Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm

Study Overview
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Brief Summary
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This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.

Detailed Description
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There are several options for endoscopic polypectomy of polyps between 2-3 cm, all of which have their advantages and disadvantages and none of which has yet become the established standard procedure. Conventional EMR has the disadvantage of more frequent residuals and/or recurrences due to lack of en bloc resection, while ESD has the disadvantage of being more complex and complications more likely. A possible alternative is the use of hybrid ESD+ with LiftUp subcutaneous injection. The method with the LiftUp gel forming a stable gel cushion under the lesion, in combination with the circular circumcision of the mucosa at this site and the AWC for the current loop and the grasper, could achieve a better en bloc resection rate with a low complication rate than other procedures mentioned above. The higher effectiveness in terms of recurrences and complications could subsequently result in a reduction of endoscopic or surgical re-interventions. In this study, non-pedunculated colorectal polyps between 2 and 3cm in size are resected using ESD+ method and lift up as an injection solution. Methodological and clinical parameters are recorded. After 4 weeks, the patients are contacted by telephone to record possible late effects. If an endoscopic control is performed after 6 months (according to the guideline or according to the investigator), the findings are also recorded.

Official Title
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Impact of Using Hybrid-ESD+ and LiftUp® as Injectable on en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm.

Conditions
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Colorectal Adenoma

Intervention / Treatment
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* Procedure: Hybrid ESD+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm). Ablation medically indicated and possible (coagulation, etc. - as determined by the center) Exclusion Criteria: Age < 18 years Pedunculated lesion (Paris0-Ip) Size of the lesion <2cm or >3cm Pregnant and breastfeeding women Patient not capable of informed consent / consent not possible Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma Non-lifting sign / known recurrence after previous therapy Impassable stenosis in the colon / rectum Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection As per contraindications from the AWC & LiftUp Instructions for Use: The AWC is not to be used if flexible-endoscopic procedures are contraindicated. The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables. LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid-ESD+<br>All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method. | Procedure: Hybrid ESD+<br>* Injection of the Lift Up solution, followed by circumcision of the lesion using a snare tip or ESD knife. Using an additional working channel (AWC), the lesion is resected using a grasper and snare.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+ | In how many cases a complete R0 resection (basal and lateral margin) is found on pathologic examination | after 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate (perforations, bleeding) | Perforation: dehiscence of the muscularis propria diagnosed during or after resection. Hemorrhage: Clinically significant post-endoscopic bleeding (CSPEB). Bleeding from the ablation site with hematochezia after completion of index colonoscopy Intraprocedural bleeding (IPB). Percent, defined as bleeding lasting > 60 seconds during intervention necessitating therapy | up to 4 weeks | 
| Recurrence rate | Rate of adenoma residue and/or adenoma recurrence in percent after 6 months. This is determined by the colonoscopic and histologic findings from 2 biopsies from the scar or resection specimen. | 6 months | 
| Procedural parameters - Intervention duration | Intervention duration (time range from injection to complete resection) | 1 day | 
| Procedural parameters - Cleanliness of the colon | Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9) | 1 day | 
| Localization of polyp | Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum) | 1 day | 
| Polyp size | Polyp diameter in mm | 1 day | 
| Polyp morphology | according to paris classification | 1 day | 
| Polyp histology | histological examination (tubular, tubulovillous, villous) | 7 days | 
| Duration of hospital stay | Time frame from first day to discharge | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hybrid-ESD+, Endoscopic Resection