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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-31

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.

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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.

Conditions

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Colorectal Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hybrid-ESD+

All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method.

Group Type EXPERIMENTAL

Hybrid ESD+

Intervention Type PROCEDURE

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.

Interventions

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Hybrid ESD+

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No