Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer

July 25, 2026 updated by: Yueming Sun, The First Affiliated Hospital with Nanjing Medical University

Total Mesorectal Excision Versus Transanal Endoscopic Microsurgery Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer: a Multicenter Randomized Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, transanal endoscopic microsurgery (TEM) has many advantages over total mesorectal excision (TME), such as less trauma, shorter hospitalization time, lower incidence of complications, protection of sexual function and protection of anal function. At present, transanal local excision has become the recommended operation for the T1N0M0 rectal cancer. However, the risk of lymph node metastasis still occurs in stage I tumors, especially in stage T2 tumors, the lymph node metastasis rate can reach 12% - 29% according to the literature. Salvage TME or chemoradiotherapy should be considered for the presence of positive margin of incision, lymphatic/vascular invasion and poor histological differentiation after transanal local excision. At present, the investigators have consulted a large number of literatures and found that TEM is still lack of sufficient evidence in the treatment of T2N0M0 ultra-low rectal cancer. Some studies believed that local excision combined with adjuvant therapy is safe and reliable, but the evidence is not enough. For ultra-low T2N0M0 rectal cancer, more studies need to be carried out to provide guidance for clinical treatment.

In this study, eligible patients will be randomly allocated to operative operation for rectal cancer either by TEM following radiotherapy or TME. 3-years local recurrence rate, 3-years disease free survival rate and 3-years overall survival rate，and postoperative quality of life will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University
        • Contact:
          • Yueming Sun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transanal endoscopic microsurgery followed by radiotherapy
Procedure: transanal local excision following radiotherapy
transanal local excision following radiotherapy
Active Comparator: total mesorectal excision
Procedure: TME
Total mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local recurrance rate
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival
Time Frame: 3 years
3 years
complication rate
Time Frame: 30 days
30 days
3-year mortality rate
Time Frame: 3 years
3 years
3-years overall survival rate
Time Frame: 3 years
3 years
postoperative quality of life
Time Frame: 30 days
Measured by Quality of Life Questionnaire "EORTC QLQ-C30 (version 3)"
30 days
perioperative mortality
Time Frame: 30 days
30 days
R0 resection rate
Time Frame: 7 days
7 days
operative time
Time Frame: 7 days
7 days
Intraoperative blood loss
Time Frame: 7 days
7 days
colostomy rate
Time Frame: 7 days
7 days
intraoperative blood transfusion
Time Frame: 7 days
7 days
intestinal exhaust time
Time Frame: 7 days
7 days
postoperative pain
Time Frame: 30 days after treatment
Postoperative pain was assessed by numerical rating scale (NRS). The pain level is divided into 0 to 10 points, with higher scores indicating stronger pain. 0 point represented painless, 10 point represented severe pain.
30 days after treatment
hospital stay
Time Frame: 30 days after treatment
30 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Director: Yueming Sun, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRSYM201909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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