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

Colorectal Polyp Clinical Trial

— ORISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886609
• Other study ID #: 275810
• Status: Recruiting
• Start date: March 25, 2021
• Est. completion date: April 24, 2023

Study information

• Verified date: September 2022
• Source: Portsmouth Hospitals NHS Trust
• Contact: Pradeep Bhandari
• Phone: 02392 286000
• Email: pradeep.bhandari[@]porthosp.nhs.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

Device:
• ORISE gel
To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps

Locations

Country	Name	City	State
Italy	Humaitas Research Hospital	Milan
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Portsmouth Hospital NHS Trust	Portsmouth	Hampshire

Sponsors (5)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	Humanitas Hospital, Italy, King's College Hospital NHS Trust, Leeds General Infirmary, Oxford University Hospitals NHS Trust

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

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