NCT07106658

TEAS for Variceal Bleeding Endoscopy in Cirrhosis

Transcutaneous Electrical Acupoint Stimulation for Suspected Variceal Bleeding Endoscopy: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial evaluates whether transcutaneous electrical acupoint stimulation (TEAS) improves procedural success and patient tolerance in cirrhotic patients undergoing urgent unsedated endoscopy for suspected variceal bleeding. Participants with cirrhosis and suspected acute variceal bleeding requiring urgent endoscopy are randomly assigned to one of three groups: 1. Active TEAS: Electrical stimulation at bilateral Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Gongsun (SP4) starting 30 minutes before endoscopy and continuing until 15 minutes after the procedure. 2. Sham TEAS: Identical electrode placement but no electrical current. 3. Control: Standard endoscopy alone without electrodes. All patients receive topical pharyngeal anesthesia and standardized medical management. The study assesses procedural success (composite of technical adequacy and patient satisfaction), patient discomfort (visual analogue scale), procedure time, hemostasis outcomes, physiological parameters, and clinical experience measures.

Detailed description

1. Background and Rationale: Acute esophagogastric variceal bleeding (EGVB) in cirrhotic patients is a life-threatening emergency requiring urgent endoscopic intervention. Emergency endoscopy in unsedated patients is associated with significant discomfort, poor tolerance, hemodynamic fluctuations, and compromised procedural success. Safe, non-pharmacologic adjuncts to improve tolerance are needed. Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive modality that may reduce discomfort and stabilize physiological parameters. This trial evaluates whether TEAS improves procedural success and patient tolerance in this high-risk population. 2. Study Design and Methodology: This is a prospective, randomized, single-center, three-arm, parallel-group controlled trial. Cirrhotic patients with suspected variceal bleeding requiring urgent endoscopy are randomized 1:1:1 to active TEAS, sham TEAS, or control. Randomization is stratified by prior gastroscopy history with a block size of 6. Allocation is concealed using sequentially numbered, opaque, sealed envelopes. 1. Active TEAS Group: Receives TEAS at bilateral LI4, PC6, ST36, and SP4 using a Hwato SDZ-III stimulator (dense-disperse wave, 2/20 Hz, intensity set to maximum tolerance). Stimulation begins 30 minutes before endoscopy and continues until 15 minutes after the procedure. 2. Sham TEAS Group: Identical electrode placement but no electrical current; device appears active to maintain blinding. 3. Control Group: Standard endoscopy without electrodes. All patients receive topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) and standardized medical management including fluid resuscitation, vasoactive drugs, and antibiotics as indicated. Endoscopic procedures are performed by experienced endoscopists blinded to group assignment using Olympus GIF-Q260J endoscopes. Variceal bleeding is managed per standard of care (band ligation, sclerotherapy, or tissue glue injection). 3\. Primary Focus: The study primarily investigates whether active TEAS, compared to sham or standard care: 1. Improves procedural success (composite of technical adequacy and patient satisfaction) 2. Reduces patient discomfort (assessed by visual analogue scale) 4\. Secondary Objectives: 1. Shorten procedure time for diagnostic and therapeutic endoscopy 2. Improve immediate hemostasis success and reduce 7-day rebleeding 3. Enhance hemodynamic stability (heart rate, blood pressure, respiratory rate) 4. Attenuate hemoglobin decline post-procedure 5. Increase patient willingness for repeat endoscopy 6. Improve endoscopist-rated procedural ease 7. Shorten hospitalization duration 5\. Safety Monitoring: Adverse events related to TEAS (e.g., local skin irritation, pain at electrode sites) and the endoscopic procedure are recorded and managed per protocol. 6\. Scientific Justification: The selected acupoints (LI4, PC6, ST36, SP4) have established roles in analgesia, gastrointestinal motility regulation, anti-emesis, and hemodynamic stabilization. The sham-controlled design isolates specific effects of electrical neuromodulation from placebo. This trial addresses a significant gap in optimizing urgent endoscopy for variceal bleeding using a non-pharmacologic adjunct.

Conditions

• Gastrointestinal Endoscopy
• Upper Gastrointestinal Hemorrhage
• Variceal Bleeding
• Cirrhosis

Interventions

Type	Name	Description
OTHER	TEAS + Urgent Endoscopy	Device: Hwato SDZ-III Electronic Acupuncture Treatment Instrument Stimulation at LI4, PC6, ST36, SP4; 2/20 Hz dense-disperse wave; intensity to maximum tolerance; 30 min pre-procedure to 15 min post-procedure.
OTHER	Sham TEAS + Urgent Endoscopy	Device: Hwato SDZ-III Electronic Acupuncture Treatment Instrument (no current) Identical electrode placement; no electrical stimulation; same duration as active group.
OTHER	Urgent Endoscopy Only	Standard urgent endoscopy with topical pharyngeal anesthesia; no TEAS intervention.

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-02-03
• Completion: 2026-02-12
• First posted: 2025-08-06
• Last updated: 2026-04-13

Locations

1 site across 1 country: China