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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

18 years of age and older
Undergoing an LAR for the treatment of rectal neoplasms
Subjects with rectal neoplasm(s) may be treated with or without neoadjuvant therapy. Neoadjuvant therapy must have been completed ≥6 weeks prior to surgery
Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge, with or without reservoir/pouch

Exclusion Criteria:

Undergoing a robotic or robotic assisted (da Vinci® Surgical System) LAR
Undergoing ileoanal reconstruction, proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy)
Diagnosis of Stage IV rectal cancer or locally advanced rectal cancer undergoing extended en bloc operations
Intra-operative incidental finding of Stage IV cancer with isolated metastasis of a cumulative size of ≤ 2 cm does not exclude the subject
Diagnosis of inflammatory bowel disease
Hepatic dysfunction defined as MELD Score >10
Renal dysfunction with creatinine >2.0
Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Pregnant or lactating female

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Ron Landmann, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Ron Landmann, M.D.

Closed for enrollment

More information

Publications

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