Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 12:40 PM
Study NCT ID:
NCT07106658
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2025-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEAS in Liver Patients Needing Urgent Endoscopy for Bleeding Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The patient's discomfort level during urgent endoscopy for Esophagogastric variceal bleeding (EGVB)", 'timeFrame': 'At 30 minutes post-procedure', 'description': 'A self-made questionnaire comprising five visual analogue scales (VASs) evaluated discomfort across nausea and vomiting, throat discomfort, bucking, abdominal distension/pain, and agitation. Each VAS was a 10 cm horizontal line segment scored from 0 (no discomfort) to 10 (highest discomfort intensity), where patients marked their perceived level for each symptom. All participants completed the five VASs at 30 minutes post-procedure, and the mean score was calculated.'}], 'secondaryOutcomes': [{'measure': 'The degree of anxiety', 'timeFrame': 'Before urgent endoscopy and 30 minutes post-procedure', 'description': 'The degree of anxiety was evaluated using the Six-Item State-Trait Anxiety Inventory (STAI-S6), a validated short form derived from the Spielberger State-Trait Anxiety Inventory. This instrument comprises three items assessing state anxiety (transient emotional response) and three items assessing trait anxiety (stable anxiety proneness). Each item is scored on a 4-point Likert scale (1 = "Not at all" to 4 = "Very much"), yielding a total score range of 6 to 24 points, where higher scores indicate worse anxiety outcomes. Patients completed the STAI-S6 immediately before urgent endoscopy and 30 minutes post-procedure to quantify acute procedural distress and baseline anxiety characteristics.'}, {'measure': 'Blood pressure', 'timeFrame': 'At pre-endoscopy (baseline), during active endoscopy, and 30 minutes post-procedure', 'description': 'Blood pressure is measured in millimeters of mercury (mmHg). Systolic blood pressure and diastolic blood pressure were continuously monitored also using a multiparameter patient monitor (Type Prince-100B, Heal Force Bio-meditech Holdings Limited, China). Measurements were recorded at three phases: pre-endoscopy (baseline), during active endoscopy, and 30 minutes post-procedure to evaluate hemodynamic responses to the intervention.'}, {'measure': 'Heart rate', 'timeFrame': 'At pre-endoscopy (baseline), during active endoscopy, and 30 minutes post-procedure', 'description': 'Heart rate (unit of measure: beat per minute) was continuously monitored using a multiparameter patient monitor (Type Prince-100B, Heal Force Bio-meditech Holdings Limited, China). Measurements were recorded at three phases: pre-endoscopy (baseline), during active endoscopy, and 30 minutes post-procedure to evaluate hemodynamic responses to the intervention.'}, {'measure': 'Procedural Efficiency', 'timeFrame': 'Immediately after the endoscopy procedure', 'description': 'Endoscopy completion time (unit of measure: seconds) was electronically recorded from scope insertion to withdrawal. This metric was stratified by procedure complexity: Group 1 (diagnostic endoscopy only) versus Group 2 (therapeutic intervention for variceal bleeding), with comparative analysis across TEAS, sham, and control arms to assess workflow impact.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Variceal Bleeding', 'Transcutaneous Electrical Acupoint Stimulation', 'Cirrhotic'], 'conditions': ['Gastrointestinal Endoscopy', 'Upper Gastrointestinal Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '23888428', 'type': 'BACKGROUND', 'citation': 'Cheong YC, Dix S, Hung Yu Ng E, Ledger WL, Farquhar C. Acupuncture and assisted reproductive technology. Cochrane Database Syst Rev. 2013 Jul 26;2013(7):CD006920. doi: 10.1002/14651858.CD006920.pub3.'}, {'pmid': '15557955', 'type': 'BACKGROUND', 'citation': 'Lee H, Ernst E. Acupuncture for GI endoscopy: a systematic review. Gastrointest Endosc. 2004 Nov;60(5):784-9. doi: 10.1016/s0016-5107(04)02030-9. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a non-invasive electrical therapy (called TEAS) applied to specific points on the skin can help patients with severe liver disease better tolerate emergency stomach scope for serious bleeding. It will also test whether TEAS improves treatment success and recovery.\n\nThe main questions the study aims to answer are:\n\n1. Does TEAS make the emergency stomach scope procedure easier for patients with liver disease and serious bleeding to tolerate?\n2. Does TEAS help control bleeding better and lead to faster recovery?\n3. Is TEAS safe to use during this emergency procedure?\n\nResearchers will compare three approaches:\n\n1. Real TEAS: Electrical stimulation at specific points on hands/legs before/during the scope.\n2. Sham TEAS: Pads placed on the skin but no electrical stimulation.\n3. No TEAS: Standard procedure without any pads or stimulation.\n\nParticipants with acute upper digestive bleeding due to liver disease who need an emergency scope will:\n\n1. Be randomly assigned to one of the three groups.\n2. Receive either Real TEAS, Sham TEAS, or No TEAS just before and during their emergency stomach scope procedure.