Stomach Neuroendocrine NeoplasmPOEMNCT07728292
Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm
A study testing Endoscopic mucosal resection under water in people with Stomach Neuroendocrine Neoplasm, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Study objectives: Primary objective: 1.To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm. Secondary objectives: To evaluate: 1. En bloc resection rate 2. Immediate and delayed adverse events 3. Procedure time 4. Histologic quality of resection (deep and lateral margins) 5. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stomach Neuroendocrine Neoplasm
- What is being tested?
- Endoscopic mucosal resection under water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 17 Jul 2026to 30 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient-level
- Age ≥18 years
- Fit for endoscopic therapy and sedation
- Written informed consent
Who cannot join
- Lesion-level
- Endoscopically visible gastric neuroendocrine tumor
- Size 5-9 mm (endoscopic estimation)
- Clinical and/or histologic features consistent with type I gastric NET
- No endoscopic features suggestive of deep invasion
- Technically amenable to snare resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500082
Dr Mohan Ramchandani, MBBS MD DM, 04023378888 ext. 802, ramchandanimohan@gmail.com
Dr SHASHEENDRA YANAGANDULA, MBBS MS, 9676050769, shasheendra8@gmail.com
About this study
Official title: Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm: A Prospective Single-Centre Cohort Study
Study objectives:
Primary objective:
1.To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
Secondary objectives:
To evaluate:
- En bloc resection rate
- Immediate and delayed adverse events
- Procedure time
- Histologic quality of resection (deep and lateral margins)
- Residual disease at resection scar on surveillance endoscopy oMetachronous gastric NETs during follow-up
Read the detailed description
Study design This is a prospective, single-centre, single-arm cohort study evaluating UEMR for type I gastric NETs. Outcomes will be assessed at the lesion level, with statistical methods accounting for clustering of multiple lesions within individual patients.
Study population Inclusion criteria Patient-level
- Age ≥18 years
- Fit for endoscopic therapy and sedation
- Written informed consent Lesion-level
3.Endoscopically visible gastric neuroendocrine tumor 4.Size 5-9 mm (endoscopic estimation) 5.Clinical and/or histologic features consistent with type I gastric NET 6.No endoscopic features suggestive of deep invasion 7.Technically amenable to snare resection Exclusion criteria
Lesion-level
- Lesions <5 mm (managed with surveillance in routine practice)
- Lesions ≥10 mm
- Type II or type III gastric NET
- Evidence of muscularis propria invasion on EUS
- Distant metastasis or nodal disease on DOTANOC PET-CT
- Prior attempted resection at the same site with significant fibrosis
- Non-lifting lesion due to scarring
Patient-level
- Uncorrectable coagulopathy
- Inability to manage antithrombotic therapy as per guidelines
- Pregnancy
- Inability to provide informed consent
Pre-procedure evaluation
- Detailed clinical assessment and laboratory work-up as per institutional protocol
- Endoscopic documentation of:
- Lesion size, location, morphology
- Number of lesions
- Background mucosal atrophy
- EUS performed for lesions ≥8 mm, atypical morphology, or suspected deeper invasion
- DOTANOC PET-CT performed where clinically indicated to exclude metastatic disease
Intervention: Underwater EMR technique
- Standard diagnostic gastroscope
- Minimal insufflation followed by complete deflation of the gastric lumen
- Lumen filled with normal saline to achieve complete submersion of the lesion
- Optional marking for flat or ill-defined lesions
- Snare capture with a 1-2 mm margin under water
- Resection using standardized electrosurgical settings
- Defect management (clips or coagulation) at endoscopist discretion
- Retrieval of intact specimen
- Specimen orientation and pinning on cork for histopathologic assessment
Histopathologic assessment:
All specimens will be evaluated by experienced gastrointestinal pathologists.
