The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy

The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on the Incidence of Delayed Gastric Emptying After Pancreatoduodenectomy: A Randomized Controlled Trial

To explore the effects of transcutaneous auricular vagus nerve stimulation (taVNS) during the perioperative period on the incidence of delayed gastric emptying after pancreatoduodenectomy and its possible mechanisms.

Study Overview

• Status: Completed
• Conditions: Delayed Gastric Emptying
• Intervention / Treatment: Device: Transcutaneous Auricular Vagus Nerve Stimulator

Detailed Description

Patients are recruited one week prior to the start of the trial, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants. Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham taVNS group) and the intervention group (taVNS group, with taVNS intervention starting 30 minutes prior to anesthesia induction and continuing until the end of surgery, terminating after the removal of the endotracheal tube in the PACU), in a double-blind manner (with taVNS intervention and postoperative follow-up conducted by different researchers).

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years;
• Diagnosed with pancreatic tumors or periampullary tumors by imaging or pathology and scheduled for pancreaticoduodenectomy;
• No distant metastases and tumors are resectable;
• Classified as American Society of Anesthesiologists (ASA) physical status I to III;
• Capable of understanding the study procedures and various assessment scales and able to effectively communicate with the researchers;
• Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

• Patients with other malignant tumors;
• Patients who have undergone chemotherapy or radiotherapy before surgery;
• Patients with chronic organ dysfunction;
• Patients with a history of gastrectomy or other gastric surgeries;
• Patients diagnosed with chronic gastrointestinal inflammation, peptic ulcers, or a history of gastroparesis, pyloric, or other gastrointestinal obstructions;
• Patients with a history of autonomic dysfunction (e.g., peripheral neuropathy, vagotomy, thyroid dysfunction, amyloidosis, asthma, heart failure, renal dysfunction, or alcoholism);
• Patients with implanted stimulators (e.g., pacemakers, implanted vagus nerve stimulators, deep brain stimulators, spinal cord stimulators), cochlear implants, or metallic implants (excluding dental work);
• Patients who recently used prokinetic agents, cholinergic or anticholinergic drugs, or hormones;
• Patients who received vagus nerve stimulation or acupuncture within 1 month before the study;
• Patients with skin damage or dermatological conditions at the stimulation site;
• Patients with a preoperative heart rate below 60 beats per minute;
• Patients unable to cooperate with assessments;
• Patients participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous auricular vagus nerve stimulation (taVNS group); Patients in the taVNS group will have a transcutaneous auricular vagus nerve stimulation device with a transparent, non-insulated thin film placed on the cymba conchae of the left ear. TaVNS will be administered on the day of surgery (starting 30 minutes before anesthesia induction and continuing until the end of the surgery, terminating after the removal of the endotracheal tube in the PACU). The stimulation parameters are set as follows: frequency 25 Hz, pulse width 200 μs, 30 seconds on / 30 seconds off, with the current intensity set to the maximum amplitude the patient can tolerate (just below the pain threshold).	Device: Transcutaneous Auricular Vagus Nerve Stimulator; Intervention Timing of Transcutaneous Auricular Vagus Nerve Stimulator: The intervention will begin 30 minutes before anesthesia induction and continue until the end of the surgery, terminating after the removal of the endotracheal tube in the PACU. The stimulation parameters are set as follows: frequency 25 Hz, pulse width 200 μs, 30 seconds on / 30 seconds off, with the current intensity set to the maximum amplitude the patient can tolerate (just below the pain threshold).
