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| Name | Class |
|---|---|
| Medical University of Gdansk | OTHER |
| Vestre Viken Hospital Trust | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Institute of Oncology in Warsaw |
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The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eFTR | Experimental | endoscopic full thickness resection |
|
| Surgery | Active Comparator | standard-of-care surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eFTR | Procedure | endoscopic full thickness resection |
| |
| Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of severe adverse events, re-admissions and deaths within 30 days | co-primary short-term endpoint is the composite rate of rate of severe adverse events, re-admissions and deaths within 30 days following assigned treatment | 30 days |
| Rate of cancer recurrence or CRC death after three years | primary long-term endpoint of CRC death or cancer recurrence or sign of lymph nodes or distant metastases after three years | 3 years |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MICHAEL BRETTHAUER, MD PhD | Contact | +4790132480 | michael.bretthauer@medisin.uio.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdańsk | Recruiting | Gdansk | Poland |
Only if ethical approval is granted by the other researchers, and the study scientific board has reviewed and approved the proposal
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| UNKNOWN |
| Karolinska Institutet | OTHER |
| University Hospital, Limoges | OTHER |
| University Hospital, Akershus | OTHER |
| University of Roma La Sapienza | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Leuven University Medical Center | UNKNOWN |
| University Hospital, Ghent | OTHER |
| Sorlandet Hospital HF | OTHER_GOV |
| Northern Norway Regional Health Trust | UNKNOWN |
| Helse Stavanger HF | OTHER_GOV |
| Haukeland University Hospital | OTHER |
| St. Olavs Hospital | OTHER |
| University of Oslo | OTHER |
| Frontier Science Foundation | UNKNOWN |
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| Procedure |
standard-of-care surgery |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |