A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Not Applicable

Terminated

Conditions: Rectal Cancer
Rectosigmoid Cancer

Interventions: Device: PINPOINT
Device: SPY Elite

Registration Number: NCT02205307

Lead Sponsor: Novadaq Technologies ULC, now a part of Stryker

Brief Summary: This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 347

Inclusion Criteria

Be 18 years of age or older.
Be undergoing open, or minimally invasive LAR for the treatment of a rectal or rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been completed ≥6 weeks prior to LAR surgery (Day 0).
Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge.
Have a colorectal or coloanal reconstruction with or without reservoir/pouch.
Subjects who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at Day 0.
Have signed an approved informed consent form for the study.
Be willing to comply with the protocol.

Exclusion Criteria

Undergoing stapled anastomosis with the use of an experimental or non-FDA approved stapler.
Undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy).
Has received and completed a course of pelvic radiotherapy ≥ 6 months prior to LAR surgery (Day 0).
Has previously undergone a left sided colon resection.
Has previously undergone a rectal resection.
Has recurrent rectal or rectosigmoid cancer.
Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended en bloc operations.
Has a diagnosis of Stage IV rectal or rectosigmoid cancer with any multifocal metastases or single site metastasis with tumor size of > 2 cm (Intraoperative incidental finding or preoperative suspicion of Stage IV cancer with isolated (single site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in size, does not exclude the subject).
Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or rectosigmoid cancer neoplasms and IBD are excluded.
Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score >12.
Renal dysfunction defined as creatinine ≥ 2.0 mg/dL.
Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PINPOINT or SPY Elite	SPY Elite	A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion
PINPOINT or SPY Elite	PINPOINT	A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion

Primary Outcome Measures

Name	Time	Method
Anastomotic Leak Rate	Day 0 to Week 8 (+/- 2 weeks)	Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

Secondary Outcome Measures

Name	Time	Method
Incidence of Post-Operative Abscess Requiring Surgical Management	Day 0 to Week 8 (+/- 2 weeks)	Rate of postoperative abscess requiring surgical management.
Rate of SPY Visualization and Tissue Perfusion	Day 0 (Day of Surgery)	The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure

Trial Locations

Locations (24): John Muir Medical Center, Concord Campus
🇺🇸
Concord, California, United States
Weill Cornell Medical College
🇺🇸
New York, New York, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of California, Irvine
🇺🇸
Orange, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Kaiser Permanente
🇺🇸
Los Angeles, California, United States
Ochsner Clinic
🇺🇸
New Orleans, Louisiana, United States
Barnes Jewish Medical Center
🇺🇸
Saint Louis, Missouri, United States
Mount Sinai Beth Israel
🇺🇸
New York, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Mayo Clinic - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Sunrise Hospital and Medical Center
🇺🇸
Las Vegas, Nevada, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Cleveland Clinic Florida
🇺🇸
Weston, Florida, United States
Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Baylor University Medical Center
🇺🇸
Dallas, Texas, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States