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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Mathilden Hospital Herford
Herford, Germany
Agaplesion Diakonie Kliniken Kassel
Kassel, Germany
Klinikum Ludwigsburg
Ludwigsburg, Germany
St. Franziskus Hospital Münster
Münster, Germany
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
Time frame: after 14 days
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
Time frame: 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.
Time frame: 6 months
Procedural parameters - Intervention duration
Intervention duration (time range from injection to complete resection)
Time frame: 1 day
Procedural parameters - Cleanliness of the colon
Cleanliness of the colon (according to the Boston Bowel Preparation Scale (BBPS) 0-9)
Time frame: 1 day
Localization of polyp
Position of the polyp within the colon (Coecum, Ascendens, Transversum, Deschendens, Sigmoid, Rectum)
Time frame: 1 day
Polyp size
Polyp diameter in mm
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Universitätsklinikum Ulm
Ulm, Germany
Rems-Murr-Klinikum Winnenden
Winnenden, Germany
Universitätsklinik Würzburg
Würzburg, Germany
Inselspital Bern
Bern, Switzerland
Stadtspital Waid
Zurich, Switzerland
Time frame: 1 day
Polyp morphology
according to paris classification
Time frame: 1 day
Polyp histology
histological examination (tubular, tubulovillous, villous)
Time frame: 7 days
Duration of hospital stay
Time frame from first day to discharge
Time frame: up to 4 weeks