Anal CancerMUCEMNCT02885142
Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?
A study testing Local excision for early rectal cancer in people with Anal Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Local excision for early rectal cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- " Palliative " excision T2/3/4 or N+
- Preoperative radiochemotherapy (down-staging)
- Metastatic cancer
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Local excision for early rectal cancer
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local excision for early rectal cancerProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transanal endoscopic microsurgery group | Experimental | Not described Receives: Procedure: Local excision for early rectal cancer |
| endoscopic submucosal dissection group | Active comparator | Not described Receives: Procedure: Local excision for early rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startNov 2016
- Primary completion11 Jun 2020
- Study completion24 Aug 2022
Why it stopped: difficulties to recruit all the patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de MarseilleLaura BEYER, MD, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885142
- Sponsor's protocol ID
- 2016-33
- Other IDs
- 2016-A01363-48
- Acronym
- MUCEM
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2016
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Beyer-Berjot L, Delettrez C, Jacques J, Rouanet P, Chaussade S, Lefevre JH, Chabrun E, Koch S, Tuech JJ, Bridoux V, Rullier E, Denost Q, Panis Y, Maggiori L, Benoist S, Brouquet A, Barthet M, Gonzalez JM, Cotte E, Arquilliere J, Jafari M, Meurette G, Poincloux L, Zerbib P, Regimbeau JM, Sabbagh C, Prudhomme M, Legros R, Berdah S, Dervaux B, Boucekine M, Denies F, Rivory J, Baumstarck K, Pioche M, Lepilliez V. Transanal Endoscopic Microsurgery or Endoscopic Submucosal Dissection in Early Rectal Tumors: A Clinical and Cost-Effectiveness Analysis: The MUCEM Study. Gastroenterology. 2026 Jun;170(7):1533-1545. doi: 10.1053/j.gastro.2026.01.006. Epub 2026 Jan 29.
PubMed 41620037
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?
- ClinicalTrials.gov ID
- NCT02885142
- Acronym / sponsor ID
- MUCEM / 2016-33
- Conditions
- Anal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties to recruit all the patients
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal endoscopic microsurgery group | Experimental | Procedure: Local excision for early rectal cancer |
| endoscopic submucosal dissection group | Active comparator | Procedure: Local excision for early rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- " Palliative " excision T2/3/4 or N+
- Preoperative radiochemotherapy (down-staging)
- Metastatic cancer
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local excision for early rectal cancer | Procedure or surgery | Transanal endoscopic microsurgery group, endoscopic submucosal dissection group |
Primary outcome
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
Results and safety
The study was stopped early (reason given: difficulties to recruit all the patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 41620037Beyer-Berjot L, Delettrez C, Jacques J, Rouanet P, Chaussade S, Lefevre JH, Chabrun E, Koch S, Tuech JJ, Bridoux V, Rullier E, Denost Q, Panis Y, Maggiori L, Benoist S, Brouquet A, Barthet M, Gonzalez JM, Cotte E, Arquilliere J, Jafari M, Meurette G, Poincloux L, Zerbib P, Regimbeau JM, Sabbagh C, Prudhomme M, Legros R, Berdah S, Dervaux B, Boucekine M, Denies F, Rivory J, Baumstarck K, Pioche M, Lepilliez V. Transanal Endoscopic Microsurgery or Endoscopic Submucosal Dissection in Early Rectal Tumors: A Clinical and Cost-Effectiveness Analysis: The MUCEM Study. Gastroenterology. 2026 Jun;170(7):1533-1545. doi: 10.1053/j.gastro.2026.01.006. Epub 2026 Jan 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
Laura BEYER, MD principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local excision for early rectal cancer in people with Anal Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties to recruit all the patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02885142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.