A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Novadaq Technologies ULC, now a part of Stryker24 sites in 1 country347 target enrollmentJanuary 2015

ConditionsRectal Cancer Rectosigmoid Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Cancer
Sponsor: Novadaq Technologies ULC, now a part of Stryker
Enrollment: 347
Locations: 24
Primary Endpoint: Anastomotic Leak Rate
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

May 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novadaq Technologies ULC, now a part of Stryker

Responsible Party

Sponsor

Eligibility Criteria

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
•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 \>

Outcomes

Primary Outcomes

Anastomotic Leak Rate

Time Frame: 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 Outcomes

Incidence of Post-Operative Abscess Requiring Surgical Management(Day 0 to Week 8 (+/- 2 weeks))
Rate of SPY Visualization and Tissue Perfusion(Day 0 (Day of Surgery))