Clinical trial NCT05517369: Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm
Official title: Impact of Using Hybrid-ESD+ and LiftUp® as Injectable on en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Adenoma
Keywords: Hybrid-ESD+
Endoscopic Resection
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Waid City Hospital, Zurich
name: University Hospital Ulm
name: Rems-Murr-Klinikum Winnenden
name: Insel Gruppe AG, University Hospital Bern
name: Klinikum Ludwigsburg
name: Mathilden Hospital Herford
name: St. Franziskus Hospital Münster
name: Agaplesion Kliniken Kassel
name: Ovesco Endoscopy AG
First posted: 2022-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+
timeFrame: after 14 days
Secondary outcomes:
measure: Complication rate (perforations, bleeding)
timeFrame: up to 4 weeks
measure: Recurrence rate
timeFrame: 6 months
measure: Procedural parameters - Intervention duration
timeFrame: 1 day
measure: Procedural parameters - Cleanliness of the colon
timeFrame: 1 day
measure: Localization of polyp
timeFrame: 1 day
measure: Polyp size
timeFrame: 1 day
measure: Polyp morphology
timeFrame: 1 day
measure: Polyp histology
timeFrame: 7 days
measure: Duration of hospital stay
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Herford
country: Germany
facility: Mathilden Hospital Herford
city: Kassel
country: Germany
facility: Agaplesion Diakonie Kliniken Kassel
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Münster
country: Germany
facility: St. Franziskus Hospital Münster
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Winnenden
country: Germany
facility: Rems-Murr-Klinikum Winnenden
city: Würzburg
country: Germany
facility: Universitätsklinik Würzburg
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zürich
country: Switzerland
facility: Stadtspital Waid
Study officials:
References: