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

Not Applicable

• Conditions: Anastomotic Leak
• Interventions: Drug: indocyanine green; Device: Fluorescence imaging

• Registration Number: NCT02669485
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-29
• Last Update Submitted: 2016-01-29
• Study First Posted: 2016-02-01
• Last Update Posted: 2016-02-01
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging	intraoperative

Secondary Outcome Measures

Name	Time	Method
Anastomotic leak	up to 2 weeks after operation

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong