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Endoscopic non-coagulation Clipping method After gastric ESD for Prevention of delayed bleeding; Open label randomized controlled trial.(E-CAP trial)

Endoscopic non-coagulation Clipping method After gastric ESD for Prevention of delayed bleeding; Open label randomized controlled trial.(E-CAP trial) - E-CAP trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057963
Enrollment
350
Registered
2025-07-01
Start date
2025-11-17
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, Gastric adenoma

Interventions

Non-coagulation clipping is performed on the ulcer after ESD to prevent postoperative bleeding. Post-electrocoagulation syndrome is performed on the ulcer after ESD to prevent postoperative bleeding.

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor
Akasi city hospital, Omihachiman community medical center, Osaka Saiseikai suita hospital, MEDICAL CORPORATION KEISHINKAI Kyoto kidugawa hosipital, Japanese red cross Kyoto daiichi hospital, Saiseikai Shiga hospital, Otsu city hospital, Fukuchiyama city hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients have been diagnosed with gastric adenoma or early gastric cancer (including suspected cases) in preoperative examinations and are scheduled to undergo ESD. 2 Preoperative endoscopic examination reveals that the tumor is 5cm or less in long diameter. 3 Patients are aged older than 18 years and younger than 90 years at the time of enrollment. 4 Patients have been fully informed about participating in the study and have given their consent.

Exclusion criteria

Exclusion criteria: 1 Cases in which multiple lesions are scheduled to be treated on the same day 2 Cases in which the tumor length exceeds 5 cm 3 Cases in the postoperative stomach 4 Cases in which 14-day follow-up after ESD is not possible 5 Cases that the investigator deems inappropriate 6 Cases in which it is difficult to suspend antithrombotic drugs according to the guidelines 7 Cases in which patients undergoing hemodialysis 8 Cases in which patients with reduced renal function (Cre>2.0mg/mL) or reduced platelet count (PLT<5.0*10^7/mL) in preoperative blood sampling

Design outcomes

Primary

MeasureTime frame
Incidence of delayed bleeding within 14 days after ESD

Secondary

MeasureTime frame
Inflammatory findings in blood tests (WBC, CRP) the day after ESD Rate of occurrence of symptoms (fever and abdominal pain) related to post-electrocoagulation syndrome Time required for preventive treatment for bleeding Cost required for preventive treatment for bleeding Rate of occurrence of other adverse events including delayed perforation within 14 days after ESD Total length of hospital stay

Countries

Japan

Contacts

Public ContactOsamu Dohi

Kyoto Prefectural University of Medicine Molecular Gastroenterology and Hepatology, Graduate School of Medical Science

osamu-d@koto.kpu-m.ac.jp075-251-5111

Outcome results

None listed

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