inferior mesenteric artery

You may not qualify if:

  • Patients with a history of adverse reaction or known allergy to ICG, iodine, or iodine dyes. Pregnant and/or lactating patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

  • Kim JC, Lee JL, Yoon YS, Alotaibi AM, Kim J. Utility of indocyanine-green fluorescent imaging during robot-assisted sphincter-saving surgery on rectal cancer patients. Int J Med Robot. 2016 Dec;12(4):710-717. doi: 10.1002/rcs.1710. Epub 2015 Oct 21.

    PMID: 26486376BACKGROUND

  • Hellan M, Spinoglio G, Pigazzi A, Lagares-Garcia JA. The influence of fluorescence imaging on the location of bowel transection during robotic left-sided colorectal surgery. Surg Endosc. 2014 May;28(5):1695-702. doi: 10.1007/s00464-013-3377-6. Epub 2014 Jan 3.

    PMID: 24385249BACKGROUND

  • Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ. Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg. 2015 Jan;220(1):82-92.e1. doi: 10.1016/j.jamcollsurg.2014.09.015. Epub 2014 Sep 28.

    PMID: 25451666BACKGROUND

  • Gurtner GC, Jones GE, Neligan PC, Newman MI, Phillips BT, Sacks JM, Zenn MR. Intraoperative laser angiography using the SPY system: review of the literature and recommendations for use. Ann Surg Innov Res. 2013 Jan 7;7(1):1. doi: 10.1186/1750-1164-7-1.

    PMID: 23289664BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Indocyanine GreenOptical Imaging

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Dominic, Chi Chung Foo, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic, Chi Chung Foo, MBBS

CONTACT

85222554389ccfoo@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 1, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

February 1, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)