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TEAS for Variceal Bleeding Endoscopy in Cirrhosis

NCT07106658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Beijing 302 Hospital

    lead OTHER

Principal Investigators

  • Zheng Lu, Doctor · Beijing 302 Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2026-02-03
Completion
2026-02-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106658 on ClinicalTrials.gov