TEAS in Liver Patients Needing Urgent Endoscopy for Bleeding Veins

NCT ID: NCT07106658

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2025-07-15

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.

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.

Conditions

Gastrointestinal Endoscopy; Upper Gastrointestinal Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Real TEAS + Urgent Endoscopy

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.

Group Type: EXPERIMENTAL

TEAS + Urgent Endoscopy

Intervention Type: OTHER

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.

Sham TEAS + Urgent Endoscopy

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.

Group Type: SHAM_COMPARATOR

Sham TEAS + Urgent Endoscopy

Intervention Type: OTHER

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.

Urgent Endoscopy Only

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.

Group Type: OTHER

Urgent Endoscopy Only

Intervention Type: OTHER

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.

Interventions

TEAS + Urgent Endoscopy

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.

Intervention Type: OTHER

Sham TEAS + Urgent Endoscopy

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.

Intervention Type: OTHER

Urgent Endoscopy Only

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.

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Yan

Chief of Gastroenterology and Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zheng Lu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23888428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15557955 (View on PubMed)

Other Identifiers

302-2025-002

Identifier Type: -

Identifier Source: org_study_id