Reported parameters:
- Tumor size
- Tumor grade and Ki-67 index
- Depth of invasion
- Lateral and vertical margins
- Lymphovascular invasion
- Resection status classified as:
- R0: negative lateral and vertical margins
- R1: microscopic margin positivity
- Rx: indeterminate margins
Outcome measures Primary outcome
- R0 resection rate per lesion Secondary outcomes
- En bloc resection rate
- Immediate bleeding (requiring endoscopic hemostasis)
- Delayed bleeding (within 14 days requiring medical attention)
- Perforation
- Procedure time (scope insertion to removal)
- Residual disease at scar on surveillance endoscopy (3-6 months)
- Metachronous lesions during follow-up
Follow-up protocol
- Clinical follow-up at 24-72 hours and at 14 days
- Surveillance endoscopy at 3-6 months post-resection
- Further surveillance as per institutional protocol for type I gastric NETs
- Conditions
- Stomach Neuroendocrine Neoplasm
- Being tested
- Endoscopic mucosal resection under water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic mucosal resection under waterProcedure or surgery
Also called EMRUW
- Standard diagnostic gastroscope
- Minimal insufflation followed by complete deflation of the gastric lumen
- Lumen filled with normal saline to achieve complete submersion of the lesion
- Optional marking for flat or ill-defined lesions
- Snare capture with a 1-2 mm margin under water
- Resection using standardized electrosurgical settings
- Defect management (clips or coagulation) at endoscopist discretion
- Retrieval of intact specimen
- Specimen orientation and pinning on cork for histopathologic assessment
| Study group | Role | What they receive |
|---|---|---|
| Type I Gastric Neuro Endocrine tumour | Other | Lesion should be less than 10mm size Receives: Procedure: Endoscopic mucosal resection under water |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
No recurrence after 3 months of procedure
Measured: 3 months
Secondary outcomes (3)
Immediate and delayed adverse events
To check any possible adverse events post procedure
Measured: 24 hours
Procedure time
To calculate the exact time of procedure
Measured: 30 minutes
Histologic quality of resection (deep and lateral margins)
To check the depth of invasion of the tumour
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start17 Jul 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Zaheer Dr Nabi, MD, Principal investigator, AIG HOSPITALSMohan Dr Ramchandani, MD, Study chair, AIG HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728292
- Sponsor's protocol ID
- EMR01
- Acronym
- POEM
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm: A Prospective Single-Centre Cohort Study
- ClinicalTrials.gov ID
- NCT07728292
- Acronym / sponsor ID
- POEM / EMR01
- Conditions
- Stomach Neuroendocrine Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Jul 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.
Study objectives:
Primary objective:
1.To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
Secondary objectives:
To evaluate:
- En bloc resection rate
- Immediate and delayed adverse events
- Procedure time
- Histologic quality of resection (deep and lateral margins)
- Residual disease at resection scar on surveillance endoscopy oMetachronous gastric NETs during follow-up
Detailed description
Study design This is a prospective, single-centre, single-arm cohort study evaluating UEMR for type I gastric NETs. Outcomes will be assessed at the lesion level, with statistical methods accounting for clustering of multiple lesions within individual patients.
