Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT07106658
Eligibility Criteria:
1\. Inclusion Criteria:
1. Patients aged 18-80 years with suspected or confirmed esophageal-gastric variceal bleeding (EGVB);
2. Patients with confirmed cirrhosis (any etiology/Child-Pugh class) presenting with upper gastrointestinal hemorrhage.
2\. Exclusion Criteria:
1. Neuropsychiatric disorders preventing valid assessment:
Hepatic encephalopathy ≥Grade II Severe anxiety Cognitive impairment
2. High-risk physiological status:
ASA class \>III Hemodynamic instability (systolic BP \<90 mm Hg after resuscitation)
3. Contraindications for TEAS/emergency care:
Skin lesions at acupoints Electrical implants Allergies to TEAS electrodes/emergency medications
4. Pregnant or lactating women;
5. History of long-term alcohol/opioid abuse;
6. Inability to provide informed consent;
7. Prior TEAS experience (to maintain blinding integrity).
3\. Dropout Criteria:
1. Serious TEAS/endoscopy-related adverse reactions:
Severe allergic reactions Hemodynamic collapse
2. Life-threatening deterioration during endoscopy:
Uncontrolled bleeding Respiratory failure Hepatic encephalopathy progression
3. Principal investigator-identified safety risks (e.g., sepsis, acute liver failure);
4. Inability to complete protocols due to emergent complications:
Intubation Altered mental status ICU transfer
5. Voluntary withdrawal by participant/legal representative.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07106658
Study Brief:
Protocol Section:
NCT07106658