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

Stopped early · Not applicable

Conditions studied: Rectal Cancer, Rectosigmoid Cancer

In brief

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.

Key facts

Study ID

NCT02205307

Run by

Novadaq Technologies ULC, now a part of Stryker

People needed

347

Starts

2015-01-01

Expected to finish

2017-05-01

Last updated by the study team

2020-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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