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

Early Rectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03718351
• Other study ID #: 104a
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: September 24, 2021

Study information

• Verified date: December 2019
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Stanislav Chernyshov, MD
• Phone: +7 499 199 86 43
• Email: stchernyshov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Early Rectal Cancer
• Large Rectal Adenomas
• Neoplasms
• Rectal Neoplasms

Intervention

Procedure:
• transanal endoscopic microsurgery
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 dissection
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.

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate		14 day
Primary	En-block resesction rate		14 day
Secondary	Incidence of locoregional recurrence		12 months
Secondary	Morbidity defined by the Clavien-Dindo classification		30 day