Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm

Nanjing University

Status: Not yet enrolling

Conditions: Rectal Neuroendocrine Tumors

Treatments: Procedure: endoscopic submucosal dissection; Procedure: modified double snare assisted endoscopic mucosal resection

Study type: Interventional

Funder types: Other

Identifiers

NCT07373015

2025-0755

2025-LCYJ-MS-12 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this study is evaluating and safety and efficacy between the modified double snare EMR and ESD. It is intended to prove that for rectal neuroendocrine tumors within 1 cm, the complete resection rate of the mDS-EMR is not inferior to that of ESD, but may with shorter operation time, lower complication rate and lower treatment cost.

Full description

A prospective, single-center, randomized controlled non-inferiority trial was designed to compare the safety and efficacy of modified double snare EMR (mDS-EMR) with endoscopic submucosal dissection (ESD) for the resection of rectal neuroendocrine tumors. The study have 4 main research contents. 1, Whether the resection effect of mDS-EMR is not inferior to that of ESD, and the treatment effect is evaluated by the complete resection rate (R0 resection rate). 2, Whether the operation time of mDS-EMR is significantly shorter than that of ESD. 3, To compare the safety between mDS-EMR and ESD, and whether the mDS-EMR can reduce the risk of intraoperative and postoperative adverse events. 4, To compare the postoperative hospital stay, surgical costs and hospitalization costs between mDS-EMR and ESD.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Typical rectal neuroendocrine tumors by endoscopy (within 15cm from the anal verge, yellowish subepithelial elevation with a smooth surface, and dilated blood vessels in some areas).
2. The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment.
3. Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment.
4. Patients can understand and sign the informed consent.

Exclusion criteria

1. Poor coagulation function(PT>15 seconds or APTT>45 seconds or INR>2.0)
2. With severe cardiovascular or cerebrovascular diseases and cannot tolerate operation( with a history of stroke or myocardial infarction within the past month or with severe heart failure and cardiac function grade III)
3. Indication of metastasis by preoperative imaging examinations
4. With more than or equal to 2 rectal neuroendocrine tumors
5. With other complications that are not suitable for this study by multidisciplinary team assesment
6. Cases of recurrence after operation for neuroendocrine tumors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

118 participants in 2 patient groups

ESD

Active Comparator group

Description:

The traditional ESD treatment method is adopted, which includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife, hemostasis and cliping of the wound. Traction is allowed during the operation.

Treatment:

Procedure: endoscopic submucosal dissection

mDS-EMR

Experimental group

Description:

Modified double snare assisted EMR was used for treatment. Put the first snare for resecting outside the endoscope body. Then put the second snare at the base through the channel to tighten the lesion. Finally, place the first snare below the second one to tighten the lesion and perform electrically-assisted removal. Then, metal clips will be used to close the wound.

Treatment:

Procedure: modified double snare assisted endoscopic mucosal resection