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Spots Global Cancer Trial Database for Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?

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Trial Identification

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

Official Title:

Study ID: NCT02885142

Conditions

Anal Cancer

Study Description

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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Assistance Publique H么pitaux de Marseille, Marseille, , France

Contact Details

Name: Urielle DESALBRES

Affiliation: Assistance Publique H么pitaux de Marseille

Role: STUDY_DIRECTOR

Name: Laura BEYER, MD

Affiliation: Assistance Publique H么pitaux de Marseille

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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