colorectal neoplasm
Conditions
Interventions
without clip closure after ESD
complete clip closure after ESD
Sponsors
Okayama University
Osaka Medical College Osaka Red Cross Hospital Takayama Red Cross Hospital University of Miyazaki Hospital Iwakuni Clinical Center Okayama Clinical Center Kurashiki Central Hospital Tsuyama Chuo Hospital Himeji Red Cross Hospital Hiroshima Citizens Hospital Fukuyama Medical Center Mitoyo General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.20mm-70mm colorectal lesions which will be treated by ESD 2.1 lesion per 1 patient 3.Adenoma or early cancer (pTis-pT1a) 4.Blood sample is within the specified values 5.Informed consent is obtained from the patient
Exclusion criteria
Exclusion criteria: 1.Lesions extending to the ileocecal valve, appendiceal orifice, lower rectum, or diverticulum 2.cT1b or more 3.Metal allergy 4.Heparin bridging is needed 5.PS 3 or 4 6.Steroids or immunomodulators usage 7.Pregnant or breastfeeding 8.Patients who have been judged as in appropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed adverse event rates (Post-ESD coagulation syndrome, delayed bleeding, delayed perforation), intention to treat analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Delayed adverse event rates, per protocol analysis Success rate of complete clip closure Duration of clip closure Number of clips Factors of incomplete closure Factors of delayed adverse events Hospital staying days | — |
Countries
Japan
Contacts
Public ContactYasushi Yamasaki
Okayama University Hospital Department of Gastroenterology
Outcome results
None listed