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The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

Primary Purpose

Anastomotic Leak

Status

Unknown status

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

indocyanine green

Fluorescence imaging

About this trial

This is an interventional diagnostic trial for Anastomotic Leak focused on measuring ICG, colectomy, anastomotic leak, anastomotic leakage rate, surgical decision

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anastomotic leak

Full Information

NCT ID

NCT02669485

First Posted

January 21, 2016

Last Updated

January 29, 2016

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT02669485

Brief Title

The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

Official Title

A Prospective Study to Investigate the Impact of Using Indocyanine Green-enhanced Fluorescence Imaging on the Location of Bowel Transection in Patients Undergoing Left-sided Colorectal Resection

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

During surgery, the line of intended bowel transection would be determined by the surgeon. Then the anesthesiologist will administer a bolus of 5mg ICG intravenously (2.5mg/ml, 2ml), followed by 10ml normal saline flush. The perfusion of colon will be assessed via fluorescence angiography. The actual bowel transection, after ICG fluorescence study, would be compared with the intended bowel transection site. The difference in terms of distance and either more proximal or distal is recorded. Then bowel anastomosis is completed in the usual manner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anastomotic Leak

Keywords

ICG, colectomy, anastomotic leak, anastomotic leakage rate, surgical decision

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICG

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

indocyanine green

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Fluorescence imaging

Primary Outcome Measure Information:

Title

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

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

Anastomotic leak

Time Frame

up to 2 weeks after operation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All left-sided colorectal resection involving division of inferior mesenteric artery Exclusion Criteria: Patients with a history of adverse reaction or known allergy to ICG, iodine, or iodine dyes. Pregnant and/or lactating patients.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominic, Chi Chung Foo, MBBS

Phone

85222554389

ccfoo@hku.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominic, Chi Chung Foo, MBBS

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominic, Chi Chung Foo, MBBSA

Phone

85222554389

ccfoo@hku.hk

First Name & Middle Initial & Last Name & Degree

Nga Fun Shumj, PhD

Phone

85222551250

frankie_shum2002@yahoo.com.hk

First Name & Middle Initial & Last Name & Degree

Dominic, Chi Chung Foo, MBBS

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26486376

Citation

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.

Results Reference

background

PubMed Identifier

24385249

Citation

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.

Results Reference

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PubMed Identifier

25451666

Citation

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.

Results Reference

background

PubMed Identifier

23289664

Citation

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.

Results Reference

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The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

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