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A prospective comparative study on the effectiveness of SOUTEN knife and IT ESD knife in gastric endoscopic submucosal dissection for gastric tumor

A prospective comparative study on the effectiveness of SOUTEN knife and IT ESD knife in gastric endoscopic submucosal dissection for gastric tumor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005110
Enrollment
70
Registered
2020-06-11
Start date
2020-10-27
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

None listed

Interventions

Medical Device : This study compares the effectiveness of the group treated with the IT knife, which was widely used as an ESD knife, and the group treated with the SOUTEN knife when performing endosc

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 19 ~ 80 years old 2) One of the following - Low grade dysplasia proved on biopsy and the size is more than 1.5cm - High grade dysplasia proved on biopsy - Well to moderate differentiated early gastric cancer proved on biopsy and intramucosal cancer which size is less than 2cm without ulceration 3) No metastasis to another organ

Exclusion criteria

Exclusion criteria: 1) Serious systemic and coagulation disorder 2) History of previous endoscopic resection for gastric neoplasm 3) Pregnant or lactating patients 4) Antiplatelets taken within 5 days prior to surgery

Design outcomes

Primary

MeasureTime frame
Resection time

Secondary

MeasureTime frame
Total resection time;En bloc resection rate;Complete resection rate;Complications rate;Whether to use the rescue method

Countries

Korea, Republic of

Contacts

Public ContactDA HYUN JUNG

Yonsei University Health System, Severance Hospital

jungdh@yuhs.ac+82-2-2228-1934

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026