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

Not Applicable

Withdrawn

• Conditions: Colorectal Adenoma
• Interventions: Procedure: Hybrid ESD+

• Registration Number: NCT05517369
• Lead Sponsor: Wuerzburg University Hospital

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.

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-26
• Study Start: 2023-03-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-04
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	6 months	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.
Procedural parameters - Intervention duration	1 day	Intervention duration (time range from injection to complete resection)
Procedural parameters - Cleanliness of the colon	1 day	Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9)
Polyp morphology	1 day	according to paris classification
Complication rate (perforations, bleeding)	up to 4 weeks	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
Localization of polyp	1 day	Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum)
Polyp size	1 day	Polyp diameter in mm
Polyp histology	7 days	histological examination (tubular, tubulovillous, villous)
Duration of hospital stay	up to 4 weeks	Time frame from first day to discharge

Trial Locations

Locations (9)

Agaplesion Diakonie Kliniken Kassel; 🇩🇪 Kassel, Germany

Mathilden Hospital Herford; 🇩🇪 Herford, Germany

St. Franziskus Hospital Münster; 🇩🇪 Münster, Germany

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Inselspital Bern; 🇨🇭 Bern, Switzerland

Rems-Murr-Klinikum Winnenden; 🇩🇪 Winnenden, Germany

Universitätsklinik Würzburg; 🇩🇪 Würzburg, Germany

Stadtspital Waid; 🇨🇭 Zürich, Switzerland