Rectal Neuroendocrine TumorsNCT07373015
Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm
A study testing modified double snare assisted endoscopic mucosal resection and endoscopic submucosal dissection in people with Rectal Neuroendocrine Tumors, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Neuroendocrine Tumors
- What is being tested?
- modified double snare assisted endoscopic mucosal resection and endoscopic submucosal dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official 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
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.
Read the 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.
- Conditions
- Rectal Neuroendocrine Tumors
- Being tested
- modified double snare assisted endoscopic mucosal resection, endoscopic submucosal dissection
- Keywords
- Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection, rectal neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified double snare assisted endoscopic mucosal resectionProcedure or surgery
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 dissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: modified double snare assisted endoscopic mucosal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection
Rate of complete en bloc resection with microscopically negative margins.
Measured: Day 30
Secondary outcomes (6)
En bloc resection
Rate of complete resection as a single piece
Measured: Day 30
operation success rate
Technical success was defined as the completion of procedure without abortion or conversion to other procedure
Measured: 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.
Measured: Periprocedural
Postoperative hospital stay
Period from the day of operation to discharge
Measured: through study completion, an average of 30 days
operation-related expenses
Consumables cost of mDS-EMR and ESD
Measured: through study completion, an average of 30 days
Average hospitalization expenses
All the expenses during the hospitalization period
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373015
- Sponsor's protocol ID
- 2025-0755
- Other IDs
- 2025-LCYJ-MS-12
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07373015
- Acronym / sponsor ID
- 2025-0755
- Conditions
- Rectal Neuroendocrine Tumors
- Keywords
- Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection, rectal neuroendocrine tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD | Active comparator | Procedure: endoscopic submucosal dissectionThe 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. |
| mDS-EMR | Experimental | Procedure: modified double snare assisted endoscopic mucosal resectionModified 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified double snare assisted endoscopic mucosal resectionA 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. | Procedure or surgery | mDS-EMR |
| endoscopic submucosal dissectionThe 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. | Procedure or surgery | ESD |
Primary outcome
complete resection
Time frame: Day 30
Rate of complete en bloc resection with microscopically negative margins.
6 secondary outcomes
En bloc resection
Time frame: Day 30
operation success rate
Time frame: Periprocedural
operation time
Time frame: Periprocedural
Postoperative hospital stay
Time frame: through study completion, an average of 30 days
operation-related expenses
Time frame: through study completion, an average of 30 days
Average hospitalization expenses
Time frame: through study completion, an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing modified double snare assisted endoscopic mucosal resection and endoscopic submucosal dissection in people with Rectal Neuroendocrine Tumors, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete resection (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.