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

Anastomotic Leak Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669485
• Other study ID #: UW 16027
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: January 29, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: The University of Hong Kong
• Contact: Dominic, Chi Chung Foo, MBBS
• Phone: 85222554389
• Email: ccfoo[@]hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

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

Device:
• Fluorescence imaging

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View 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. — View 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. — View 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. 2015 Oct 21. doi: 10.1002/rcs.1710. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging		intraoperative	No
Secondary	Anastomotic leak		up to 2 weeks after operation	No