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Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Primary Purpose

Early Rectal Cancer, Large Rectal Adenomas

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
transanal endoscopic microsurgery
endoscopic submucosal dissection
Sponsored by
State Scientific Centre of Coloproctology, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Rectal Cancer focused on measuring Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • State Scientific Centre of ColoproctologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

transanal endoscopic microsurgery

endoscopic submucosal dissection

Arm Description

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.

Outcomes

Primary Outcome Measures

R0 resection rate
En-block resesction rate

Secondary Outcome Measures

Incidence of locoregional recurrence
Morbidity defined by the Clavien-Dindo classification

Full Information

First Posted
September 24, 2018
Last Updated
December 5, 2019
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT03718351
Brief Title
Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
September 24, 2021 (Anticipated)
Study Completion Date
September 24, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Rectal Cancer, Large Rectal Adenomas
Keywords
Transanal endoscopic microsurgery, Endoscopic submucosal dissection, Minimally invasive surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transanal endoscopic microsurgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
endoscopic submucosal dissection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
transanal endoscopic microsurgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
endoscopic submucosal dissection
Intervention Description
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.
Primary Outcome Measure Information:
Title
R0 resection rate
Time Frame
14 day
Title
En-block resesction rate
Time Frame
14 day
Secondary Outcome Measure Information:
Title
Incidence of locoregional recurrence
Time Frame
12 months
Title
Morbidity defined by the Clavien-Dindo classification
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanislav Chernyshov, MD
Phone
+7 499 199 86 43
Email
stchernyshov@gmail.com
Facility Information:
Facility Name
State Scientific Centre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

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