New electrocoagulation system for preventing post-ESD Coagulation syndrome

Prospective study to analyze the efficacy of new electrocoagulation system (maXium) for preventing post-ESD Coagulation syndrome - NewPEC trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038049

Enrollment

110

Registered

2019-09-18

Start date

2019-09-23

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

colorectal adenoma, early colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Colorectal adenoma or eraly colorectal cancer =< 5cm that will be treated with ESD 2. Age from 20 to 85 years old 3. Agreement with signed informed consent

Exclusion criteria

Exclusion criteria: 1. Tumor size > 5cm 2. Cutting line will be into appendix, ileo-cecal valve or anus 3. Severe dysfunction of heart, lung and kidney 4. Poor status: Performance Status(ECOG) 3 or 4 5. VAS>20mm, BT>37.0(celsius) or WBC>normal range 6. Administration of steroid or pain killer 7. Administration of anti-cogulant drugs 8. Pregnancy 9. Inappropriateness with physician's judgement

Design outcomes

Primary

Measure	Time frame
Frequency of PECS	—

Secondary

Measure	Time frame
PECS frequency according to type and tumor location; The rate of delayed perforation, delayed bleeding and other complications; Treatment time of ESD; En bloc resection rate; Elucidation for clinical features of PECS	—

Countries

Japan

Contacts

Public ContactTakaya Shimura

Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology and Metabolism

tshimura@med.nagoya-cu.ac.jp052-853-8211

Outcome results