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

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03718351
• Collaborator: (none)
• Enrollment: 236
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 6.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Early Rectal Cancer; Large Rectal Adenomas	Procedure: transanal endoscopic microsurgery; Procedure: endoscopic submucosal dissection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Sep 24, 2018
• Anticipated Primary Completion Date: Sep 24, 2021
• Anticipated Study Completion Date: Sep 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. R0 resection rate [14 day]

2. En-block resesction rate [14 day]

Secondary Outcome Measures

1. Incidence of locoregional recurrence [12 months]

2. Morbidity defined by the Clavien-Dindo classification [30 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Scientific Centre of Coloproctology	Moscow		Russian Federation	123423

Sponsors and Collaborators

• State Scientific Centre of Coloproctology, Russian Federation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rybakov Evgeny, MD, Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation, State Scientific Centre of Coloproctology, Russian Federation
• ClinicalTrials.gov Identifier: NCT03718351
• Other Study ID Numbers: 104a
• First Posted: Oct 24, 2018
• Last Update Posted: Dec 6, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rybakov Evgeny, MD, Dr. Med. Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation, State Scientific Centre of Coloproctology, Russian Federation: Transanal endoscopic microsurgery; Endoscopic submucosal dissection; Minimally invasive surgery
• Additional relevant MeSH terms: Neoplasms; Rectal Neoplasms; Adenoma

Study Results

No Results Posted as of Dec 6, 2019