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Spots Global Cancer Trial Database for Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm

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Trial Identification

Brief Title: 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 ID: NCT05517369

Interventions

Hybrid ESD+

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, , Germany

Inselspital Bern, Bern, , Switzerland

Stadtspital Waid, Zürich, , Switzerland

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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