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

Wuerzburg University Hospital

Status: Withdrawn

Conditions: Colorectal Adenoma

Treatments: Procedure: Hybrid ESD+

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05517369

Brand_HADRIAN_10_08_2022

WHO Universal Trail Number (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Hybrid-ESD+

Experimental group

Description:

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

Treatment:

Procedure: Hybrid ESD+