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

Primary Purpose

Rectal Cancer, Rectosigmoid Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PINPOINT
SPY Elite
Sponsored by
Novadaq Technologies ULC, now a part of Stryker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal cancer, Rectal neoplasm, Colorectal surgery, Anastomosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • John Muir Medical Center, Concord Campus
  • Kaiser Permanente
  • University of California, Irvine
  • University of California, San Francisco
  • Mayo Clinic - Jacksonville
  • University of South Florida
  • Cleveland Clinic Florida
  • Rush University Medical Center
  • Indiana University
  • Ochsner Clinic
  • Johns Hopkins
  • Massachusetts General Hospital
  • Barnes Jewish Medical Center
  • Sunrise Hospital and Medical Center
  • Mount Sinai Beth Israel
  • Mount Sinai Medical Center
  • Weill Cornell Medical College
  • The Christ Hospital
  • Cleveland Clinic
  • University Hospitals Cleveland Medical Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • Baylor University Medical Center
  • Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PINPOINT or SPY Elite

STANDARD

Arm Description

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

A low anterior resection will be performed according to the surgeon's standard practice

Outcomes

Primary Outcome Measures

Anastomotic Leak Rate
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

Rate of SPY Visualization and Tissue Perfusion
The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure
Incidence of Post-Operative Abscess Requiring Surgical Management
Rate of postoperative abscess requiring surgical management.

Full Information

First Posted
July 29, 2014
Last Updated
June 22, 2020
Sponsor
Novadaq Technologies ULC, now a part of Stryker
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1. Study Identification

Unique Protocol Identification Number
NCT02205307
Brief Title
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Acronym
PILLAR III
Official Title
A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novadaq Technologies ULC, now a part of Stryker

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Rectosigmoid Cancer
Keywords
Rectal cancer, Rectal neoplasm, Colorectal surgery, Anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PINPOINT or SPY Elite
Arm Type
Experimental
Arm Description
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
Arm Title
STANDARD
Arm Type
No Intervention
Arm Description
A low anterior resection will be performed according to the surgeon's standard practice
Intervention Type
Device
Intervention Name(s)
PINPOINT
Intervention Type
Device
Intervention Name(s)
SPY Elite
Primary Outcome Measure Information:
Title
Anastomotic Leak Rate
Description
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.
Time Frame
Day 0 to Week 8 (+/- 2 weeks)
Secondary Outcome Measure Information:
Title
Rate of SPY Visualization and Tissue Perfusion
Description
The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure
Time Frame
Day 0 (Day of Surgery)
Title
Incidence of Post-Operative Abscess Requiring Surgical Management
Description
Rate of postoperative abscess requiring surgical management.
Time Frame
Day 0 to Week 8 (+/- 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Stamos, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Wexner, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Muir Medical Center, Concord Campus
City
Concord
State/Province
California
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California, Irvine
City
Orange
State/Province
California
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Barnes Jewish Medical Center
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33872284
Citation
Jafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007.
Results Reference
derived

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

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