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A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models

A randomized controlled trial comparing conventional ESD versus ProKnife ESD with injective function for gastric lesions in porcine models - P-ESD trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044343
Enrollment
68
Registered
2021-05-28
Start date
2021-05-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Standard treatment group (Group A): conventional ESD Sstudy treatment group (Group B): ProKnife-ESD (P-ESD)

Sponsors

Kyushu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Pseudo-lesions created on resected porcine gastric ESD model (2) Tumor diameter of 30 mm or more

Exclusion criteria

Exclusion criteria: (1) Lesions spreading to the pylorus and fossa

Design outcomes

Primary

MeasureTime frame
ESD procedural time

Secondary

MeasureTime frame
Mucosal incision time and speed, submucosal dissection time and speed, en bloc resection rate, complete resection rate, amount of submucosal local injective solution, number of times local injection needles were used, whether the operator changed, whether traction was used, safety endpoint: rate of adverse events (intraoperative perforation)

Countries

Japan

Contacts

Public ContactMitsuru Esaki

Kyushu University Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences

esaki_saiseikai@yahoo.co.jp+81-92-642-5286

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026