NCT04098471

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Oct 2021Jun 2030

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

July 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

September 19, 2019

Last Update Submit

July 25, 2026

Conditions

Rectal Cancer

Keywords

transanal endoscopic microsurgeryT2N0M0

Outcome Measures

Primary Outcomes (1)

  • local recurrance rate

    3 years

Secondary Outcomes (14)

  • 3-years overall survival rate

    3 years

  • 3-year disease-free survival

    3 years

  • 3-year mortality rate

    3 years

  • postoperative quality of life

    30 days

  • complication rate

    30 days

  • +9 more secondary outcomes

Study Arms (2)

transanal endoscopic microsurgery followed by radiotherapy

EXPERIMENTAL
Procedure: transanal local excision following radiotherapy

total mesorectal excision

ACTIVE COMPARATOR
Procedure: TME

Interventions

transanal local excision following radiotherapyPROCEDURE

transanal local excision following radiotherapy

transanal endoscopic microsurgery followed by radiotherapy
TMEPROCEDURE

Total mesorectal excision

total mesorectal excision

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (1)

  • Tang 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: 35178428DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Yueming Sun, PhD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Yueming Sun, PhD

CONTACT

02568306026jssym@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

October 1, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2030

Last Updated

July 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)