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

Comparision of Safety and Efficacy Between Modified Double Snare Assisted EMR (mDS-EMR) and ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm: a Prospective Non-inferiority Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Neuroendocrine Tumors
• Intervention / Treatment: Procedure: endoscopic submucosal dissection; Procedure: modified double snare assisted endoscopic mucosal resection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESD; 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; 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.
Experimental: mDS-EMR; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete resection	Rate of complete en bloc resection with microscopically negative margins.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
En bloc resection	Rate of complete resection as a single piece	Day 30
operation success rate	Technical success was defined as the completion of procedure without abortion or conversion to other procedure	Periprocedural
operation time	Operation time of ESD refers to the period from marking to completely removing the lesion, including submucosal injection, circumferential incision, submucosal dissection, additional submucosal injection and hemostasis during the operation and closure of the wound. Operation time of mDS-EMR refers to the period from the placing of the external snare to completely removing the lesion, hemostasis and closure of the wound.	Periprocedural
Postoperative hospital stay	Period from the day of operation to discharge	through study completion, an average of 30 days
operation-related expenses	Consumables cost of mDS-EMR and ESD	through study completion, an average of 30 days
Average hospitalization expenses	All the expenses during the hospitalization period	through study completion, an average of 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed perforation	Postoperative abdominal pain, along with pelvic infection. Free gas in the pelvic cavity can be observed by imaging examination.	30 days after the operation
Delayed bleeding	Hemorrhage occurs withing 30 days after the procedure that requires endoscopic, radiological, or surgical intervention, or a blood transfusion may be required.	30 days after the operation
Intraoperative bleeding	arterial bleeding or active oozing for more than 30 seconds during the operation, which required endoscopic, radiological, or surgical intervention.	Intraoperative
Intraoperative perforation	Damage of muscular layer of rectal wall and a hole to extracavitary tissue can be observed by endoscopy.	Intraoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection; rectal neuroendocrine tumor
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Endoscopic Mucosal Resection
• Other Study ID Numbers: 2025-0755; 2025-LCYJ-MS-12 (Other Grant/Funding Number: the Affiliated Drum Tower Hospital of Nanjing University Medical School)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No