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

NCT ID: NCT02885142

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-08-24

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.

Conditions

Anal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Transanal endoscopic microsurgery group

Group Type: EXPERIMENTAL

Local excision for early rectal cancer

Intervention Type: PROCEDURE

endoscopic submucosal dissection group

Group Type: ACTIVE_COMPARATOR

Local excision for early rectal cancer

Intervention Type: PROCEDURE

Interventions

Local excision for early rectal cancer

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Laura BEYER, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2016-A01363-48

Identifier Type: OTHER

Identifier Source: secondary_id

2016-33

Identifier Type: -

Identifier Source: org_study_id