The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery

Inflammatory Bowel Disease Clinical Trial

Official title:

The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02598414
• Other study ID #: ICG-COLORECTAL
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 2, 2015
• Last updated: November 22, 2015
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Acibadem University
• Contact: Volkan Ozben, MD
• Phone: +905346484678
• Email: volkanozben[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time.

Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is able to give informed consent for participation in the study

• Subject is willing and able to comply with the study procedures

• Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision

• Subject is scheduled for robotic colon or rectal resection

• A negative pregnancy test for women of childbearing potential prior to surgery

Exclusion Criteria:

• Subjects present with bowel obstruction or perforation

• Subject undergo emergency surgery

• Subject with ASA IV, V

• History of allergy or hypersensitivity against indocyanine green

• Pregnant or breast-feeding women

• Subject has uremia (serum creatinine >2.5 mg/dl)

• Subject is undergoing palliative surgery or who is terminally ill

• Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery

• Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Colon Neoplasms
• Colonic Neoplasms
• Diverticular Disease
• Diverticulum
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Neoplasms
• Rectal Neoplasms

Intervention

Procedure:
• Near-infrared ICG fluorescence imaging
Patient will have their bowel anastomosis assessed intraoperatively by near-infrared technology after indocyanine green has been injected intravenously at a concentration of 2.5 mg/ml. This procedure will be repeated twice during surgery, the first time before and the second time after the anastomosis has been done. The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
• Traditional bowel anastomosis
Traditional bowel anastomosis will be performed without ICG fluorescence imaging.

Device:
• FireFly™
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Acibadem University	Acibadem Atakent University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 — View Citation

Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leak rate	Anastomotic leak rate within 30 post operative days	Postoperative 30 days	No
Secondary	Complication rate	Complication rate within postoperative 30 days	Postoperative 30 days	No
Secondary	Mortality	Mortality within 30 post operative days	Postoperative 30 days	No