Colorectal Tumor
Conditions
Interventions
Post-colorectal ESD defects is approximated by the CLiPS technique, which involves pulling the mucosa together with a clip-line and securing with an endoloop.
Sponsors
NTT Medical Center Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Age over 20 years at registration. ECOG Performance Status of 0 or 1. Lesion size between 20-50 mm. The most recent blood test within 30 days prior to registration meets all of the following criteria (no blood transfusion within 14 days prior to the test used for registration) Hemoglobin over 9 g/dL Platelet count above 100,000 AST/ALT below 100 Serum creatinine below 2.0 mg/dL Able to be followed for 28 days after treatment. Written informed consent has been obtained.
Exclusion criteria
Exclusion criteria: Exclusion Criteria History of endoscopic treatment for lower gastrointestinal lesions within 28 days prior to enrollment. Planned endoscopic treatment for the lower gastrointestinal tract within 28 days after the procedure. Planned treatment of multiple lesions at the same time. Presence of active inflammatory bowel disease (ulcerative colitis or Crohn's disease). History of radiation therapy to the planned ESD area. Women who are possibly pregnant, currently pregnant, or breastfeeding. Presence of psychiatric conditions that impair understanding of the study. History of myocardial infarction or unstable angina within the past 3 months. Presence of a coagulation disorder (regardless of antithrombotic medication use). Active bacterial or fungal infection (defined as fever over 38.5 degrees with supporting radiologic or microbiological evidence). Presence of respiratory disease requiring continuous oxygen therapy. Uncontrolled hypertension. Any other condition deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Closure rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of the Closure Technique (Time required for defect closure,Types and number of devices used, Procedure-related adverse events) 2. Incidence of Post-closure Adverse Events (Delayed bleeding, Delayed perforation, Other complications) 3. Closure Integrity (Maintenance of defect closure at 2 days post-procedure) | — |
Countries
Japan
Contacts
Public ContactHiroshi Yamazaki
NTT Medical Center Tokyo Gastrointestinal Endoscopy
Outcome results
None listed