Rectal Neuroendocrine TumorNCT03982264
Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
A study testing ESD procedure and EMR-C procedure in people with Rectal Neuroendocrine Tumor, run by Nanfang Hospital, Southern Medical University.
Trial summary
Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. 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?
- ESD procedure and EMR-C procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2019to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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;
- Definite diagnosis of rectal NET less than 10mm;
- Patients plan to receive either EMR-C or ESD treatment.
Who cannot join
- Serious comorbid diseases such as advanced malignant tumor and organ failure;
- Patients received conventional EMR, snare electrotomy and no treatment;
- Rectal NET with metastasis;
- Pregnant patient;
- Poor compliance
About this study
Official title: Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.
- Conditions
- Rectal Neuroendocrine Tumor
- Being tested
- ESD procedure, EMR-C procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESD procedureProcedure or surgery
ESD were all performed as the standard procedure that has been widely described and used. A diluted sodium hyaluronate solution was injected submucosally. Mucosal incision and submucosal dissection were performed by using either Hook knife (Olympus Medical, Japan) or a dual-knife (Olympus Medical, Japan) . After the resection was finished, all of the visible vessels on the artificial ulcer bed were thoroughly coagulated with argon plasma coagulation to prevent postoperative bleeding.
EMR-C procedureProcedure or surgery
A transparent cap (MH-593; Olympus) was attached to the forward-viewing endoscope. After the endoscope was inserted to the rectum, the snare passed through the sheath and was looped along the inner lip of the cap. The tumor was then suctioned into the cap and the snare was pushed off and closed. After confirming the appropriate snare placement, both the tumor and the overlying mucosa were resected by electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and then the removed tumor was sent for pathological examination. Endoscopic examination then was repeated without the transparent cap in order to evaluate the wound carefully in case there was any perforation or bleeding and to ensure the absence of the residual tumor tissues. If there was spurting bleeding or active bleeding, hot forceps were usually to stop the bleeding.
| Study group | Role | What they receive |
|---|---|---|
| ESD group | Active comparator | In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET Receives: Procedure: ESD procedure |
| EMR-C group | Experimental | In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET Receives: Procedure: EMR-C procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection rate(R0 rate)
Complete resection was defined as negative horizontal and vertical margins of specimen.
Measured: within 14 days after procedure
Secondary outcomes (5)
operating time
the time from endoscope in to endoscope out
Measured: intraoperative
complications rate
Complications were defined as 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
recurrence rate
a new rectal NET recurred confirmed by endoscopy and EUS
Measured: one year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start20 Jun 2019 (estimated)
- Primary completion20 Dec 2020 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 90 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
- NCT03982264
- Sponsor's protocol ID
- NFEC-2017-077
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao X, Huang S, Wang Y, Peng Q, Li W, Zou Y, Han Z, Cai J, Luo Y, Ye Y, Li A, Bai Y, Chen Y, Liu S, Li Y. Modified Cap-Assisted Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Rectal Neuroendocrine Tumors </=10 mm: A Randomized Noninferiority Trial. Am J Gastroenterol. 2022 Dec 1;117(12):1982-1989. doi: 10.14309/ajg.0000000000001914. Epub 2022 Aug 23.
PubMed 36455222
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm
- ClinicalTrials.gov ID
- NCT03982264
- Acronym / sponsor ID
- NFEC-2017-077
- Conditions
- Rectal Neuroendocrine Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- 20 Dec 2020 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 11 Jun 2019 (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.
Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD group | Active comparator | Procedure: ESD procedureIn ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET |
| EMR-C group | Experimental | Procedure: EMR-C procedureIn EMR-C group, enrolled patients will receive the treatment modality of EMR-C 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 (3 listed)
- Age from 18 to 75 years;
- Definite diagnosis of rectal NET less than 10mm;
- Patients plan to receive either EMR-C or ESD treatment.
Key exclusion criteria (5 listed)
- Serious comorbid diseases such as advanced malignant tumor and organ failure;
- Patients received conventional EMR, snare electrotomy and no treatment;
- Rectal NET with metastasis;
- Pregnant patient;
- Poor compliance
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 |
|---|---|---|
| ESD procedureESD were all performed as the standard procedure that has been widely described and used. A diluted sodium hyaluronate solution was injected submucosally. Mucosal incision and submucosal dissection were performed by using either Hook knife (Olympus Medical, Japan) or a dual-knife (Olympus Medical, Japan) . After the resection was finished, all of the visible vessels on the artificial ulcer bed were thoroughly coagulated with argon plasma coagulation to prevent postoperative bleeding. | Procedure or surgery | ESD group |
| EMR-C procedureA transparent cap (MH-593; Olympus) was attached to the forward-viewing endoscope. After the endoscope was inserted to the rectum, the snare passed through the sheath and was looped along the inner lip of the cap. The tumor was then suctioned into the cap and the snare was pushed off and closed. After confirming the appropriate snare placement, both the tumor and the overlying mucosa were resected by electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and then the removed tumor was sent for pathological examination. Endoscopic examination then was repeated without the transparent cap in order to evaluate the wound carefully in case there was any perforation or bleeding and to ensure the absence of the residual tumor tissues. If there was spurting bleeding or active bleeding, hot forceps were usually to stop the bleeding. | Procedure or surgery | EMR-C group |
Primary outcome
complete resection rate(R0 rate)
Time frame: within 14 days after procedure
Complete resection was defined as negative horizontal and vertical margins of specimen.
5 secondary outcomes
operating time
Time frame: intraoperative
complications rate
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
recurrence rate
Time frame: one year after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 36455222Gao X, Huang S, Wang Y, Peng Q, Li W, Zou Y, Han Z, Cai J, Luo Y, Ye Y, Li A, Bai Y, Chen Y, Liu S, Li Y. Modified Cap-Assisted Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Rectal Neuroendocrine Tumors </=10 mm: A Randomized Noninferiority Trial. Am J Gastroenterol. 2022 Dec 1;117(12):1982-1989. doi: 10.14309/ajg.0000000000001914. Epub 2022 Aug 23.
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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. This study is not recruiting at the moment.
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 ESD procedure and EMR-C 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jun 2019. 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?
Results are not available in the source record.
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 rate(R0 rate) (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?
On the ClinicalTrials.gov record for NCT03982264, which also lists 1 linked publication.
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 11 Jun 2019.