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

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

Study Overview

• Status: Terminated
• Conditions: Colorectal Polyp
• Intervention / Treatment: Device: ORISE gel

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20089
    • Humaitas Research Hospital
• United Kingdom
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All patients undergoing EMR or ESD at each recruiting centre who meet below eligibility criteria will be invited to participate.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: King's College Hospital NHS Trust; Oxford University Hospitals NHS Trust; Humanitas Hospital, Italy; Leeds General Infirmary
• Investigators: Principal Investigator: Pradeep Bhandari, Prof, Portsmouth Hospitals University NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ESD; EMR; Colorectal polyps; ORISE gel; submucosal injection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: 275810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Non identifiable Data regards primary and secondary outcome measures to be shared with other investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No