T1 rectal cancer
Conditions
Interventions
Intermuscular dissection between the circular and longitudinal part of the m. propria of the rectum
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Adult patients with a suspected T1 CRC with deep submucosal invasion based on optical diagnosis, using JNET 3, NICO III or Hiroshima C2-C3 classification, or > 40% with the OPTICAL model. - A T1 rectal cancer located at or under the sigmoid take-off on the MRI - At least 5 mm between the dentate line and the carcinomatous part of the polyp - Written informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age 9 mm on the preprocedural MRI. - A T1 CRC extending above the sigmoid take-off on MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)The proportion of histology confirmed (R0) resections of deep submucosal (T1) invasive rectal carcinomas with R0 defined as a minimal of 0.1 mm tumor free deep resection margin 2)The 3 and 5 years recurrence rate defined as either a local regrowth, LNM during or distant metastasis during follow-up of an R0 resection of a T1 CRC without the histological risk factors lymphovascular invasion, tumor budding or poor differentiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The quality of completion TME surgery after EID 2) The proportion curative resections defined as an R0 resection without the histological risk factors lymphovascular invasion, poor (G3) differentiation and/or high grade (BD2-3) tumor budding 3) Technical success of the EID in achieving an en bloc resection through the intermuscular plane, leaving the longitudinal muscle layer intact 4) Adverse outcomes after EID defined by any EID related AE or mortality within 30 days. The AE will be recorded according the ASGE lexicon. 5) All costs of the procedure will be recorded, as well as hospital stay, and re-intervention or re-admission for complications. 6) Quality of life (QLQ-C30, QLQ-C29, and EQ-5D-5L) 7) Functional outcome (COREFO and LARS score) 8) Sensitivity, specificity, negative and positive predictive value will be determined of MRI for making the difference between T1 Sm2-3 versus T2, and nodal staging. | — |
Contacts
Public ContactLMG Moons
UMC Utrecht
Outcome results
None listed