\n3. Have their comfort level during the scope measured (like pain, nausea).\n4. Have their vital signs (heart rate, blood pressure) monitored closely.\n5. Be checked for how well the bleeding was controlled, if bleeding happens again, need for blood transfusions, and time spent in the hospital.\n\nResearchers will watch for any side effects from the TEAS pads or the procedure.', 'detailedDescription': 'Background and Rationale:\n\nAcute esophagogastric variceal bleeding (AEGVB) in cirrhotic patients is a life-threatening emergency requiring urgent endoscopic intervention. Emergency endoscopy, often performed under conscious sedation or minimal anesthesia due to the urgency and patient instability, is associated with significant patient discomfort, poor tolerance, hemodynamic fluctuations (tachycardia, hypertension), nausea/vomiting, and compromised procedural success. This discomfort can lead to suboptimal visualization, incomplete treatment, and increased risk of complications. Effective, low-risk adjunctive methods to improve tolerance and stability during this critical procedure are needed. Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive modality derived from traditional acupuncture principles, delivering controlled electrical currents to specific acupoints via surface electrodes. Preliminary evidence suggests TEAS may reduce procedural discomfort, promote hemodynamic stability, regulate gastrointestinal function, and potentially enhance hemostasis. However, robust evidence on its efficacy and safety specifically during urgent endoscopy for AEGVB in cirrhotic patients is lacking. This trial aims to rigorously evaluate whether adjunctive TEAS improves procedural tolerance and clinical outcomes in this high-risk population.\n\nStudy Design and Methodology:\n\nThis is a prospective, randomized, single-center, three-arm, controlled trial. Cirrhotic patients presenting with AEGVB requiring urgent endoscopy within 48 hours will be assessed for eligibility. Eligible and consenting participants will be randomly assigned (1:1:1) using computer-generated random numbers with allocation concealment to one of three groups:\n\nActive TEAS Group: Receives real TEAS stimulation applied bilaterally to four predefined acupoints (Hegu \\[LI4\\], Neiguan \\[PC6\\], Zusanli \\[ST36\\], Gongsun \\[SP4\\]) using a standardized device (dense-disperse wave, 2/100Hz frequency, intensity adjusted to patient tolerance \\[typically 5-15mA\\]). Stimulation begins 10 minutes before endoscope insertion and continues throughout the endoscopic procedure.\n\nSham TEAS Group: Receives identical electrode placement at the same acupoints using the same device, but no electrical current is delivered (device appears active). This controls for the placebo effect of device application and acupressure.\n\nControl Group: Receives standard urgent endoscopy care without any TEAS electrodes or device application.\n\nAll participants receive standardized pre-endoscopic medical management (fluid resuscitation, vasoactive drugs, antibiotics as indicated) and undergo the urgent endoscopic procedure (diagnostic and therapeutic) performed by experienced endoscopists blinded to group assignment, using institutional protocols. The TEAS/sham operator is not involved in outcome assessment.\n\nPrimary Focus:\n\nThe study primarily investigates whether active TEAS, compared to sham or standard care:\n\nEnhances procedural tolerance: Measured objectively (hemodynamic stability - heart rate, blood pressure fluctuations during endoscopy) and subjectively (patient-reported discomfort using Visual Analogue Scale \\[VAS\\] during the procedure).\n\nImproves key clinical outcomes: Including initial hemostasis success rate, rates of very early (≤ 72h) and early (≤ 5d \\& ≤ 42d) rebleeding, transfusion requirements, and length of hospital stay.\n\nSafety Monitoring:\n\nAdverse events related to TEAS (e.g., local skin irritation, pain at electrode sites) and the endoscopic procedure (e.g., aspiration, perforation) are meticulously recorded and managed per protocol.\n\nScientific Justification:\n\nThe selection of specific acupoints (LI4, PC6, ST36, SP4) is based on traditional Chinese medicine principles and modern physiological understanding: targeting points associated with analgesia (LI4, PC6), gastrointestinal motility regulation and anti-emesis (PC6, ST36), hemodynamic stabilization (PC6), and potential enhancement of hemostatic mechanisms (SP4, ST36). The sham-controlled design is crucial for isolating the specific effects of electrical neuromodulation from non-specific placebo effects. This trial addresses a significant gap in optimizing the high-stakes scenario of urgent endoscopy for AEGVB by evaluating a readily deployable, non-pharmacological adjunctive strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1\\. Inclusion Criteria:\n\n1. Patients aged 18-80 years with suspected or confirmed esophageal-gastric variceal bleeding (EGVB);\n2. Patients with confirmed cirrhosis (any etiology/Child-Pugh class) presenting with upper gastrointestinal hemorrhage.