Rectal Neuroendocrine TumorNCT05429216
Endoscopic Resection for Small Rectal Neuroendocrine Tumors
A study testing mEMR-C procedure and ESD procedure in people with Rectal Neuroendocrine Tumor, run by Nanfang Hospital, Southern Medical University.
Trial summary
In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it… 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?
- mEMR-C 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
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2026
- 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 or colonoscopy;
- With tumor size ≤10 mm assessed by colonoscopy;
- Plan to receive mEMR-C or ESD treatment and provide written informed consent;
Who cannot join
- Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
- 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.
About this study
Official title: Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial
In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.
Read the detailed description
Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six tertiary hospitals in China.
- Conditions
- Rectal Neuroendocrine Tumor
- Being tested
- mEMR-C procedure, ESD procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mEMR-C procedureProcedure or surgery
A transparent cap with an inner groove (MH-593; Olympus, Tokyo, Japan) was attached to the forward-viewing colonoscope. After the endoscope was inserted into the rectum, a crescent-shaped electrosurgical snare was passed through the sheath and looped along the inner groove of the cap. Submucosal injections were not required in this method. The tumor was suctioned into the cap and grasped by tightening the snare. After confirming the appropriate snare placement, both the tumor and overlying mucosa were resected using electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and the resected tumor was sent for pathological examination. Endoscopic examination was repeated without a transparent cap to evaluate the wound carefully in cases of perforation or bleeding and to ensure the absence of residual tumor tissues. If there was spurting or active bleeding, hot forceps were used to stop the bleeding.
ESD procedureProcedure or surgery
ESD was performed as the standard procedure and has been widely described and used. First, dots were marked approximately 5 mm from the periphery of the lesion using coagulation. Subsequently, a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. Mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan). After resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding.
| Study group | Role | What they receive |
|---|---|---|
| mEMR-C group | Experimental | In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection. Receives: Procedure: mEMR-C procedure |
| ESD group | Active comparator | In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the 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 installation of the snare in the mEMR-C or the first submucosal injection in ESD 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
hospitalization cost
represent the hospital's costs of being hospitalized
Measured: within 14 days after procedure
operation cost
the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures
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 posted23 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2026 (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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429216
- Sponsor's protocol ID
- NFEC-2022-206
- Status last verified
- May 2022
- First submitted
- 17 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT05429216
- Acronym / sponsor ID
- NFEC-2022-206
- Conditions
- Rectal Neuroendocrine Tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jun 2022 (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.
In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.
Detailed description
Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six tertiary hospitals in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mEMR-C group | Experimental | Procedure: mEMR-C procedureIn mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection. |
| ESD group | Active comparator | Procedure: ESD procedureIn ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the 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 or colonoscopy;
- With tumor size ≤10 mm assessed by colonoscopy;
- Plan to receive mEMR-C or ESD treatment and provide written informed consent;
Key exclusion criteria (7 listed)
- Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
- 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 |
|---|---|---|
| mEMR-C procedureA transparent cap with an inner groove (MH-593; Olympus, Tokyo, Japan) was attached to the forward-viewing colonoscope. After the endoscope was inserted into the rectum, a crescent-shaped electrosurgical snare was passed through the sheath and looped along the inner groove of the cap. Submucosal injections were not required in this method. The tumor was suctioned into the cap and grasped by tightening the snare. After confirming the appropriate snare placement, both the tumor and overlying mucosa were resected using electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and the resected tumor was sent for pathological examination. Endoscopic examination was repeated without a transparent cap to evaluate the wound carefully in cases of perforation or bleeding and to ensure the absence of residual tumor tissues. If there was spurting or active bleeding, hot forceps were used to stop the bleeding. | Procedure or surgery | mEMR-C group |
| ESD procedureESD was performed as the standard procedure and has been widely described and used. First, dots were marked approximately 5 mm from the periphery of the lesion using coagulation. Subsequently, a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. Mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan). 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
hospitalization cost
Time frame: within 14 days after procedure
operation 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 1 Jul 2022.
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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 mEMR-C procedure and ESD procedure in people with Rectal Neuroendocrine Tumor, run by Nanfang Hospital, Southern Medical University.
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: opening soon, as of the sponsor's last update on 1 Jul 2022. 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?
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 1 Jul 2022.