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Gastrointestinal EndoscopyTEAS-VBE-CNCT07106658

TEAS for Variceal Bleeding Endoscopy in Cirrhosis

A study testing TEAS + Urgent Endoscopy and Urgent Endoscopy Only in people with Gastrointestinal Endoscopy and Upper Gastrointestinal Hemorrhage, run by Beijing 302 Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
TEAS + Urgent Endoscopy and Urgent Endoscopy Only
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
18 Jul 2025to 12 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria:
  2. Patients aged 18-80 years with suspected or confirmed esophagogastric variceal bleeding
  3. Confirmed cirrhosis (any etiology/Child-Pugh class)
  4. Scheduled for urgent endoscopy as soon as possible following hemodynamic stabilization
  5. Ability to provide written informed consent (directly or through legally authorized representative)
  6. Exclusion Criteria:
  7. Hepatic encephalopathy ≥ Grade II
  8. Cognitive impairment or severe anxiety disorders preventing valid assessment
  9. Hemodynamic instability post-resuscitation (systolic BP <90 mmHg)
  10. Skin lesions at acupoint sites
  11. Presence of electrical implants (e.g., pacemakers)
  12. Allergies to TEAS electrodes or emergency medications
  13. Pregnancy or lactation
  14. History of long-term opioid use (>3 months)
  15. Inability to provide informed consent
  16. Prior TEAS or acupuncture experience (to maintain blinding integrity)
  17. Participation in another interventional trial within 30 days
  18. Dropout Criteria:
  19. Severe adverse events requiring immediate termination (anaphylaxis, hemodynamic collapse, oxygen desaturation <85%)
  20. Life-threatening complications during endoscopy (esophageal perforation, cardiac arrest)
  21. Inability to complete full esophagogastroduodenoscopy due to patient intolerance or technical failure
  22. Voluntary withdrawal by participant or legal representative

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100039

Other trials in China

About this study

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

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:

Read more
  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.

Read the 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).

  1. 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)
  3. Secondary Objectives:
  4. Shorten procedure time for diagnostic and therapeutic endoscopy
  5. Improve immediate hemostasis success and reduce 7-day rebleeding
  6. Enhance hemodynamic stability (heart rate, blood pressure, respiratory rate)
  7. Attenuate hemoglobin decline post-procedure
  8. Increase patient willingness for repeat endoscopy
  9. Improve endoscopist-rated procedural ease
  10. Shorten hospitalization duration
  11. 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.
  12. 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.
Being tested
TEAS + Urgent Endoscopy, Sham TEAS + Urgent Endoscopy, Urgent Endoscopy Only
Keywords
Variceal Bleeding, Transcutaneous Electrical Acupoint Stimulation, Cirrhotic, Procedural Tolerance
Medical subject headings
Gastrointestinal Hemorrhage, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEAS + Urgent EndoscopyOther

    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.

  • Sham TEAS + Urgent EndoscopyOther

    Device: Hwato SDZ-III Electronic Acupuncture Treatment Instrument (no current) Identical electrode placement; no electrical stimulation; same duration as active group.

  • Urgent Endoscopy OnlyOther

    Standard urgent endoscopy with topical pharyngeal anesthesia; no TEAS intervention.

Study groups in NCT07106658
Study groupRoleWhat they receive
Real TEAS + Urgent EndoscopyExperimentalParticipants 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.
Receives: Other: TEAS + Urgent Endoscopy
Sham TEAS + Urgent EndoscopySham comparatorParticipants 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.
Receives: Other: Sham TEAS + Urgent Endoscopy
Urgent Endoscopy OnlyOtherParticipants 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.
Receives: Other: Urgent Endoscopy Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Immediately after the endoscopy procedure

  2. 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.

    Measured: At 30 minutes post-procedure

Secondary outcomes (14)

  1. Procedural Efficiency - Diagnostic

    Total endoscopy time (minutes) for diagnostic-only procedures, recorded from scope insertion to withdrawal.

    Measured: Immediately after the endoscopy procedure

  2. Procedural Efficiency - Therapeutic

    Total endoscopy time (minutes) for therapeutic interventions, recorded from scope insertion to withdrawal.

    Measured: Immediately after the endoscopy procedure

  3. Immediate Hemostasis Success

    Cessation of active bleeding observed at procedure completion (binary: yes/no). Assessed in the therapeutic subgroup.

    Measured: Immediately after the endoscopy procedure

  4. 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.

    Measured: Within 7 days post-procedure

  5. Heart Rate

    Heart rate (beats per minute) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure.

    Measured: At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure

  6. Systolic Blood Pressure

    Systolic blood pressure (mmHg) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure.

    Measured: At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure

  7. Respiratory Rate

    Respiratory rate (breaths per minute) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure.

    Measured: At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure

  8. Hemoglobin Change (Therapeutic Subgroup)

    Change in hemoglobin concentration (g/dL) from pre-endoscopy to within 6 hours post-procedure.

    Measured: Pre-endoscopy to within 6 hours post-procedure

  9. 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.

    Measured: At 15 minutes post-procedure

  10. Endoscopist-Rated Procedural Ease

    Endoscopist assessment of procedural ease using a 5-point Likert scale (1=very easy to 5=very difficult).

    Measured: Immediately after the endoscopy procedure

  11. Hospitalization Duration

    Total length of hospital stay from admission to discharge (days).

    Measured: From admission to discharge, up to 30 days

  12. Procedure-Related Complications

    Incidence of procedure-related complications within 24 hours post-procedure.

    Measured: Within 24 hours post-procedure

  13. Adverse Events

    Incidence of adverse events related to TEAS or endoscopy, including skin erythema, dizziness, etc.

    Measured: From randomization to 7 days post-procedure

  14. Blinding Assessment

    Proportion of patients in active and sham TEAS groups correctly guessing their group assignment post-procedure.

    Measured: Immediately after the endoscopy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start18 Jul 2025
  3. Primary completion3 Feb 2026
  4. Study completion12 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07106658
Sponsor's protocol ID
2025-TEAS-Urgent Endoscopy
Acronym
TEAS-VBE-C
Status last verified
Apr 2026
First submitted
8 Jul 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 23888428

  • 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.

    PubMed 15557955

Questions about this trial

What is this clinical trial studying?

A study testing TEAS + Urgent Endoscopy and Urgent Endoscopy Only in people with Gastrointestinal Endoscopy and Upper Gastrointestinal Hemorrhage, run by Beijing 302 Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Success (time frame: Immediately after the endoscopy procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07106658, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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