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History of Changes for Study: NCT02885142
Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? (MUCEM)
Latest version (submitted August 26, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 26, 2016 None (earliest Version on record)
Comparison Format:

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Study NCT02885142
Submitted Date:  August 26, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2016-33
Brief Title: Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? (MUCEM)
Official Title:
Secondary IDs: 2016-A01363-48 [Ansm]
Open or close this module Study Status
Record Verification: August 2016
Overall Status: Unknown status [Previously: Not yet recruiting]
Study Start: November 2016
Primary Completion: November 2019 [Anticipated]
Study Completion: November 2020 [Anticipated]
First Submitted: August 26, 2016
First Submitted that
Met QC Criteria:
August 26, 2016
First Posted: August 31, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 26, 2016
Last Update Posted: August 31, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Assistance Publique Hopitaux De Marseille
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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:
Open or close this module Conditions
Conditions: Anal Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Urielle DESALBRES
Study Director
Assistance Publique Hôpitaux de Marseille
Laura BEYER, MD
Principal Investigator
Assistance Publique Hôpitaux de Marseille
Locations: France
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354
Contact:Contact: Laura Beyer, MD laura.beyer@ap-hm.fr
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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