An interventional study of TEAS + Urgent Endoscopy and Sham TEAS + Urgent Endoscopy in Gastrointestinal Endoscopy, Upper Gastrointestinal Hemorrhage and Variceal Bleeding, sponsored by Beijing 302 Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Beijing 302 Hospital · Not applicable, Interventional, and Supportive care
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:
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.
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.
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.
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:
4. Secondary Objectives:
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 180 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1. Inclusion Criteria:
2. Exclusion Criteria:
3. Dropout Criteria:
Participants receive active TEAS at bilateral Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Gongsun (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. All patients receive topical pharyngeal anesthesia and standard medical management.
Other: TEAS + Urgent Endoscopy
Participants receive sham TEAS with identical electrode placement at the same four acupoints using the same device, but no electrical current is delivered. The device appears active to maintain blinding. All patients receive topical pharyngeal anesthesia and standard medical management.
Other: Sham TEAS + Urgent Endoscopy
Participants receive standard urgent endoscopy care only, with no TEAS electrodes or device applied. They receive identical topical pharyngeal anesthesia and standard medical management as the other groups.
Other: Urgent Endoscopy Only
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.
Device: Hwato SDZ-III Electronic Acupuncture Treatment Instrument (no current) Identical electrode placement; no electrical stimulation; same duration as active group.
Standard urgent endoscopy with topical pharyngeal anesthesia; no TEAS intervention.
Procedural Success
A binary composite endpoint requiring both: 1. Technical adequacy: Complete visualization score of 4/4 for esophagus, stomach, duodenum to D2, and gastric fundus via retroflexion. 2. Patient satisfaction: Score ≤2 on a 5-point Likert scale (1=very acceptable to 5=very unacceptable).
Time frame: Immediately after the endoscopy procedure
Patient Discomfort
Mean score of five visual analogue scales (VAS, 0-10) assessing nausea/vomiting, throat discomfort, bucking, abdominal distension/pain, and agitation at 30 minutes post-procedure.
Time frame: At 30 minutes post-procedure
Procedural Efficiency - Diagnostic
Total endoscopy time (minutes) for diagnostic-only procedures, recorded from scope insertion to withdrawal.
Time frame: Immediately after the endoscopy procedure
Procedural Efficiency - Therapeutic
Total endoscopy time (minutes) for therapeutic interventions, recorded from scope insertion to withdrawal.
Time frame: Immediately after the endoscopy procedure
Immediate Hemostasis Success
Cessation of active bleeding observed at procedure completion (binary: yes/no). Assessed in the therapeutic subgroup.
Time frame: Immediately after the endoscopy procedure
7-Day Rebleeding Rate
Clinically significant bleeding from the same source within 7 days post-procedure, defined by recurrent hematemesis/melena with hemoglobin drop ≥2 g/dL or requiring repeat intervention. Assessed in the therapeutic subgroup.
Time frame: Within 7 days post-procedure
Heart Rate
Heart rate (beats per minute) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure.
Time frame: At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure
Systolic Blood Pressure
Systolic blood pressure (mmHg) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure.
Time frame: At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure
Respiratory Rate
Respiratory rate (breaths per minute) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure.
Time frame: At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure
Hemoglobin Change (Therapeutic Subgroup)
Change in hemoglobin concentration (g/dL) from pre-endoscopy to within 6 hours post-procedure.
Time frame: Pre-endoscopy to within 6 hours post-procedure
Willingness for Repeat Endoscopy
Patient-reported willingness to undergo the same procedure again if needed in the future (binary: yes/no), assessed at 15 minutes post-procedure.
Time frame: At 15 minutes post-procedure
Endoscopist-Rated Procedural Ease
Endoscopist assessment of procedural ease using a 5-point Likert scale (1=very easy to 5=very difficult).
Time frame: Immediately after the endoscopy procedure
Hospitalization Duration
Total length of hospital stay from admission to discharge (days).
Time frame: From admission to discharge, up to 30 days
Procedure-Related Complications
Incidence of procedure-related complications within 24 hours post-procedure.
Time frame: Within 24 hours post-procedure
Adverse Events
Incidence of adverse events related to TEAS or endoscopy, including skin erythema, dizziness, etc.
Time frame: From randomization to 7 days post-procedure
Blinding Assessment
Proportion of patients in active and sham TEAS groups correctly guessing their group assignment post-procedure.
Time frame: Immediately after the endoscopy procedure
Plan to share: No — 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. 2. 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.
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Beijing 302 Hospital