Study population Inclusion criteria Patient-level
- Age ≥18 years
- Fit for endoscopic therapy and sedation
- Written informed consent Lesion-level
3.Endoscopically visible gastric neuroendocrine tumor 4.Size 5-9 mm (endoscopic estimation) 5.Clinical and/or histologic features consistent with type I gastric NET 6.No endoscopic features suggestive of deep invasion 7.Technically amenable to snare resection Exclusion criteria
Lesion-level
- Lesions <5 mm (managed with surveillance in routine practice)
- Lesions ≥10 mm
- Type II or type III gastric NET
- Evidence of muscularis propria invasion on EUS
- Distant metastasis or nodal disease on DOTANOC PET-CT
- Prior attempted resection at the same site with significant fibrosis
- Non-lifting lesion due to scarring
Patient-level
- Uncorrectable coagulopathy
- Inability to manage antithrombotic therapy as per guidelines
- Pregnancy
- Inability to provide informed consent
Pre-procedure evaluation
- Detailed clinical assessment and laboratory work-up as per institutional protocol
- Endoscopic documentation of:
- Lesion size, location, morphology
- Number of lesions
- Background mucosal atrophy
- EUS performed for lesions ≥8 mm, atypical morphology, or suspected deeper invasion
- DOTANOC PET-CT performed where clinically indicated to exclude metastatic disease
Intervention: Underwater EMR technique
- Standard diagnostic gastroscope
- Minimal insufflation followed by complete deflation of the gastric lumen
- Lumen filled with normal saline to achieve complete submersion of the lesion
- Optional marking for flat or ill-defined lesions
- Snare capture with a 1-2 mm margin under water
- Resection using standardized electrosurgical settings
- Defect management (clips or coagulation) at endoscopist discretion
- Retrieval of intact specimen
- Specimen orientation and pinning on cork for histopathologic assessment
Histopathologic assessment:
All specimens will be evaluated by experienced gastrointestinal pathologists.
Reported parameters:
- Tumor size
- Tumor grade and Ki-67 index
- Depth of invasion
- Lateral and vertical margins
- Lymphovascular invasion
- Resection status classified as:
- R0: negative lateral and vertical margins
- R1: microscopic margin positivity
- Rx: indeterminate margins
Outcome measures Primary outcome
- R0 resection rate per lesion Secondary outcomes
- En bloc resection rate
- Immediate bleeding (requiring endoscopic hemostasis)
- Delayed bleeding (within 14 days requiring medical attention)
- Perforation
- Procedure time (scope insertion to removal)
- Residual disease at scar on surveillance endoscopy (3-6 months)
- Metachronous lesions during follow-up
Follow-up protocol
- Clinical follow-up at 24-72 hours and at 14 days
- Surveillance endoscopy at 3-6 months post-resection
- Further surveillance as per institutional protocol for type I gastric NETs
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type I Gastric Neuro Endocrine tumour | Other | Procedure: Endoscopic mucosal resection under waterLesion should be less than 10mm size |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient-level
- Age ≥18 years
- Fit for endoscopic therapy and sedation
- Written informed consent
Key exclusion criteria (6 listed)
- Lesion-level
- Endoscopically visible gastric neuroendocrine tumor
- Size 5-9 mm (endoscopic estimation)
- Clinical and/or histologic features consistent with type I gastric NET
- No endoscopic features suggestive of deep invasion
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 mucosal resection under waterAlso: EMRUW* Standard diagnostic gastroscope * Minimal insufflation followed by complete deflation of the gastric lumen * Lumen filled with normal saline to achieve complete submersion of the lesion * Optional marking for flat or ill-defined lesions * Snare capture with a 1-2 mm margin under water * Resection using standardized electrosurgical settings * Defect management (clips or coagulation) at endoscopist discretion * Retrieval of intact specimen * Specimen orientation and pinning on cork for histopathologic assessment | Procedure or surgery | Type I Gastric Neuro Endocrine tumour |
Primary outcome
• To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
Time frame: 3 months
No recurrence after 3 months of procedure
3 secondary outcomes
Immediate and delayed adverse events
Time frame: 24 hours
Procedure time
Time frame: 30 minutes
Histologic quality of resection (deep and lateral margins)
Time frame: 5 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 27 Jul 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.
Zaheer Dr Nabi, MD principal investigator
AIG HOSPITALS
Mohan Dr Ramchandani, MD study chair
AIG HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic mucosal resection under water in people with Stomach Neuroendocrine Neoplasm, run by Asian Institute of Gastroenterology, India at 1 site in India.
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: looking for participants now, as of the sponsor's last update on 27 Jul 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 India. 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 Rajesh Mr Goud, M.Pharmacy (04023378888 ext. 103, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm. (time frame: 3 months). 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 27 Jul 2026.