No Intervention: Sham transcutaneous auricular vagus nerve stimulation (Sham taVNS group); Patients in the Sham taVNS group will have a transcutaneous auricular vagus nerve stimulation device with a transparent insulating film placed on the cymba conchae of the left ear on the day of surgery. The stimulation parameters, method, and duration will be the same as those in the taVNS group. However, due to the insulating film applied to the stimulation device in the sham group, patients will not actually receive any stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Delayed Gastric Emptying	The definition of delayed gastric emptying (DGE) after pancreatic surgery, as suggested by the International Study Group of Pancreatic Surgery (ISGPS), is as follows: Excluding mechanical factors such as intestinal obstruction and anastomotic stricture, DGE can be diagnosed if any of the following conditions are met: The need for nasogastric tube placement persists for more than 3 days postoperatively.; Re-insertion of the nasogastric tube is required due to vomiting or other reasons after its removal.; The patient is unable to consume solid food 7 days postoperatively.	The first 7 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade A, B, and C Postoperative Delayed Gastric Emptying	Based on the severity of postoperative delayed gastric emptying (DGE) following pancreatic surgery, DGE is classified into three grades: A, B, and C: Grade A: Requires nasogastric tube placement from postoperative days 4 to 7 or re-insertion of the tube after 3 days. Patients are unable to tolerate oral solid food for more than 7 days postoperatively. Grade B: Requires nasogastric tube placement from postoperative days 8 to 14 or re-insertion of the tube after 7 days. Patients are unable to tolerate oral solid food for more than 14 days postoperatively. Grade C: Nasogastric tube cannot be removed within 14 days postoperatively or requires re-insertion after 14 days. Patients are unable to tolerate oral solid food for more than 21 days postoperatively.	The first 21 days postoperatively
Duration of Nasogastric Tube Drainage After Surgery	The time from the end of surgery to the first removal of the nasogastric tube	Up to 3 weeks postoperatively
Time to First Intake of Solid Food	The time to the first intake of solid food after surgery	Up to 3 weeks postoperatively
Incidence of Other Postoperative Complications Following Pancreatic Surgery (Including Pancreatic Fistula, Bile Leakage, Chylous Fistula, Postoperative Bleeding, and Abdominal Infection)	Incidence of other postoperative complications after pancreatic surgery (such as pancreatic fistula, bile leak, chyle leak, postoperative bleeding, and intra-abdominal infection)	Up to 5 weeks postoperatively
Severity of Postoperative Complications (Assessed Using the Clavien-Dindo Classification System)	The severity of postoperative complications (assessed using the Clavien-Dindo classification) refers to a system that classifies postoperative complications based on their severity. The Clavien-Dindo classification system is a widely used standardized method in clinical practice, designed to help doctors objectively assess the severity of postoperative complications, providing a basis for clinical management and research.The system classifies postoperative complications into five levels based on severity, ranging from Grade I (mildest) to Grade V (most severe). Each grade represents the impact of the complication on the patient and the degree of treatment required.	Up to 5 weeks postoperatively
Total Length of Hospital Stay	The total length of hospital stay refers to the entire duration of the patient's hospitalization from admission to discharge.	Up to 5 weeks postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV) within 48 Hours	To determine the incidence of postoperative nausea and vomiting (PONV) within 48 hours.	The first 48 hours postoperatively
NRS Score Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7	The NRS (Numerical Rating Scale) is used to assess the intensity of pain.The higher the score, the more severe the pain.	Preoperative Day 1, Postoperative Day 1, 3, 7
Hospital Anxiety and Depression Scale (HADS) Before Surgery and on Postoperative Days 7 and 14	The Hospital Anxiety and Depression Scale (HADS) is used to evaluate the severity of anxiety and depression in individuals.	Preoperative Day 1, Postoperative Day 7, 14
PROMIS SD-SF 8a Assessment on Preoperative and Postoperative Days 7 and 14	The Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8a (PROMIS SD-SF 8a) is an 8-item self-reported questionnaire developed by the Patient-Reported Outcomes Measurement Information System to assess sleep disturbance over the past 7 days. It evaluates aspects such as difficulty falling asleep, sleep maintenance, sleep quality, and daytime functioning, providing a standardized measure of sleep disturbance severity.	Preoperative Day 1, Postoperative Day 7, 14

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: Chao-Chao Zhong, Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroparesis
• Other Study ID Numbers: 2024-K265-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No