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NCT Number: NCT07373015

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

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.

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Key information

Conditions

Rectal Neuroendocrine Tumors

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. complete resection

    Time frame: Day 30

    Rate of complete en bloc resection with microscopically negative margins.

Secondary outcomes

  1. En bloc resection

    Time frame: Day 30

    Rate of complete resection as a single piece

  2. operation success rate

    Time frame: Periprocedural

    Technical success was defined as the completion of procedure without abortion or conversion to other procedure

  3. operation time

    Time frame: Periprocedural

    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.

  4. Postoperative hospital stay

    Time frame: through study completion, an average of 30 days

    Period from the day of operation to discharge

  5. operation-related expenses

    Time frame: through study completion, an average of 30 days

    Consumables cost of mDS-EMR and ESD

  6. Average hospitalization expenses

    Time frame: through study completion, an average of 30 days

    All the expenses during the hospitalization period

Other outcomes

  1. Delayed perforation

    Time frame: 30 days after the operation

    Postoperative abdominal pain, along with pelvic infection. Free gas in the pelvic cavity can be observed by imaging examination.

  2. Delayed bleeding

    Time frame: 30 days after the operation

    Hemorrhage occurs withing 30 days after the procedure that requires endoscopic, radiological, or surgical intervention, or a blood transfusion may be required.

  3. Intraoperative bleeding

    Time frame: Intraoperative

    arterial bleeding or active oozing for more than 30 seconds during the operation, which required endoscopic, radiological, or surgical intervention.

  4. Intraoperative perforation

    Time frame: Intraoperative

    Damage of muscular layer of rectal wall and a hole to extracavitary tissue can be observed by endoscopy.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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