Rectal Neuroendocrine TumorNCT07759960
Underwater Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Small Rectal Neuroendocrine Tumors
A study testing UEMR procedure and ESD procedure in people with Rectal Neuroendocrine Tumor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neuroendocrine Tumor
- What is being tested?
- UEMR procedure and ESD procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2026to Dec 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years;
- With a high suspicion or evidence of rectal NET assessed using EUS, CT scan or colonoscopy;
- With tumor size ≤10 mm assessed by colonoscopy or EUS;
- Plan to receive UEMR or ESD treatment and provide written informed consent.
Who cannot join
- Unable to tolerate ESD or UEMR as assessed by the research team;
- Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
- Rectal NET with lymph node metastasis or distant metastasis;
- Received resection of rectal neuroendocrine tumor by other surgical procedures;
- Multiple rectal neuroendocrine tumors;
- Vulnerable groups such as pregnant women or patients with mental disorders;
- Poor compliance, unable to cooperate with treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Underwater Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Small Rectal Neuroendocrine Tumors: A Prospective, Multicenter, Non-inferiority Trial
Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Therefore, we aimed to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET.
Read the detailed description
Researchers plan to conduct a prospective, multicenter, non-inferiority, randomized controlled trial to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET in ten endoscopic centers in China.
- Conditions
- Rectal Neuroendocrine Tumor
- Being tested
- UEMR procedure, ESD procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UEMR procedureProcedure or surgery
Small rectal NET will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3)needle injection of normal saline into the submucosa; (4) snaring the lesion and the surrounding mucosa; and (5) resection using electrocautery.
ESD procedureProcedure or surgery
Small rectal NET will be removed by endoscopic submucosal dissection. The ESD procedure included the following: (1) dots were marked approximately 5 mm from the periphery of the lesion using coagulation; (2) a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. (3) mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan); (4)after resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding.
| Study group | Role | What they receive |
|---|---|---|
| UEMR group | Experimental | In UEMR group, enrolled patients will receive UEMR to remove small rectal NET. Receives: Procedure: UEMR procedure |
| ESD group | Active comparator | In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove small rectal NET Receives: Procedure: ESD procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological complete resection
complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.
Measured: within 14 days after procedure
Secondary outcomes (8)
success rate of operation
the proportion of patients whose tumors were successfully resected in each group
Measured: intraoperative
en bloc resection
complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined
Measured: intraoperative
operation time
the time required to complete the procedure, was taken from the first submucosal injection to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation
Measured: intraoperative
complications
perforation or hemorrhage during or after operation.
Measured: within 14 days after procedure
length of stay
calculated from the day of admission to day of discharge
Measured: within 14 days after procedure
operation cost
the cost of UEMR or ESD procedures, except the cost of other endoscopic procedures
Measured: within 14 days after procedure
hospitalization cost
represent the hospital's costs of being hospitalized
Measured: within 14 days after procedure
histopathologic grade
NET grade 1, NET grade 2, NET grade 3, and NEC
Measured: within 14 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start14 Apr 2026
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neuroendocrine TumorStudies of the same condition, open and under way.
- 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
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, The Eighth Affiliated Hospital of Southern Medical University, ZhuHai Hospital, Shenzhen Longgang District People's Hospital, Jiangmen Central Hospital, Yangjiang People's Hospital, The Third People's Hospital of Huizhou, the Fifth Affiliated Hospital of Zunyi Medical University (Zhuhai), Ganzhou City People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759960
- Sponsor's protocol ID
- NFEC-2026-079
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Small Rectal Neuroendocrine Tumors: A Prospective, Multicenter, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07759960
- Acronym / sponsor ID
- NFEC-2026-079
- Conditions
- Rectal Neuroendocrine Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, The Eighth Affiliated Hospital of Southern Medical University, ZhuHai Hospital, Shenzhen Longgang District People's Hospital, Jiangmen Central Hospital, Yangjiang People's Hospital, The Third People's Hospital of Huizhou, the Fifth Affiliated Hospital of Zunyi Medical University (Zhuhai), Ganzhou City People's Hospital
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 Aug 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.
Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Therefore, we aimed to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET.
Detailed description
Researchers plan to conduct a prospective, multicenter, non-inferiority, randomized controlled trial to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET in ten endoscopic centers in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UEMR group | Experimental | Procedure: UEMR procedureIn UEMR group, enrolled patients will receive UEMR to remove small rectal NET. |
| ESD group | Active comparator | Procedure: ESD procedureIn ESD group, enrolled patients will receive the standard treatment modality of ESD to remove small rectal NET |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 75 years;
- With a high suspicion or evidence of rectal NET assessed using EUS, CT scan or colonoscopy;
- With tumor size ≤10 mm assessed by colonoscopy or EUS;
- Plan to receive UEMR or ESD treatment and provide written informed consent.
Key exclusion criteria (7 listed)
- Unable to tolerate ESD or UEMR as assessed by the research team;
- Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;
- Rectal NET with lymph node metastasis or distant metastasis;
- Received resection of rectal neuroendocrine tumor by other surgical procedures;
- Multiple rectal neuroendocrine tumors;
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 |
|---|---|---|
| UEMR procedureSmall rectal NET will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3)needle injection of normal saline into the submucosa; (4) snaring the lesion and the surrounding mucosa; and (5) resection using electrocautery. | Procedure or surgery | UEMR group |
| ESD procedureSmall rectal NET will be removed by endoscopic submucosal dissection. The ESD procedure included the following: (1) dots were marked approximately 5 mm from the periphery of the lesion using coagulation; (2) a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. (3) mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan); (4)after resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding. | Procedure or surgery | ESD group |
Primary outcome
histological complete resection
Time frame: within 14 days after procedure
complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.
8 secondary outcomes
success rate of operation
Time frame: intraoperative
en bloc resection
Time frame: intraoperative
operation time
Time frame: intraoperative
complications
Time frame: within 14 days after procedure
length of stay
Time frame: within 14 days after procedure
operation cost
Time frame: within 14 days after procedure
hospitalization cost
Time frame: within 14 days after procedure
histopathologic grade
Time frame: within 14 days after procedure
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UEMR procedure and ESD procedure in people with Rectal Neuroendocrine Tumor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Zelong Han, MD (+86 20-6278-7385, hanzelong2025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological complete resection (time frame: within 14 days after procedure). 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 12 Aug 2026.