Rectal Neuroendocrine TumorsNCT07612748
Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms
A study testing endoscopic intermuscular dissection (EID) and Endoscopic Submucosal Dissection (ESD) in people with Rectal Neuroendocrine Tumors and ESD, run by Jilin University at 2 sites in China.
Trial summary
The aim is to compare the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neuroendocrine Tumors, ESD, EPMR
- What is being tested?
- endoscopic intermuscular dissection (EID) and Endoscopic Submucosal Dissection (ESD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2026to 1 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing endoscopic treatment for rectal neuroendocrine neoplasms.
- Lesion diameter less than 2 cm.
- Preoperative auxiliary examinations indicating no peripheral lymph node or distant metastasis.
- Endoscopic surgical approach limited to ESD or EPMR.
Who cannot join
- Use of non-ESD or non-EPMR endoscopic techniques, such as ligation-assisted resection or Endoscopic Mucosal Resection (EMR).
- Presence of other conditions deemed by the investigator to be unsuitable for participation in this study.
- Patient or family refusal to participate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130021
Dong Yang, Doctor, 86-18844097668, yang_dong@jlu.edu.cn
- Active, not recruiting
the First Hospital of Jilin University
Changchun, 130021
About this study
Official title: Retrospective Comparative Study of Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms
The aim is to compare the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EPMR group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies.
Read the detailed description
The investigators compared the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EID group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies. Through this comparative analysis, The investigators would identify the optimal endoscopic technique for treating rectal neuroendocrine tumors.
- Conditions
- Rectal Neuroendocrine Tumors, ESD, EPMR
- Being tested
- endoscopic intermuscular dissection (EID), Endoscopic Submucosal Dissection (ESD)
- Keywords
- ESD, EPMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic intermuscular dissection (EID)Procedure or surgery
EID：Endoscopic Intermuscular Dissection (EID) is an ultra-minimally invasive technique derived from conventional Endoscopic Submucosal Dissection (ESD). Its core principle is not merely to dissect within the submucosal layer, but to "deepen" the dissection plane into the muscularis propria of the rectal wall. Specifically, the surgeon utilizes the natural anatomical plane between the inner circular muscle and the outer longitudinal muscle layers for precise dissection. This procedure involves resecting part of the affected inner circular muscle while preserving the integrity of the outer longitudinal muscle layer.
Endoscopic Submucosal Dissection (ESD)Procedure or surgery
ESD: A solution is injected beneath the mucosa to create a submucosal cushion, followed by the use of specialized electrosurgical knives to dissect directly within the submucosal layer, thereby achieving en bloc resection of the tumor.
| Study group | Role | What they receive |
|---|---|---|
| ESD group | Active comparator | The ESD group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic submucosal dissection (ESD). Receives: Procedure: Endoscopic Submucosal Dissection (ESD) |
| EID group | Experimental | The EPMR group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic partial muscle resection ( EPMR). Receives: Procedure: endoscopic intermuscular dissection (EID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the positive margin rate
A positive margin indicates that cancer cells extend to the edge of the removed specimen, suggesting that residual tumor may remain in situ. The positive margin rate is calculated as the number of cases with positive margins divided by the total number of resected cases, expressed as a percentage. It serves as a critical quality indicator for the completeness of tumor removal.
Measured: One week after the endoscopic treatment
Secondary outcomes (1)
Number of rectal neuroendocrine neoplasm lesions.
The number of rectal neuroendocrine neoplasm lesions per case.
Measured: One week after the endoscopic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal Neuroendocrine TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 483 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yang, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612748
- Sponsor's protocol ID
- 130023
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Cristofaro E, Rivory J, Masgnaux LJ, Wallenhorst T, Jacques J, Lafeuille P, Pioche M. Repeat endoscopic intermuscular dissection of the visible scar after noncurative endoscopic intermuscular dissection of a rectal neuroendocrine tumor. Endoscopy. 2024 Dec;56(S 01):E205-E206. doi: 10.1055/a-2261-7919. Epub 2024 Mar 1. No abstract available.
