endoscopic full thickness resection colorectal polyp T1 colorectal cancer colonoscopy
Conditions
Interventions
None listed
Sponsors
Amsterdam University Medical Center, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be invited for participation in the study: - Recent polypectomy/(p)EMR/ESD of T1 CRC without the following histological high-risk features*: o Poor differentiation o Lymphovascular invasion (NB if lymphovascular invasion cannot be assessed, patients are NOT eligible for inclusion) o Tumor budding grade 2/3 (NB if tumor budding cannot be assessed at histopathology, patients are NOT eligible for inclusion) - This recent polypectomy/(p)EMR/ESD for T1 CRC resulted in positive resection margins < 0.1mm (R1) or indeterminate resection margins (Rx) - The resection scar after polypectomy/EMR/ESD is clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colonic segment where no other polypectomies were performed - The diameter of the original lesion was = 30 mm - The diameter of the scar and/or residual lesion = 15 mm - The interval between index polypectomy/EMR and additional eFTR is at most 12 weeks - Staging computed tomography (CT) of thorax and abdomen is performed and no local lymph node or distant metastases are detected. In case of rectal location an additional magnetic resonance imaging (MRI) of the pelvis is performed and no local suspicious lymph node(s) detected. If the target lesion is visible on MRI, rectal location is defined as location distal from the sigmoid take off. If not visible on MRI, rectal location is defined as < 15 cm from anal verge on endoscopy. - Written informed consent is provided *Before inclusion in this study, eligible histology needs to be centrally revised by an expert gastrointestinal pathologist (either Dr. M. Lacle University Medical Center Utrecht or Dr. A. Farina Sarasqueta Amsterdam UMC). In case of any doubt on the presence of high-risk features, both expert pathologist will have a case discussion in order to make a statement on either the presence of these risk features or the indetermination of those.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from participation in this study: - If lymphovascular invasion and/or tumor budding grade 2/3 cannot be assessed after prior polypectomy/(p)EMR, patients are NOT eligible for inclusion - The patient is known with at least one of the following conditions: o Active inflammatory bowel disease (IBD) in the colon o Synchronous advanced CRC (defined as CRC in the 5 years before detection of T1 CRC, or elsewhere in the colorectum at the time of detection of T1 CRC) - Index lesion located < 5 cm of the anal verge or with involvement of the valvula Bauhini or appendiceal orifice - Age < 18 years - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the 2- and 5- year local luminal tumor recurrence rate after scar resection by eFTR following a previous potentially incomplete resection of low-risk T1 CRC | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the feasibility of completion eFTR, defined as a macroscopic complete en bloc scar excision in >80% of cases. 2. To assess the percentage of curative eFTR resections, defined as no residual cancer in the scar or in case any residual cancer a R0 resection for T1 CRC without high-risk features (poor differentiation, lymphovasular invasion and/or high-grade tumor budding (grade 2 or 3)). 3. To assess the presence of scar tissue and/or complete scar excision at histopathology 4. To assess the procedure-related adverse event rate and safety of eFTR compared to oncologic surgery in a historical patient-cohort for T1 CRC 5. To assess the 2- and 5- year locoregional nodal and/or distant tumor recurrence rate 6. To assess the 5-year disease-specific survival rate and overall survival rate 7. To assess the 2- and 5-year luminal, nodal and distant tumor recurrence rate in patients not meeting our inclusion criteria, but who did undergo eFTR completion treatment followed by strict surveillance | — |
Contacts
Public ContactBarbara Bastiaansen
Amsterdam UMC, location AMC
Outcome results
None listed