ong term outcomes of Endoscopic Intermuscular Dissection for stage I rectal carcinomas
- Conditions
- T1 rectal cancer
- Registration Number
- NL-OMON24409
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 140
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
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Age < 18 years
-Unable to complete quality of life questionnaires at baseline and 1e follow-up, or sign informed consent
-Treatment of a AJCC stage III or IV CRC within the last 5 years
-A suspicious peri-rectal lymph node of > 9 mm on the preprocedural MRI.
-A T1 CRC extending above the sigmoid take-off on MRI
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>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. <br>
- Secondary Outcome Measures
Name Time Method 1)The quality of completion TME surgery after EID <br>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 <br>3)Technical success of the EID in achieving an en bloc resection through the intermuscular plane, leaving the longitudinal muscle layer intact<br>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.<br>5)All costs of the procedure will be recorded, as well as hospital stay, and re-intervention or re-admission for complications. <br>6)Quality of life (QLQ-C30, QLQ-C29, and EQ-5D-5L)<br>7)Functional outcome (COREFO and LARS score)<br>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. <br>