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Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?

NCT02885142 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2025-11-18

No results posted yet for this study

Summary

Local excision for early rectal cancer has proven its feasibility and oncological safety. Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas respectively. Two procedures are currently performed in these early cancers as well as in preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its superiority over traditional transanal excision, is a surgical approach associated with a 92% R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It consists of a full-thickness excision. The second procedure is a recently introduced technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the subgroup of European series. Though very promising, the role of ESD remains controversial in malignant lesions with few published reports. There are therefore 2 different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve the same oncological treatment. So far, only one retrospective single-center study including 63 patients has compared TEM and ESD in early rectal cancer without finding any difference between the 2 procedures, and there are no other available studies comparing TEM and ESD for any type of colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal cancer and rectal adenomas for short- and long-term outcomes.

Conditions

Interventions

PROCEDURE

Local excision for early rectal cancer

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Urielle DESALBRES · Assistance Publique Hôpitaux de Marseille

  • Laura BEYER, MD · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-06-11
Completion
2022-08-24

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02885142 on ClinicalTrials.gov