NCT02885142

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3.6 years

First QC Date

August 26, 2016

Last Update Submit

November 17, 2025

Conditions

Anal Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas.

    3 years

Study Arms (2)

Transanal endoscopic microsurgery group

EXPERIMENTAL
Procedure: Local excision for early rectal cancer

endoscopic submucosal dissection group

ACTIVE COMPARATOR
Procedure: Local excision for early rectal cancer

Interventions

Local excision for early rectal cancerPROCEDURE
Transanal endoscopic microsurgery groupendoscopic submucosal dissection group

Eligibility Criteria

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

You may qualify if:

  • Presenting with an ERT (i.e. rectal adenoma or rectal carcinoma Tis or staged usT1N0 on endorectal ultrasound) that can be alternately resectable by TEM or ESD
  • Histology proved by a preoperative biopsy

You may not qualify if:

  • " Palliative " excision T2/3/4 or N+
  • Preoperative radiochemotherapy (down-staging)
  • Metastatic cancer
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Beyer-Berjot L, Delettrez C, Jacques J, Rouanet P, Chaussade S, Lefevre JH, Chabrun E, Koch S, Tuech JJ, Bridoux V, Rullier E, Denost Q, Panis Y, Maggiori L, Benoist S, Brouquet A, Barthet M, Gonzalez JM, Cotte E, Arquilliere J, Jafari M, Meurette G, Poincloux L, Zerbib P, Regimbeau JM, Sabbagh C, Prudhomme M, Legros R, Berdah S, Dervaux B, Boucekine M, Denies F, Rivory J, Baumstarck K, Pioche M, Lepilliez V. TEM OR ESD IN EARLY RECTAL TUMORS: A CLINICAL & COST-EFFECTIVENESS ANALYSIS. Gastroenterology. 2026 Jan 29:S0016-5085(26)00029-6. doi: 10.1053/j.gastro.2026.01.006. Online ahead of print.

    PMID: 41620037DERIVED

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

  • Laura BEYER, MD

    Assistance Publique Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

November 1, 2016

Primary Completion

June 11, 2020

Study Completion

August 24, 2022

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)