ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.

Study Overview
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Brief Summary
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Is ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps.

Detailed Description
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Endoscopic resection of large colonic polyps is preferred over Surgical resections due to lower morbidity and preservation of the colon and its functions. The use of submucosal injection is essential for a successful resection (EMR/ ESD). Injection of fluid into the submucosa cushions and isolates the tissue just before capture of the target lesion with a snare, thereby reducing thermal injury and the risk of perforation during EMR. ESD requires a long period of submucosal dissection and that involves multiple injections to maintain the submucosal cushion; without which the risk of perforation increases. A mixture of normal saline solution + epinephrine and blue dye like indigo carmine is the commonly used injecting solution. However, Saline dissipates very quickly leading to frequent and multiple injections. This leads to longer procedure time. Studies have demonstrated long-lasting effects of colloids when injected in the submucosal space. ORISE gel is a newly licensed injecting solution which contains a poloxamer agent leading to longer lasting submucosal cushion effect. Multicentre prospective observational cohort study Primary Objective : Primary Objective To evaluate the technical feasibility, effectiveness & safety of the ORISE gel as an injecting solution on its own during endoscopic resection of colorectal polyps (ability to start and finish the resection with ORISE). Secondary Objective : To identify Polyp Resection Time (PRT) and the amount of ORISE gel used during resection of large colorectal polyps.

Official Title
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ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.

Conditions
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Colorectal Polyp

Intervention / Treatment
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* Device: ORISE gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old at the date of consent Subjects referred for EMR for the excision of: Treatment naïve, laterally spreading sessile, flat polyps or adenomas of the colon equal to or greater than 20 mm in largest dimension, assessed by the investigator to be suitable for EMR or ESD. Exclusion Criteria: Lesions less than 20 mm in largest dimension Subjects with ulcerated depressed lesions (Paris type III-excavated) or biopsy proven invasive carcinoma Scarred polyps Endoscopic appearance of deep invasive malignancy Previous partial resection or attempted resection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ORISE gel|To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasability | Ease of use, rated on a 5-point visual analog scale for: very easy, easy, neutral, difficult and very difficult. | 1 year | 
| Effectiveness | Number of patients where alternatives to ORISE gel had to be used to complete the procedure | 1 year | 
| Safety - Presence of Muscle fibers in the resected specimen | Presence of Muscle fibers in the resected specimen | 1 year | 
| Safety - Complications | Complications: Perforationpost polypectomy syndrome, Intra procedural bleeding, post procedural | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total injected volume per lesion size | Total injected volume per lesion size: calculated by dividing the injected volume needed to complete the EMR procedure (in mL) by the lesion size (in mm2). | 1 year | 
| Sydney Resection Quotient | Sydney Resection Quotient: calculated by dividing the lesion size (in mm2) by the number of resections required to remove the lesion | 1 year | 
| Feasability | Polyp Resection Time | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMR, ORISE gel, ESD, Colorectal polyps, submucosal injection