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

Rectal Cancer Clinical Trial

— PILLAR III  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02205307
• Other study ID #: PP PLR 03
• Status: Terminated
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: June 2020
• Source: Novadaq Technologies ULC, now a part of Stryker
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 347
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Rectosigmoid Cancer

Intervention

Device:
• PINPOINT

• SPY Elite

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 to Week 8 (+/- 2 weeks)
Secondary	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	Day 0 (Day of Surgery)
Secondary	Incidence of Post-Operative Abscess Requiring Surgical Management	Rate of postoperative abscess requiring surgical management.	Day 0 to Week 8 (+/- 2 weeks)