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

NCT ID: NCT02669485

Last Updated: 2016-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Anastomotic Leak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ICG

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

Group Type EXPERIMENTAL

indocyanine green

Intervention Type DRUG

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

Fluorescence imaging

Intervention Type DEVICE

Interventions

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indocyanine green

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

Intervention Type DRUG

Fluorescence imaging

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Dominic C.C. Foo

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominic, Chi Chung Foo, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Dominic, Chi Chung Foo, MBBS

Role: CONTACT

85222554389

Facility Contacts

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Dominic, Chi Chung Foo, MBBSA

Role: primary

85222554389

Nga Fun Shumj, PhD

Role: backup

85222551250

References

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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.

Reference Type BACKGROUND
PMID: 26486376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24385249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25451666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23289664 (View on PubMed)

Other Identifiers

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UW 16027

Identifier Type: -

Identifier Source: org_study_id

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