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

Official Title:

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
N/A Interventional 18 Years and older Novadaq Technologies Inc. PP PLR 03
NCT02205307
Enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of General Surgery
Chief, Section of Colorectal Surgery 
Maurice Galante, MD Distinguished Professor in Surgical Oncology
Director, UCSF Center for Pelvic Physiology 

Jessica Rhee
Jessica.rhee@ucsfmedctr.org 


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.

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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