Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Acute Pancreatitis

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Vagus Nerve Stimulations; Acute Pancreatitis (AP)

Treatments: Device: Sham-taVNS; Device: taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06998784

KY20242424

Details and patient eligibility

About

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 .

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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);
2. Implanted cardiac pacemaker or other electronic devices;
3. Prior treatment with transcutaneous auricular vagus nerve stimulation (taVNS);
4. Known malignancy;
5. Severe cardiovascular/cerebrovascular, hepatic, or renal diseases;
6. Cognitive impairment, psychiatric disorders, or other conditions that may affect patient cooperation;
7. Refusal to sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Treatment group

Experimental group

Description:

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

Treatment:

Device: taVNS

Sham-treatment group

Sham Comparator group

Description:

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

Treatment:

Device: Sham-taVNS