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:
Beijing 302 Hospital
Organization:
Study Overview
Official Title:
Transcutaneous Electrical Acupoint Stimulation (TEAS) in Cirrhotic Patients Undergoing Urgent Endoscopy for Acute Esophagogastric Variceal Bleeding: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
The main questions the study aims to answer are:
1. Does TEAS make the emergency stomach scope procedure easier for patients with liver disease and serious bleeding to tolerate?
2. Does TEAS help control bleeding better and lead to faster recovery?
3. Is TEAS safe to use during this emergency procedure?
Researchers will compare three approaches:
1. Real TEAS: Electrical stimulation at specific points on hands/legs before/during the scope.
2. Sham TEAS: Pads placed on the skin but no electrical stimulation.
3. No TEAS: Standard procedure without any pads or stimulation.
Participants with acute upper digestive bleeding due to liver disease who need an emergency scope will:
1. Be randomly assigned to one of the three groups.
2. Receive either Real TEAS, Sham TEAS, or No TEAS just before and during their emergency stomach scope procedure.
3. Have their comfort level during the scope measured (like pain, nausea).
4. Have their vital signs (heart rate, blood pressure) monitored closely.
5. Be checked for how well the bleeding was controlled, if bleeding happens again, need for blood transfusions, and time spent in the hospital.
Researchers will watch for any side effects from the TEAS pads or the procedure.
The main questions the study aims to answer are:
1. Does TEAS make the emergency stomach scope procedure easier for patients with liver disease and serious bleeding to tolerate?
2. Does TEAS help control bleeding better and lead to faster recovery?
3. Is TEAS safe to use during this emergency procedure?
Researchers will compare three approaches:
1. Real TEAS: Electrical stimulation at specific points on hands/legs before/during the scope.
2. Sham TEAS: Pads placed on the skin but no electrical stimulation.
3. No TEAS: Standard procedure without any pads or stimulation.
Participants with acute upper digestive bleeding due to liver disease who need an emergency scope will:
1. Be randomly assigned to one of the three groups.
2. Receive either Real TEAS, Sham TEAS, or No TEAS just before and during their emergency stomach scope procedure.
3. Have their comfort level during the scope measured (like pain, nausea).
4. Have their vital signs (heart rate, blood pressure) monitored closely.
5. Be checked for how well the bleeding was controlled, if bleeding happens again, need for blood transfusions, and time spent in the hospital.
Researchers will watch for any side effects from the TEAS pads or the procedure.
Detailed Description:
Background and Rationale:
Acute 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.
Study Design and Methodology:
This 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:
Active 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.
Sham 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.
Control Group: Receives standard urgent endoscopy care without any TEAS electrodes or device application.
All 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.
Primary Focus:
The study primarily investigates whether active TEAS, compared to sham or standard care:
Enhances 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).
Improves 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.
Safety Monitoring:
Adverse 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.
Scientific Justification:
The 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.
Acute 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.
Study Design and Methodology:
This 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:
Active 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.
Sham 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.
Control Group: Receives standard urgent endoscopy care without any TEAS electrodes or device application.
All 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.
Primary Focus:
The study primarily investigates whether active TEAS, compared to sham or standard care:
Enhances 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).
Improves 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.
Safety Monitoring:
Adverse 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.
Scientific Justification:
The 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: