Early Rectal CancerNCT03718351
Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
A study testing transanal endoscopic microsurgery and endoscopic submucosal dissection in people with Early Rectal Cancer and Large Rectal Adenomas, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Rectal Cancer, Large Rectal Adenomas
- What is being tested?
- transanal endoscopic microsurgery and endoscopic submucosal dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteRussia
- Study dates
- 24 Sep 2018to 24 Sep 2021
- 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
- The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
- Have signed approved informed consent form for the study
- preoperative stage uT0 and/or uT1, mrT0 and/or mrT1
Who cannot join
- non-epithelial tumors
- tumors </= 3 cm in size
- recurrent tumors
- suspicion of lymph node metastasis (N + disease)
- preoperative stage uT2 and/or mrT2
- mucous or low-grade adenocarcinoma
- preoperative stage rM1 and/or uM1
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
About this study
Official title: Randomized Controlled Trial of Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.
- Conditions
- Early Rectal Cancer, Large Rectal Adenomas
- Being tested
- transanal endoscopic microsurgery, endoscopic submucosal dissection
- Keywords
- Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal endoscopic microsurgeryProcedure or surgery
a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.
endoscopic submucosal dissectionProcedure or surgery
an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.
| Study group | Role | What they receive |
|---|---|---|
| transanal endoscopic microsurgery | Active comparator | a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital. Receives: Procedure: transanal endoscopic microsurgery |
| endoscopic submucosal dissection | Experimental | an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital. Receives: Procedure: endoscopic submucosal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Measured: 14 day
En-block resesction rate
Measured: 14 day
Secondary outcomes (2)
Incidence of locoregional recurrence
Measured: 12 months
Morbidity defined by the Clavien-Dindo classification
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start24 Sep 2018
- Primary completion24 Sep 2021 (estimated)
- Study completion24 Sep 2021 (estimated)
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 Early Rectal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718351
- Sponsor's protocol ID
- 104a
- Status last verified
- Dec 2019
- First submitted
- 24 Sep 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rybakov E, Chernyshov S, Likutov A, Khomiakov E, Yugai O, Alekseev M, Maynovskaia O, Tarasov M, Achkasov S. The results of randomized controlled trial comparing effectiveness of transanal endoscopic microsurgery versus endoscopic submucosal dissection. Surg Endosc. 2026 Jan;40(1):469-474. doi: 10.1007/s00464-025-12319-7. Epub 2025 Oct 24.
PubMed 41136652
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
- ClinicalTrials.gov ID
- NCT03718351
- Acronym / sponsor ID
- 104a
- Conditions
- Early Rectal Cancer, Large Rectal Adenomas
- Keywords
- Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 24 Sep 2021 (estimated)
- Study completion
- 24 Sep 2021 (estimated)
- First posted
- 24 Oct 2018 (actual)
- 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.
Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal endoscopic microsurgery | Active comparator | Procedure: transanal endoscopic microsurgerya TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital. |
| endoscopic submucosal dissection | Experimental | Procedure: endoscopic submucosal dissectionan endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
- Have signed approved informed consent form for the study
- preoperative stage uT0 and/or uT1, mrT0 and/or mrT1
Key exclusion criteria (7 listed)
- non-epithelial tumors
- tumors </= 3 cm in size
- recurrent tumors
- suspicion of lymph node metastasis (N + disease)
- preoperative stage uT2 and/or mrT2
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 |
|---|---|---|
| transanal endoscopic microsurgerya TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital. | Procedure or surgery | transanal endoscopic microsurgery |
| endoscopic submucosal dissectionan endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital. | Procedure or surgery | endoscopic submucosal dissection |
Primary outcome
R0 resection rate
Time frame: 14 day
En-block resesction rate
Time frame: 14 day
2 secondary outcomes
Incidence of locoregional recurrence
Time frame: 12 months
Morbidity defined by the Clavien-Dindo classification
Time frame: 30 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Derived from this study: PubMed 41136652Rybakov E, Chernyshov S, Likutov A, Khomiakov E, Yugai O, Alekseev M, Maynovskaia O, Tarasov M, Achkasov S. The results of randomized controlled trial comparing effectiveness of transanal endoscopic microsurgery versus endoscopic submucosal dissection. Surg Endosc. 2026 Jan;40(1):469-474. doi: 10.1007/s00464-025-12319-7. Epub 2025 Oct 24.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transanal endoscopic microsurgery and endoscopic submucosal dissection in people with Early Rectal Cancer and Large Rectal Adenomas, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Dec 2019. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanislav Chernyshov, MD (+7 499 199 86 43, stchernyshov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 14 day). The study lists 2 primary outcomes in all. 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 NCT03718351, 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 6 Dec 2019.