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

Colorectal Adenoma Clinical Trial

— HADRIAN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05517369
• Other study ID #: Brand_HADRIAN_10_08_2022
• Secondary ID: WHO Universal Tr
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	Mathilden Hospital Herford	Herford
Germany	Agaplesion Diakonie Kliniken Kassel	Kassel
Germany	Klinikum Ludwigsburg	Ludwigsburg
Germany	St. Franziskus Hospital Münster	Münster
Germany	Universitätsklinikum Ulm	Ulm
Germany	Rems-Murr-Klinikum Winnenden	Winnenden
Germany	Universitätsklinik Würzburg	Würzburg
Switzerland	Inselspital Bern	Bern
Switzerland	Stadtspital Waid	Zürich

Sponsors (10)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Agaplesion Kliniken Kassel, Insel Gruppe AG, University Hospital Bern, Klinikum Ludwigsburg, Mathilden Hospital Herford, Ovesco Endoscopy AG, Rems-Murr-Klinikum Winnenden, St. Franziskus Hospital Münster, University Hospital Ulm, Waid City Hospital, Zurich

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Procedural parameters - Intervention duration	Intervention duration (time range from injection to complete resection)	1 day
Secondary	Procedural parameters - Cleanliness of the colon	Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9)	1 day
Secondary	Localization of polyp	Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum)	1 day
Secondary	Polyp size	Polyp diameter in mm	1 day
Secondary	Polyp morphology	according to paris classification	1 day
Secondary	Polyp histology	histological examination (tubular, tubulovillous, villous)	7 days
Secondary	Duration of hospital stay	Time frame from first day to discharge	up to 4 weeks