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| Name | Class |
|---|---|
| Hôpital Edouard Herriot | OTHER |
| Maria Sklodowska-Curie National Research Institute of Oncology | OTHER |
| Nuovo Regina Margherita Hospital | OTHER |
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Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery.
Co-primary endpoints are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Active Comparator | Patients randomized to surgery are treated according to current guidelines with either open, laparoscopic or robotic surgical segmental bowel resection corresponding to lymphovascular drainage of the cancer. |
|
| EFTR (Endoscopic Full-Thickness Resection) | Experimental | Patients randomised to EFTR are treated using devices approved for eFTR in the European Union and affiliated countries for the indication as applied in the trial. Before EFTR, the scar is identified and documented. The colonoscope is then removed, the EFTR device mounted, the colonoscope re-introduced, and eFTR performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor removal | Procedure | Removal of incompletely removed early-stage colon cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe adverse events | Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment | 30 days |
| CRC recurrence or sign of lymph nodes or distant metastases | Rate of CRC recurrence or sign of lymph nodes or distant metastases | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment | CRC recurrence or metastases | 1 year |
| CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Costs in dollars as compared to effectiveness | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nastazja Pilonis, MD PhD | Contact | +48787863649 | nastazja@gmail.com | |
| Michael Bretthauer, MD PhD | Contact | +4790132480 | michael.bretthauer@medisin.uio.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken Hospital | Recruiting | Oslo | Akershus | 1346 | Norway |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Karolinska Institutet |
| OTHER |
| Humanitas Clinical and Research Center | OTHER |
| Medical University of Gdansk | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| University Hospital, Akershus | OTHER |
| Vestre Viken Hospital Trust | OTHER |
| University Hospital of North Norway | OTHER |
| Helse Stavanger HF | OTHER_GOV |
| Oslo University Hospital | OTHER |
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CRC recurrence or metastases
| 5 years |
| CRC survival and overall survival at 1,3 and 5 years after study treatment | CRC survival and overall survival | 1, 3, 5 years |
| Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment | Severe adverse events | 1 year |
| Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment | mild and moderate adverse events | 30 days |
| Length of hospital stay after study treatment | Hospital stay | 30 days |
| Hospital readmission rate after discharge within 30 days after study treatment | Hospital readmission | 30 days |
| Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection | Technical success | 1 day |
| Duration of the study procedure | Duration of procedure | 1 day |
| Environmental footprint of study procedures at 30 days after study treatment | Carbon dioxide emission in kgCo2 per procedure | 30 days |
| Health related quality of life and functional outcomes after 30 days and one year | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (0-100 points; higher point scores mean higher QoL) | 30 days, 1 year |
| Akershus University Hospital | Recruiting | Oslo | Norway |
|
| Maria Sklodowska-Curie National Research Institute of Oncology | Recruiting | Warsaw | 02-781 | Poland |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |