Transcutaneous Electrical Acupoint Stimulation for Suspected Variceal Bleeding Endoscopy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Procedural Success
研究概览
简要总结
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:
- 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.
- Sham TEAS: Identical electrode placement but no electrical current.
- 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.
详细描述
- 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.
- 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.
- Sham TEAS Group: Identical electrode placement but no electrical current; device appears active to maintain blinding.
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Inclusion Criteria:
- •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)
排除标准
- •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
- •3. 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
- •Voluntary withdrawal by participant or legal representative
研究组 & 干预措施
Sham 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.
干预措施: Sham TEAS + Urgent Endoscopy (Other)
Real TEAS + Urgent Endoscopy
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.
干预措施: TEAS + Urgent Endoscopy (Other)
Urgent Endoscopy Only
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.
干预措施: Urgent Endoscopy Only (Other)
结局指标
主要结局
Procedural Success
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Systolic Blood Pressure(At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure)
- Respiratory Rate(At pre-endoscopy (baseline), during endoscopy, and 30 minutes post-procedure)
- Hemoglobin Change (Therapeutic Subgroup)(Pre-endoscopy to within 6 hours post-procedure)
- Willingness for Repeat Endoscopy(At 15 minutes post-procedure)
- Endoscopist-Rated Procedural Ease(Immediately after the endoscopy procedure)
- Hospitalization Duration(From admission to discharge, up to 30 days)
- Procedure-Related Complications(Within 24 hours post-procedure)
- Adverse Events(From randomization to 7 days post-procedure)
- Blinding Assessment(Immediately after the endoscopy procedure)
研究者
Liu Yan
Chief of Gastroenterology and Hepatology
Beijing 302 Hospital