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A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection

A randomized controlled trial to assess the effectiveness of clip and snare method using pre-looping technique(CSM-PLT) for gastric endoscopic submucosal dissection - CSM-PLT trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027115
Enrollment
400
Registered
2017-07-01
Start date
2017-07-01
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 adenoma or early gastric cancer

Interventions

A: Conventional ESD group B: ESD using CSM-PLT group

Sponsors

Fukui prefectural hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically proven gastric adenoma or cancer 2. early gastric cancer which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline(ver4) 3. With only one lesion which will be treated endoscopically 4. Aged 20 years old or over 5. PS(ECOG)0.1.2 6. Meet all of the following criteria without blood transfusion in the past 14 days a.Hb >= 9g/dl b.Plt>= 100,000/mm3 c.AST,ALT <= 100 d.Cr <= 2.0mg/dl 7. Patients with written informed consent of this study

Exclusion criteria

Exclusion criteria: 1. Patient with registration history of this study 2. Patient who are pregnant, may be pregnant, or lactating woman 3. Patient with psychosis

Design outcomes

Primary

MeasureTime frame
ESD procedure time

Secondary

MeasureTime frame
ESD procedure time according to /1. the endoscopist experience(expert or non-expert) /2. the location of the lesion /3. size of the lesion /4. presence of ulceration /5. incision device 6. procedure time for submucosal dissection of the lesion 7. successful procedure rate of ESD non-expert 8. coagulation procedure, number of times, duration 9. en bloc resection rate 10. adverse events rate

Countries

Japan

Contacts

Public ContactNaohiro Yoshida, MD

Ishikawa Prefectural Central Hospital Department of Gastroenterology

ynaohiro@ipch.jp076-237-8211

Outcome results

None listed

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