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

NCT07373015 | Not Yet Recruiting DMC

• 2 other identifiers: 2025-07552025-LCYJ-MS-12
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rectal Neuroendocrine Tumors

Keywords

Endoscopic Submucosal Dissection; Endoscopic Mucosal Resection; rectal neuroendocrine tumor

Outcome Measures

Primary Outcomes (1)

• complete resection

  Rate of complete en bloc resection with microscopically negative margins.

  Day 30

Secondary Outcomes (6)

• En bloc resection

  Day 30

• operation success rate

  Periprocedural

• operation time

  Periprocedural

• Postoperative hospital stay

  through study completion, an average of 30 days

• operation-related expenses

  through study completion, an average of 30 days

Other Outcomes (4)

• Delayed perforation

  30 days after the operation

• Delayed bleeding

  30 days after the operation

• Intraoperative bleeding

  Intraoperative

Study Arms (2)

ESD

ACTIVE COMPARATOR

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.

Procedure: endoscopic submucosal dissection

mDS-EMR

EXPERIMENTAL

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.

Procedure: modified double snare assisted endoscopic mucosal resection

Interventions

modified double snare assisted endoscopic mucosal resection PROCEDURE

A polypectomy snare (resection snare) was placed outside of the endoscope. After approaching the lesion, a second polypectomy snare (capture snare) was inserted through the biopsy channel of the endoscope to grasp and lift the lesion. The snare preloaded outside of the endoscope was released, passed through the capture snare and positioned below the capture snare to grasp the base of the lesion. Once the lesion was securely grasped, it was resected by resection snare to achieve en bloc resection. The wounds were closed by clips.

mDS-EMR

endoscopic submucosal dissection PROCEDURE

The procedure includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife (such as Dual knife, Golden knife or Kunpeng knife, etc.) , hemostasis and sealing of the wound. Traction is allowed during the operation.

ESD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment.
• Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment.
• Patients can understand and sign the informed consent.

You may not qualify if:

• Poor coagulation function(PT\>15 seconds or APTT\>45 seconds or INR\>2.0)
• 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)
• Indication of metastasis by preoperative imaging examinations
• With more than or equal to 2 rectal neuroendocrine tumors
• With other complications that are not suitable for this study by multidisciplinary team assesment
• Cases of recurrence after operation for neuroendocrine tumors

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-12