TEAS for Variceal Bleeding Endoscopy in Cirrhosis

NCT07106658 | Completed DMC

• 1 other identifier: 2025-TEAS-Urgent Endoscopy
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Sham TEAS: Identical electrode placement but no electrical current.
3. 3.Control: Standard endoscopy alone without electrodes.

Conditions

Gastrointestinal Endoscopy; Upper Gastrointestinal Hemorrhage; Variceal Bleeding; Cirrhosis

Keywords

Variceal Bleeding; Transcutaneous Electrical Acupoint Stimulation; Cirrhotic; Procedural Tolerance

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  At 30 minutes post-procedure

Secondary Outcomes (14)

• Procedural Efficiency - Diagnostic

  Immediately after the endoscopy procedure

• Procedural Efficiency - Therapeutic

  Immediately after the endoscopy procedure

• Immediate Hemostasis Success

  Immediately after the endoscopy procedure

• 7-Day Rebleeding Rate

  Within 7 days post-procedure

• Heart Rate

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

Study Arms (3)

Real TEAS + Urgent Endoscopy

EXPERIMENTAL

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

Sham TEAS + Urgent Endoscopy

SHAM COMPARATOR

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

Urgent Endoscopy Only

OTHER

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

Interventions

TEAS + Urgent Endoscopy OTHER

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.

Real TEAS + Urgent Endoscopy

Sham TEAS + Urgent Endoscopy OTHER

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

Sham TEAS + Urgent Endoscopy

Urgent Endoscopy Only OTHER

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

Urgent Endoscopy Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years with suspected or confirmed esophagogastric variceal bleeding
• Confirmed cirrhosis (any etiology/Child-Pugh class)
• Scheduled for urgent endoscopy as soon as possible following hemodynamic stabilization
• Ability to provide written informed consent (directly or through legally authorized representative)

You may not qualify if:

• Hepatic encephalopathy ≥ Grade II
• Cognitive impairment or severe anxiety disorders preventing valid assessment
• Hemodynamic instability post-resuscitation (systolic BP \<90 mmHg)
• Skin lesions at acupoint sites
• Presence of electrical implants (e.g., pacemakers)
• Allergies to TEAS electrodes or emergency medications
• Pregnancy or lactation
• History of long-term opioid use (\>3 months)
• Inability to provide informed consent
• Prior TEAS or acupuncture experience (to maintain blinding integrity)
• Participation in another interventional trial within 30 days
• \. Dropout Criteria:
• Severe adverse events requiring immediate termination (anaphylaxis, hemodynamic collapse, oxygen desaturation \<85%)
• Life-threatening complications during endoscopy (esophageal perforation, cardiac arrest)
• Inability to complete full esophagogastroduodenoscopy due to patient intolerance or technical failure

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (2)

• 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.

  PMID: 23888428 BACKGROUND

• 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.

  PMID: 15557955 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Fibrosis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zheng Lu, Doctor

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 6, 2025
• Study Start: July 18, 2025
• Primary Completion: February 3, 2026
• Study Completion: February 12, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)