P0281 - Granulomatous Tissue Reaction Found at Orise Gel Submucosal Injection During One-year Follow-up Colonoscopy

Sheina Duncan, BSBE¹, Ahmad Farooq, MD^2
1University of Texas Medical Branch, Spring, TX; ²University of Texas Medical Branch at Galveston, Houston, TX

Introduction: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) procedures are minimally invasive approaches to remove gastrointestinal lesions with relatively low complication rates. Submucosal lifting agents are used to form barriers between gastrointestinal lesions and muscular layers to prevent tissue damage during EMR and ESD procedures. Orise^TM gel is a widely used lifting agent for resections. In 2022, a Class 2 Device Recall for Orise^TM was posted due to foreign body reactions, which presented as mass formations post-procedure often inciting inappropriate surgical interventions.

Case Description/Methods: Two patients have been identified as having received Orise^TM gel as a submucosal lifting agent at St. Joseph Medical Center in Houston, TX, between 1/20/2022 and 11/10/2022, performed by a single gastroenterologist. During the follow-up procedures, the gastroenterologist identified and biopsied the granulomatous tissue at the Orise^TM gel injection sites. The biopsy results for the patients were non-life threatening.

Discussion: The mechanism of action pertaining to the foreign body reaction producing granulomatous tissue at Orise^TM gel injection sites, specifically, is not entirely understood like other lifting agents. Foreign body granulation is a known histologic reaction in which multinucleated giant cells surround the foreign material. These reactions are benign but can cause complications, such as misinterpreted lesions leading to unnecessary surgical interventions. Further studies are needed to understand any potential long-term effects and complications of Orise^TM gel.


Disclosures:


Sheina Duncan, BSBE¹, Ahmad Farooq, MD². P0281 - Granulomatous Tissue Reaction Found at Orise Gel Submucosal Injection During One-year Follow-up Colonoscopy, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.