Cirrhosis, Gastrointestinal Endoscopy, Upper Gastrointestinal Hemorrhage, Variceal Bleeding
Conditions
Keywords
Variceal Bleeding, Transcutaneous Electrical Acupoint Stimulation, Cirrhotic, Procedural Tolerance
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. 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.
Interventions
OTHERTEAS + 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.
OTHERSham TEAS + Urgent Endoscopy
Device: Hwato SDZ-III Electronic Acupuncture Treatment Instrument (no current) Identical electrode placement; no electrical stimulation; same duration as active group.
OTHERUrgent Endoscopy Only
Standard urgent endoscopy with topical pharyngeal anesthesia; no TEAS intervention.
Sponsors
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. Inclusion Criteria: 1. Patients aged 18-80 years with suspected or confirmed esophagogastric variceal bleeding 2. Confirmed cirrhosis (any etiology/Child-Pugh class) 3. Scheduled for urgent endoscopy as soon as possible following hemodynamic stabilization 4. Ability to provide written informed consent (directly or through legally authorized representative) 2\.
Exclusion criteria
1. Hepatic encephalopathy ≥ Grade II 2. Cognitive impairment or severe anxiety disorders preventing valid assessment 3. Hemodynamic instability post-resuscitation (systolic BP \<90 mmHg) 4. Skin lesions at acupoint sites 5. Presence of electrical implants (e.g., pacemakers) 6. Allergies to TEAS electrodes or emergency medications 7. Pregnancy or lactation 8. History of long-term opioid use (\>3 months) 9. Inability to provide informed consent 10. Prior TEAS or acupuncture experience (to maintain blinding integrity) 11. Participation in another interventional trial within 30 days 3\. Dropout Criteria: 1. Severe adverse events requiring immediate termination (anaphylaxis, hemodynamic collapse, oxygen desaturation \<85%) 2. Life-threatening complications during endoscopy (esophageal perforation, cardiac arrest) 3. Inability to complete full esophagogastroduodenoscopy due to patient intolerance or technical failure 4. Voluntary withdrawal by participant or legal representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Immediately after the endoscopy procedure | 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). |
| Patient Discomfort | At 30 minutes post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Efficiency - Diagnostic | Immediately after the endoscopy procedure | Total endoscopy time (minutes) for diagnostic-only procedures, recorded from scope insertion to withdrawal. |
| Procedural Efficiency - Therapeutic | Immediately after the endoscopy procedure | Total endoscopy time (minutes) for therapeutic interventions, recorded from scope insertion to withdrawal. |
| Immediate Hemostasis Success | Immediately after the endoscopy procedure | Cessation of active bleeding observed at procedure completion (binary: yes/no). Assessed in the therapeutic subgroup. |
| 7-Day Rebleeding Rate | Within 7 days post-procedure | 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. |
| Heart Rate | At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure | Heart rate (beats per minute) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure. |
| Systolic Blood Pressure | At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure | Systolic blood pressure (mmHg) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure. |
| Respiratory Rate | At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure | Respiratory rate (breaths per minute) monitored at pre-endoscopy (baseline), during endoscopy (every 5 minutes), and 30 minutes post-procedure. |
| Hemoglobin Change (Therapeutic Subgroup) | Pre-endoscopy to within 6 hours post-procedure | Change in hemoglobin concentration (g/dL) from pre-endoscopy to within 6 hours post-procedure. |
| Willingness for Repeat Endoscopy | At 15 minutes post-procedure | Patient-reported willingness to undergo the same procedure again if needed in the future (binary: yes/no), assessed at 15 minutes post-procedure. |
| Endoscopist-Rated Procedural Ease | Immediately after the endoscopy procedure | Endoscopist assessment of procedural ease using a 5-point Likert scale (1=very easy to 5=very difficult). |
| Hospitalization Duration | From admission to discharge, up to 30 days | Total length of hospital stay from admission to discharge (days). |
| Procedure-Related Complications | Within 24 hours post-procedure | Incidence of procedure-related complications within 24 hours post-procedure. |
| Adverse Events | From randomization to 7 days post-procedure | Incidence of adverse events related to TEAS or endoscopy, including skin erythema, dizziness, etc. |
| Blinding Assessment | Immediately after the endoscopy procedure | Proportion of patients in active and sham TEAS groups correctly guessing their group assignment post-procedure. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZheng Lu, Doctor
Beijing 302 Hospital
Outcome results
None listed