Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? (MUCEM)
Primary Purpose
Anal Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Local excision for early rectal cancer
Sponsored by
About this trial
This is an interventional other trial for Anal Cancer
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
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transanal endoscopic microsurgery group
endoscopic submucosal dissection group
Arm Description
Outcomes
Primary Outcome Measures
Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas.
Secondary Outcome Measures
Full Information
NCT ID
NCT02885142
First Posted
August 26, 2016
Last Updated
August 31, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02885142
Brief Title
Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?
Acronym
MUCEM
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
difficulties to recruit all the patients
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2022 (Actual)
Study Completion Date
August 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
337 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transanal endoscopic microsurgery group
Arm Type
Experimental
Arm Title
endoscopic submucosal dissection group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Local excision for early rectal cancer
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laura BEYER, MD
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?
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