Clinical trial · Interventional
Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer
Total Mesorectal Excision Versus Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: a Multicenter Randomized Trial
NCT04098471CI-TRIAL-00119520recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TME | Procedure | — | UNRESOLVED |
| transanal local excision following radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- transanal endoscopic microsurgery followed by radiotherapy
- interventionNames
- Procedure: transanal local excision following radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- total mesorectal excision
- interventionNames
- Procedure: TME
Primary outcomes (1)
- measure
- local recurrance rate
- timeFrame
- 3 years
Secondary outcomes (14)
- measure
- 3-years overall survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75 years. * Histologically confirmed adenocarcinoma by preoperative biopsy. * Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy. * Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination. * Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI. * No radiological evidence of suspicious lymph node metastasis or distant metastasis on preoperative contrast-enhanced computed tomography (CT) and MRI. * Ability to provide written informed consent. Exclusion Criteria: * History of other malignant tumors within the past 5 years. * Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination. * Multiple primary colorectal tumors. * Pregnant or breastfeeding women. * Patients with plans for pregnancy. * Severe psychiatric disorders. * Previous treatment for rectal cancer, including radiotherapy or chemotherapy. * Concomitant intestinal diseases, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active ulcerative colitis, or Crohn's disease. * Poor general condition or uncontrolled serious comorbidities that may affect study participation or treatment. * Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum. * Current participation in another clinical trial.
References
Publications (1)
- DERIVEDTang J, Zhang Y, Zhang D, Zhang C, Jin K, Ji D, Peng W, Feng Y, Sun Y. Total Mesorectal Excision vs. Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: A Multicenter Randomized Trial. Front Surg. 2022 Feb 1;9:812343. doi: 10.3389/fsurg.2022.812343. eCollection 2022. PMID 35178428