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A randomized controlled trial comparing conventional ESD versus Spray-ESD for gastric neoplasms: A multi-center trial (Spray-G Trial)

A randomized controlled trial comparing conventional ESD versus Spray-ESD for gastric neoplasms: A multi-center trial (Spray-G Trial) - Spray-G Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047353
Enrollment
130
Registered
2022-04-01
Start date
2022-04-04
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

Conventional ESD(ESD with Forced Coagulation Mode) Spray-ESD (ESD with Spray Coagulation Mode)

Sponsors

Kitakyushu Municipal Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Presence of EGN diagnosed by endoscopy and capable of undergoing ESD as a local treatment (2)Lesions diagnosed by endoscopic biopsy as gastric adenomas or adenocarcinomas (3)20 years old or more (4)Performance Status: 0, 1, 2 (5)Informed consent is obtained

Exclusion criteria

Exclusion criteria: (1)History of gastric surgery (2)Currently undergoing dialysis (3)Requiring continuous administration of heparin during the perioperative period. (4)Those with contraindications for endoscopy (5)Patients judged to be inappropriate for the study by the attending physician in this trial

Design outcomes

Primary

MeasureTime frame
Completion of ESD with endo-knife alone

Secondary

MeasureTime frame
Number of hemostasis, time of hemostasis, treatment time (total, mucosal incision, submucosal dissection), dissection speed, en bloc resection, complete resection, curative resection (degree of each endoscopic cure), thickness and thermal degeneration of submucosal layer in resected specimen, type and volume of submucosal injective solution used, operator change, traction use, complication

Countries

Japan

Contacts

Public ContactYorinobu Sumida

Kitakyushu Municipal Medical Center Department of Gastroenterology

y.raisin@gmail.com093-541-1831

Outcome results

None listed

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