Status:
NOT_YET_RECRUITING
Simple Transanal Local Excision，Transanal Local Excision Following Radiotherapy Versus Total Mesorectum Excision for the Treatment of the Ultra-low T2N0M0 Rectal Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A randomized controlled clinical trial to compare the short and long term outcomes of simple transanal local excision，transanal local excision following radiotherapy or total mesorectal excision for t...
Detailed Description
Rectal cancer is one of the most common malignancy worldwide. Currently, surgery is the main treatment for stage I rectal cancer, which has good therapeutic effect. For ultra-low rectal cancer, transa...
Eligibility Criteria
Inclusion
- Preoperative pathology confirmed adenocarcinoma.
- Preoperative MRI or digital examination of tectum confirmed that the distances from the lower edge of the tumors to the anus were less than 5 cm.
- The mass is not fixed.
- Preoperative MRI and rectal EUS indicated that the tumor only invaded muscular layer (T2).
- No suspicious lymphatic metastasis or distant metastasis was found on preoperative high-resolution CT and MRI.
- American Society of Anesthesiologists(ASA) grade I-III.
- Informed consent.
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Exclusion
- Age\<18, or\>75.
- Have other cancer history.
- The pathology of rectal tumors is non-adenocarcinoma.
- Multiple primary colorectal tumors.
- Preoperative CT and MR showed that lymphatic metastasis and distant metastasis could be positive.
- Pregnant or lactating women.
- Patients with severe mental disorders.
- ASA score \> 3.
- Receive other cancer treatments (radiotherapy, chemotherapy).
- Complication with other intestinal diseases (FAP, HNPCC, active ulcerative colitis or Crohn's disease).
- The general situation is poor and there are other uncontrollable diseases.
- Preoperative tumor stage was not T2N0M0.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04098471
Start Date
December 1 2019
End Date
December 1 2026
Last Update
September 23 2019
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