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| ID | Type | Description | Link |
|---|---|---|---|
| WHO Universal Trail Number | Other Identifier | U1111-1281-5357 |
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No participants fitting into the study
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| Name | Class |
|---|---|
| Waid City Hospital, Zurich | OTHER |
| University Hospital Ulm | OTHER |
| Rems-Murr-Klinikum Winnenden | UNKNOWN |
| Insel Gruppe AG, University Hospital Bern |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid-ESD+ | Experimental | All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid ESD+ | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate (perforations, bleeding) | Perforation: dehiscence of the muscularis propria diagnosed during or after resection. Hemorrhage:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mathilden Hospital Herford | Herford | 32052 | Germany | |||
| Agaplesion Diakonie Kliniken Kassel |
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| OTHER |
| Klinikum Ludwigsburg | OTHER |
| Mathilden Hospital Herford | UNKNOWN |
| St. Franziskus Hospital Münster | UNKNOWN |
| Agaplesion Kliniken Kassel | UNKNOWN |
| Ovesco Endoscopy AG | INDUSTRY |
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| up to 4 weeks |
| 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 |
| Procedural parameters - Intervention duration | Intervention duration (time range from injection to complete resection) | 1 day |
| Procedural parameters - Cleanliness of the colon | Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9) | 1 day |
| Localization of polyp | Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum) | 1 day |
| Polyp size | Polyp diameter in mm | 1 day |
| Polyp morphology | according to paris classification | 1 day |
| Polyp histology | histological examination (tubular, tubulovillous, villous) | 7 days |
| Duration of hospital stay | Time frame from first day to discharge | up to 4 weeks |
| Kassel |
| 34119 |
| Germany |
| Klinikum Ludwigsburg | Ludwigsburg | 71640 | Germany |
| St. Franziskus Hospital Münster | Münster | 48145 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Rems-Murr-Klinikum Winnenden | Winnenden | 71364 | Germany |
| Universitätsklinik Würzburg | Würzburg | 97080 | Germany |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Stadtspital Waid | Zurich | 8037 | Switzerland |