\n\n2\\. Exclusion Criteria:\n\n1. Neuropsychiatric disorders preventing valid assessment:\n\n Hepatic encephalopathy ≥Grade II Severe anxiety Cognitive impairment\n2. High-risk physiological status:\n\n ASA class \\>III Hemodynamic instability (systolic BP \\<90 mm Hg after resuscitation)\n3. Contraindications for TEAS/emergency care:\n\n Skin lesions at acupoints Electrical implants Allergies to TEAS electrodes/emergency medications\n4. Pregnant or lactating women;\n5. History of long-term alcohol/opioid abuse;\n6. Inability to provide informed consent;\n7. Prior TEAS experience (to maintain blinding integrity).\n\n3\\. Dropout Criteria:\n\n1. Serious TEAS/endoscopy-related adverse reactions:\n\n Severe allergic reactions Hemodynamic collapse\n2. Life-threatening deterioration during endoscopy:\n\n Uncontrolled bleeding Respiratory failure Hepatic encephalopathy progression\n3. Principal investigator-identified safety risks (e.g., sepsis, acute liver failure);\n4. Inability to complete protocols due to emergent complications:\n\n Intubation Altered mental status ICU transfer\n5. Voluntary withdrawal by participant/legal representative.'}, 'identificationModule': {'nctId': 'NCT07106658', 'briefTitle': 'TEAS in Liver Patients Needing Urgent Endoscopy for Bleeding Veins', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'Transcutaneous Electrical Acupoint Stimulation (TEAS) in Cirrhotic Patients Undergoing Urgent Endoscopy for Acute Esophagogastric Variceal Bleeding: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '302-2025-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real TEAS + Urgent Endoscopy', 'description': 'Participants receive real Transcutaneous Electrical Acupoint Stimulation (TEAS) delivered via surface electrodes bilaterally at four predefined acupoints (Hegu \\[LI4\\], Neiguan \\[PC6\\], Zusanli \\[ST36\\], Gongsun \\[SP4\\]). Stimulation (dense-disperse wave, 2/100Hz frequency, intensity 5-15mA based on tolerance) begins 30 minutes before urgent endoscopy and continues throughout the procedure. All participants receive standard medical management and urgent endoscopy.', 'interventionNames': ['Other: TEAS + Urgent Endoscopy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TEAS + Urgent Endoscopy', 'description': 'Participants receive placebo TEAS. Electrodes are placed identically to the Active TEAS Group at the same four acupoints (Hegu \\[LI4\\], Neiguan \\[PC6\\], Zusanli \\[ST36\\], Gongsun \\[SP4\\]) using the same device, but no electrical current is delivered. The device appears active to maintain blinding. All participants receive standard medical management and urgent endoscopy.', 'interventionNames': ['Other: Sham TEAS + Urgent Endoscopy']}, {'type': 'OTHER', 'label': 'Urgent Endoscopy Only', 'description': 'Participants receive standard urgent endoscopy care only, with no TEAS electrodes or device applied. They receive identical standard medical management and urgent endoscopy as the other groups.', 'interventionNames': ['Other: Urgent Endoscopy Only']}], 'interventions': [{'name': 'TEAS + Urgent Endoscopy', 'type': 'OTHER', 'description': 'Participants receive real Transcutaneous Electrical Acupoint Stimulation (TEAS) delivered via surface electrodes bilaterally at four predefined acupoints (Hegu \\[LI4\\], Neiguan \\[PC6\\], Zusanli \\[ST36\\], Gongsun \\[SP4\\]). Stimulation (dense-disperse wave, 2/100Hz frequency, intensity 5-15mA based on tolerance) begins 30 minutes before urgent endoscopy and continues throughout the procedure. All participants receive standard medical management and urgent endoscopy.', 'armGroupLabels': ['Real TEAS + Urgent Endoscopy']}, {'name': 'Sham TEAS + Urgent Endoscopy', 'type': 'OTHER', 'description': 'Participants receive placebo TEAS. Electrodes are placed identically to the Active TEAS Group at the same four acupoints (Hegu \\[LI4\\], Neiguan \\[PC6\\], Zusanli \\[ST36\\], Gongsun \\[SP4\\]) using the same device, but no electrical current is delivered. The device appears active to maintain blinding. All participants receive standard medical management and urgent endoscopy.', 'armGroupLabels': ['Sham TEAS + Urgent Endoscopy']}, {'name': 'Urgent Endoscopy Only', 'type': 'OTHER', 'description': 'Participants receive standard urgent endoscopy care only, with no TEAS electrodes or device applied. They receive identical standard medical management and urgent endoscopy as the other groups.', 'armGroupLabels': ['Urgent Endoscopy Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Fifth Medical Center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zheng Lu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing 302 Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '1. Ongoing Research Commitments Further analyses and secondary studies using the same dataset are planned, including subgroup investigations and long-term outcome assessments. Premature data sharing could compromise the integrity of these planned works.\n2. Participant Privacy and Confidentiality The dataset contains sensitive clinical information (e.g., cirrhosis etiology, hemorrhage severity, neuropsychiatric status). Complete anonymization is challenging, and re-identification risks violate ethical/legal safeguards.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Gastroenterology and Hepatology', 'investigatorFullName': 'Liu Yan', 'investigatorAffiliation': 'Beijing 302 Hospital'}}}}