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

June 22, 2020 updated by: Novadaq Technologies ULC, now a part of Stryker

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Concord, California, United States
        • John Muir Medical Center, Concord Campus
      • Los Angeles, California, United States
        • Kaiser Permanente
      • Orange, California, United States
        • University of California, Irvine
      • San Francisco, California, United States
        • University of California, San Francisco
    • Florida
      • Jacksonville, Florida, United States
        • Mayo Clinic - Jacksonville
      • Tampa, Florida, United States
        • University of South Florida
      • Weston, Florida, United States
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States
        • Barnes Jewish Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Hospital and Medical Center
    • New York
      • New York, New York, United States
        • Weill Cornell Medical College
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
      • New York, New York, United States
        • Mount Sinai Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • The Christ Hospital
      • Cleveland, Ohio, United States
        • Cleveland Clinic
      • Cleveland, Ohio, United States
        • University Hospitals Cleveland Medical Center
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States
        • Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PINPOINT or 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
Device: PINPOINT
Device: SPY Elite
NO_INTERVENTION: STANDARD
A low anterior resection will be performed according to the surgeon's standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 to Week 8 (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of SPY Visualization and Tissue Perfusion
Time Frame: 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
Day 0 (Day of Surgery)
Incidence of Post-Operative Abscess Requiring Surgical Management
Time Frame: Day 0 to Week 8 (+/- 2 weeks)
Rate of postoperative abscess requiring surgical management.
Day 0 to Week 8 (+/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novadaq Technologies ULC, now a part of Stryker

Investigators

  • Principal Investigator: Steven Wexner, MD, Cleveland Clinic Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (ESTIMATE)

July 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP PLR 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Cancer

Clinical Trials on PINPOINT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe