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临床试验/NCT06998784
NCT06998784已完成不适用

Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis: A Randomized Controlled Trial

Air Force Military Medical University, China5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
5
主要终点
Median treatment duration

研究概览

简要总结

Acute pancreatitis (AP), characterized by the sudden onset of pancreatic inflammation, is a frequent gastrointestinal emergency. Early suppression of the inflammatory response is critical to mitigate disease progression. When localized pancreatic inflammation progresses to systemic inflammation, triggering systemic inflammatory response syndrome (SIRS), the condition advances to moderate or severe AP, with mortality rates ranging from 10% to 40%. Additionally, early resumption of enteral nutrition reduces the risk of intra-abdominal infections and organ failure associated with AP. However, gastrointestinal dysfunction, which frequently manifests as gastroparesis or intestinal obstruction in severe cases , significantly complicates AP management by prolonging recovery time and compromising nutritional tolerance. Current early-phase management of AP remains suboptimal: anti-inflammatory strategies are predominantly limited to fluid resuscitation, while gastrointestinal function preservation is frequently underestimated. Consequently, effective therapies targeting both inflammatory suppression and gastrointestinal functional restoration in the early phase of AP are urgently needed.

The central nervous system plays a pivotal role in regulating peripheral immune responses, with the vagal anti-inflammatory signaling pathway serving as a key efferent pathway of the inflammatory reflex. Animal studies have shown a protective effect of the vagal anti-inflammatory signaling pathway against AP. Specifically, vagus nerve stimulation (VNS) significantly reduced pancreatic injury and improved survival in mice with severe AP. Furthermore, VNS has shown therapeutic potential in animal models of sepsis, shock, and renal ischemia-reperfusion injury, conditions frequently associated with systemic inflammation in severe pancreatitis. These findings suggest that VNS may alleviate both local and systemic inflammatory responses, as well as their complications.

Notably, prior clinical trial revealed that transcutaneous auricular VNS (taVNS) alleviated functional dyspepsia symptoms in adults, indicating its dual capacity for anti-inflammatory effects and gastrointestinal functional modulation. Based on this evidence, the investigators propose a randomized, sham-controlled trial to systematically evaluate the therapeutic efficacy of taVNS in patients with acute pancreatitis .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, 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

  • •AP patients aged 18-80 years.
  • •PAN-PROMISE score ≥15 and no participation in any other clinical trials within the past 3 months.

排除标准

  • •Presence of diseases or conditions different from AP that may interfere with the scale, for example, other causes of abdominal pain (especially acute cholecystitis), obstruction of the digestive tract (peptic pyloric stenosis, gastrointestinal anastomotic stenosis, diabetic gastroparesis, gastrointestinal neoplasia...), nausea-vomiting (brain tumour, chemotherapy...) or weakness (pre-existing anaemia with haemoglobin <9 g/dL, heart failure or respiratory insufficiency associated with minimal effort dyspnoea, or domiciliary treatment with O2, advanced neoplasms or other debilitating diseases);
  • •Implanted cardiac pacemaker or other electronic devices;
  • •Prior treatment with transcutaneous auricular vagus nerve stimulation (taVNS);
  • •Known malignancy;
  • •Severe cardiovascular/cerebrovascular, hepatic, or renal diseases;
  • •Cognitive impairment, psychiatric disorders, or other conditions that may affect patient cooperation;
  • •Refusal to sign informed consent.

研究组 & 干预措施

Treatment group

Experimental

Patients will receive taVNS at left tragus up to 7 days.

干预措施: taVNS (Device)

Sham-treatment group

Sham Comparator

Patients will receive sham-taVNS at left earlobe up to 7 days.

干预措施: Sham-taVNS (Device)

结局指标

主要结局

Median treatment duration

时间窗: Up to one week

The number of treatment days required to reduce the PAN-PROMISE scores to 6. The PAN-PROMISE score (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis from an international proSpEctive cohort study) consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. Each symptom is rated on a scale of 0 to 10 points, where higher scores reflect greater symptom severity.

次要结局

  • Biochemical Profiles(at treatment days 3)
  • PAN-PROMISE score during the study period(1 week)
  • Responder rate(1 week)
  • PAN-PROMISE score during the study period(1 week)
  • Responder rate(1 week)
  • Biochemical Profiles(at treatment days 3)
  • Median time from AP onset to enteral nutrition resumption(an average of 1 week)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Professor

Air Force Military Medical University, China

研究点 (5)

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