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

State Scientific Centre of Coloproctology, Russian Federation

Status: Unknown

Conditions: Early Rectal Cancer; Large Rectal Adenomas

Treatments: Procedure: transanal endoscopic microsurgery; Procedure: endoscopic submucosal dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03718351

104a

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

transanal endoscopic microsurgery

Active Comparator group

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.

Treatment:

Procedure: transanal endoscopic microsurgery

endoscopic submucosal dissection

Experimental group

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.

Treatment:

Procedure: endoscopic submucosal dissection