Clinical trial NCT04886609: ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.
Official title: ORISE Study: Evaluation of Novel Injecting Solution (ORISE) During Endoscopic Resection of Colorectal Polyps.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Polyp
Keywords: ORISE gel
EMR
ESD
Colorectal polyps
submucosal injection
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2021-05-14
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasability
timeFrame: 1 year
measure: Effectiveness
timeFrame: 1 year
measure: Safety - Presence of Muscle fibers in the resected specimen
timeFrame: 1 year
measure: Safety - Complications
timeFrame: 1 year
Secondary outcomes:
measure: Total injected volume per lesion size
timeFrame: 1 year
measure: Sydney Resection Quotient
timeFrame: 1 year
measure: Feasability
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Humaitas Research Hospital
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospital NHS Trust
state: Hampshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: Kings College Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Portsmouth Hospitals University NHS Trust
name: Pradeep Bhandari, Prof
role: PRINCIPAL_INVESTIGATOR
References: