Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
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.
1 other identifier
interventional
236
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedStudy Start
First participant enrolled
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2021
CompletedDecember 6, 2019
December 1, 2019
3 years
September 24, 2018
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
R0 resection rate
14 day
En-block resesction rate
14 day
Secondary Outcomes (2)
Incidence of locoregional recurrence
12 months
Morbidity defined by the Clavien-Dindo classification
30 day
Study Arms (2)
transanal endoscopic microsurgery
ACTIVE COMPARATORa 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
EXPERIMENTALan 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Scientific Centre of Coloproctology
Moscow, 123423, Russia
Related Publications (1)
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.
PMID: 41136652DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation
Study Record Dates
First Submitted
September 24, 2018
First Posted
October 24, 2018
Study Start
September 24, 2018
Primary Completion
September 24, 2021
Study Completion
September 24, 2021
Last Updated
December 6, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share