Upper gastrointestinal perforation/bleeding
Conditions
Interventions
study group:Over-The-Scope Clip closure
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. age 18-70 years, male or female; 2. being able to understand the objective of the trial, willing to participate and sign the informed consent form voluntarily and complete follow-up as required in the protocol; 3. having at least one of the following clinical conditions and being scheduled for endoscopic soft tissue closure: a. Defect/perforation generated during endoscopic resection of upper gastrointestinal tumors or other lesions (e.g., EFTR/ESD/EMR, etc.), requiring use of metal clips to close the wound surface; b. Acute perforation of upper gastrointestinal tract, non-variceal bleeding or anastomotic leakage for various causes, schedued for endoscopic closure;
Exclusion criteria
Exclusion criteria: 1. Patients with variceal upper gastrointestinal bleeding; 2. Patients who are not suitable for Over-The-Scope Clip therapy due to anatomical factors, e.g., failure of the endoscope to reach the location or area of the lesion, the property not suitable for Over-The-Scope Clip closure; 3. Being unable to tolerate endoscopy or having contraindications for endoscopy, e.g., peritonitis or serious cardiac, pulmonary or cerebral insufficiency, multiple organ failure or sepsis; 4. Having a history of serious mental disorder or obvious consciousness disorder leading to failure of cooperation; 5. Having a previous history of serious coagulation disorder; 6. Having serious heart disease previously, e.g., myocardial infarction, unstable angina pectoris, heart failure (NYHA grade ? and ?) etc.; 7. Anesthesia ASA grade ? and above; 8. Combined with late malignant tumor, expected life span < 3 months; 9. Woman at childbearing age who is pregnant or breastfeeding; 10. Having participated in or ongoing participation in other drug or medical device clinica study in the past 3 months; 11. Other situations evaluated by investigators as unstable to be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate of closure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate of closure;Proportion of re-perforation/bleeding at the target lesion site;Success rate of removal of the Over-The-Scope Clip;Re-intervention rate of target lesion; | — |
Countries
China
Contacts
Public ContactZhou Pinghong
Zhongshan Hospital Fudan University
Outcome results
None listed