Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAsian Institute of Gastroenterology, India

About this trial

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. Residual disease at resection scar on surveillance endoscopy oMetachronous gastric NETs during follow-up

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Fit for endoscopic therapy and sedation

Written informed consent

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Endoscopic mucosal resection under water

    Procedure/Surgery

    * 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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Type I Gastric Neuro Endocrine tumourOther 1 intervention

Trial outcomes

Primary outcomes

1

• 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

Time frame
3 months

Secondary outcomes

1

Immediate and delayed adverse events

To check any possible adverse events post procedure

Time frame
24 hours
2

Procedure time

To calculate the exact time of procedure

Time frame
30 minutes
3

Histologic quality of resection (deep and lateral margins)

To check the depth of invasion of the tumour

Time frame
5 days

Other outcomes

Sponsors and contacts

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