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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• AP patients aged 18-80 years.

• PAN-PROMISE score ≥15 and no participation in any other clinical trials within the past 3 months.

Locations
Other Locations
China
The 980th Hospital of the PLA Joint Logistics Support Force (Primary Bethune International Peace Hospital of PLA)
RECRUITING
Shijiazhuang
Department of Gastroenterology , Tangdu Hospital , Fourth Military Medical University
RECRUITING
Xi'an
Department of Gastroenterology, 986 Hospital of Xijing Hospital, Fourth Military Medical University
RECRUITING
Xi'an
Shaanxi Second People's Hospital
RECRUITING
Xi'an
Xijing Hospital of Digestive Diseases
RECRUITING
Xi'an
Contact Information
Primary
Yanglin Pan, M.D
yanglinpan@hotmail.com
13991811225
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-08-10
Participants
Target number of participants: 60
Treatments
Experimental: Treatment group
Patients will receive taVNS at left tragus up to 7 days.
Sham_comparator: Sham-treatment group
Patients will receive sham-taVNS at left earlobe up to 7 days.
Sponsors
Leads: Air Force Military Medical University, China

This content was sourced from clinicaltrials.gov