early-stage rectal cancer early-stage rectal cancer
Conditions
Interventions
EID, an endoscopic technique which aims to dissect in between the inner (circular) and outer (longitudinal) part of the m. propria using a flexible endoscope, leaving the outer rectal wall layers inta
USUAL CARE/COMPARISON 
TAMIS, a minimally invasive surgical technique in which a transanal platform is used to allow access with laparoscopic instruments through the anus. The procedure is performed under general anesthesia
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients (18 years or older) with early-stage rectal cancer with optical suspicion for deep submucosal invasion, without evidence of lymph node metastasis, tumour deposis and/or extramural venous invasion on rectal MRI (cT1-2N0).
Exclusion criteria
Exclusion criteria: Patients are excluded if lesions involve more than 50% of the circumference or exceed 6 cm in size, or if there have been prior endoscopic or surgical resection attempts of the tumor. Further exclusion criteria include recurrent cancer after previous local resection, severe pre-existing fecal incontinence with impaired quality of life, inflammatory bowel disease with previous rectal inflammation, prior pelvic irradiation or neoadjuvant therapy, and AJCC stage II-IV colorectal cancer within the past 5 years or synchronous colorectal cancer. Additionally, patients are excluded if they have concomitant malignancies or other severe medical conditions likely to result in death within 5 years, poor general health preventing the use of general anesthesia, inability or contraindication to undergo MRI, inability to complete questionnaires or provide informed consent, and known pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is complete (R0) resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include:Procedure-related adverse events within 30 days (Clavien Dindo [TAMIS] or AGREE classifications [EID]), post-procedural pain (visual analogue scale) and recovery scores up to 30 daysCurative local excisions for pT1 sm2-3 rectal cancer (R0 resection without histological risk factors)Concordance between the definitive dissection plane and the initially intended dissection plane prior to local excision (e.g., presence of longitudinal m. propria following an intended intermuscular dissection).Quality of LE specimen (fragmentation, margin assessment, presence of m. propria underneath the invasive front (circular/longitudinal))Quality of completion surgery after EID vs TAMIS, including assessment of TME specimen quality (according to Quirke), conversion to laparotomy, 30-day adverse event (per Clavien-Dindo classification), and non-restorative procedures.Three-year intramural, locoregional (intramural + locoregional LNM) and distant recurrenceThree-year disease-specific and overall survivalHealth related QoL using the validated QLQ-C30, QLQ-C29, and EQ-5D-5L surveys at baseline, 1, 3, 12, and 36 monthsFunctional outcomes using the validated LARS score at baseline, 1, 3, 6, and 12 monthsRectal preservation and stoma free survival at three yearsHealthcare costs using the validated iMCQ and iPCQ questionnaires at 1, 3, 12 and 36 months. | — |
Countries
Netherlands
Contacts
Public ContactSC Albers
Amsterdam UMC
Outcome results
None listed