PubMed 38428913Liao S, Li B, Huang L, Qiu Q, Yang G, Ren J, Huang S. Endoscopic intermuscular dissection in the management of a rectal neuroendocrine tumor. Endoscopy. 2023 Dec;55(S 01):E977-E979. doi: 10.1055/a-2139-4310. Epub 2023 Aug 21. No abstract available.
PubMed 37604447
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparative Study of Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT07612748
- Acronym / sponsor ID
- 130023
- Conditions
- Rectal Neuroendocrine Tumors, ESD, EPMR
- Keywords
- ESD, EPMR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 483 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 May 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 is to compare the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EPMR group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies.
Detailed description
The investigators compared the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection（ EPMR） for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EID group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies. Through this comparative analysis, The investigators would identify the optimal endoscopic technique for treating rectal neuroendocrine tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD group | Active comparator | Procedure: Endoscopic Submucosal Dissection (ESD)The ESD group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic submucosal dissection (ESD). |
| EID group | Experimental | Procedure: endoscopic intermuscular dissection (EID)The EPMR group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic partial muscle resection ( EPMR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing endoscopic treatment for rectal neuroendocrine neoplasms.
- Lesion diameter less than 2 cm.
- Preoperative auxiliary examinations indicating no peripheral lymph node or distant metastasis.
- Endoscopic surgical approach limited to ESD or EPMR.
Key exclusion criteria (3 listed)
- Use of non-ESD or non-EPMR endoscopic techniques, such as ligation-assisted resection or Endoscopic Mucosal Resection (EMR).
- Presence of other conditions deemed by the investigator to be unsuitable for participation in this study.
- Patient or family refusal to participate.
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 |
|---|---|---|
| endoscopic intermuscular dissection (EID)EID：Endoscopic Intermuscular Dissection (EID) is an ultra-minimally invasive technique derived from conventional Endoscopic Submucosal Dissection (ESD). Its core principle is not merely to dissect within the submucosal layer, but to "deepen" the dissection plane into the muscularis propria of the rectal wall. Specifically, the surgeon utilizes the natural anatomical plane between the inner circular muscle and the outer longitudinal muscle layers for precise dissection. This procedure involves resecting part of the affected inner circular muscle while preserving the integrity of the outer longitudinal muscle layer. | Procedure or surgery | EID group |
| Endoscopic Submucosal Dissection (ESD)ESD: A solution is injected beneath the mucosa to create a submucosal cushion, followed by the use of specialized electrosurgical knives to dissect directly within the submucosal layer, thereby achieving en bloc resection of the tumor. | Procedure or surgery | ESD group |
Primary outcome
the positive margin rate
Time frame: One week after the endoscopic treatment
A positive margin indicates that cancer cells extend to the edge of the removed specimen, suggesting that residual tumor may remain in situ. The positive margin rate is calculated as the number of cases with positive margins divided by the total number of resected cases, expressed as a percentage. It serves as a critical quality indicator for the completeness of tumor removal.
1 secondary outcome
Number of rectal neuroendocrine neoplasm lesions.
Time frame: One week after the endoscopic treatment
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 3 Jun 2026.
- Results publication: PubMed 38428913De Cristofaro E, Rivory J, Masgnaux LJ, Wallenhorst T, Jacques J, Lafeuille P, Pioche M. Repeat endoscopic intermuscular dissection of the visible scar after noncurative endoscopic intermuscular dissection of a rectal neuroendocrine tumor. Endoscopy. 2024 Dec;56(S 01):E205-E206. doi: 10.1055/a-2261-7919. Epub 2024 Mar 1. No abstract available.
- Results publication: PubMed 37604447Liao S, Li B, Huang L, Qiu Q, Yang G, Ren J, Huang S. Endoscopic intermuscular dissection in the management of a rectal neuroendocrine tumor. Endoscopy. 2023 Dec;55(S 01):E977-E979. doi: 10.1055/a-2139-4310. Epub 2023 Aug 21. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic intermuscular dissection (EID) and Endoscopic Submucosal Dissection (ESD) in people with Rectal Neuroendocrine Tumors and ESD, run by Jilin University at 2 sites 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 3 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Dong Yang, Doctor (86-18844097668, yang_dong@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the positive margin rate (time frame: One week after the endoscopic treatment). 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 NCT07612748, which also lists 2 linked publications.
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 3 Jun 2026.