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Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? (MUCEM)

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ClinicalTrials.gov Identifier: NCT02885142
Recruitment Status : Not yet recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Anal Cancer Procedure: Local excision for early rectal cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transanal endoscopic microsurgery group Procedure: Local excision for early rectal cancer
Active Comparator: endoscopic submucosal dissection group Procedure: Local excision for early rectal cancer



Primary Outcome Measures :
  1. Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885142


Contacts
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Contact: laura BEYER, MD laura.beyer@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Laura Beyer, MD       laura.beyer@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
Principal Investigator: Laura BEYER, MD Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02885142     History of Changes
Other Study ID Numbers: 2016-33
2016-A01363-48 ( Other Identifier: Ansm )
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases