Impact of Hybrid-ESD+ and LiftUp® on the en Bloc/R0 Rate in Colorectal Adenomas Between 2 and 3 cm (HADRIAN)
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- STATUS
- Recruiting
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- End date
- Oct 23, 2024
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- participants needed
- 60
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- sponsor
- Wuerzburg University Hospital
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.
Details
| Condition | Colorectal Adenoma |
|---|---|
| Treatment | Hybrid ESD+ |
| Clinical Study Identifier | NCT05517369 |
| Sponsor | Wuerzburg University Hospital |
| Last Modified on | 7 October 2022 |
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