Adenoma Colon, Adenoma Colon Polyp
Conditions
Keywords
endoscopic submucosal dissection, endoscopic en bloc resection, EndoTEM system, endoscopic portsystem, ESD
Brief summary
The goal of this clinical trial is to determine whether the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon is feasible and safe. The main questions it aims to answer are: * Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon feasible (i.e., does it enable complete resection of the polyp)? * Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon safe? Participants will: * be treated with the EndoTEM system during the endoscopic submucosal dissection of polyps in the distal colon. * answere questionnaires on fecal continence and quality of life before and after the intervention. * be treated following standard clinical procedures before, during and after the endoscopic removal.
Interventions
DEVICEEndoTEM resection platform and technique
EndoTEM is a flexible transanally introduced port system that allows the insertion of a second instrument alongside the flexible endoscope. A curved rigid grasping instrument has been developed, with a 2 cm long tip that can be rotated and angled in all directions.
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Ovesco Endoscopy AG
Tuebingen Scientific Medical GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Availability of written informed consent from the patient * Age \> 18 years * Adenoma or early carcinoma \> 2 cm in the rectum or distal sigmoid colon with indication for endoscopic en bloc resection using endoscopic submucosal dissection
Exclusion criteria
* Informed consent not possible (e.g., language barrier) * Stenoses or fistulas in the anal region * Distance to the anocutaneous line ≤ 2 cm * Distance to the anocutaneous line \> 20 cm * Individual medical assessment required for patients taking anticoagulant medication, in accordance with current ESGE guidelines * Pregnancy or breastfeeding * Vulnerable individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of the endoscopic resection | From the endoscopic resection to the follow-up endoscopy after 6 months. | Macroscopically complete resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | Assessed with a biopsy collected during the intervention. | Histological complete resection. |
| En bloc resection rate | Assessed during the intervention. | Endoscopic removal of the polyp in one intact piece, including any necessary surrounding tissue. |
| Duration of the procedure | From endoscope insertion until the end of procedure including supplementary and prophylactic interventions. | — |
| Resection time | From start of the resection until detachment of the specimen. | — |
| Resection speed | Assessed during the intervention. | Resected area per minute (mm²/min). |
| Periprocedural complications | Complications that occur during or immediately around the intervention (until 3-6 months post-intervention). | — |
| Requirement for surgical intervention | During the endoscopic submucosal dissection. | — |
| Rate of recurrence | Assessed during follow-up endoscopy 3-6 months post-intervention. | — |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORArthur Schmidt, Prof. Dr. med.
Robert Bosch Krankenhaus GmbH
Outcome results
None listed