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Completed

NCT Number: NCT06786923

The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy

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.

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Key information

Conditions

Delayed Gastric Emptying Digestive System Diseases Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulator

Device

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).

Primary outcomes

  1. Incidence of Postoperative Delayed Gastric Emptying

    Time frame: The first 7 days postoperatively

    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.

Secondary outcomes

  1. Incidence of Grade A, B, and C Postoperative Delayed Gastric Emptying

    Time frame: The first 21 days postoperatively

    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.

  2. Duration of Nasogastric Tube Drainage After Surgery

    Time frame: Up to 3 weeks postoperatively

    The time from the end of surgery to the first removal of the nasogastric tube

  3. Time to First Intake of Solid Food

    Time frame: Up to 3 weeks postoperatively

    The time to the first intake of solid food after surgery

  4. Incidence of Other Postoperative Complications Following Pancreatic Surgery (Including Pancreatic Fistula, Bile Leakage, Chylous Fistula, Postoperative Bleeding, and Abdominal Infection)

    Time frame: Up to 5 weeks postoperatively

    Incidence of other postoperative complications after pancreatic surgery (such as pancreatic fistula, bile leak, chyle leak, postoperative bleeding, and intra-abdominal infection)

  5. Severity of Postoperative Complications (Assessed Using the Clavien-Dindo Classification System)

    Time frame: Up to 5 weeks postoperatively

    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.

  6. Total Length of Hospital Stay

    Time frame: Up to 5 weeks postoperatively

    The total length of hospital stay refers to the entire duration of the patient's hospitalization from admission to discharge.

  7. NRS Score Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7

    Time frame: Preoperative Day 1, Postoperative Day 1, 3, 7

    The NRS (Numerical Rating Scale) is used to assess the intensity of pain.The higher the score, the more severe the pain.

  8. Hospital Anxiety and Depression Scale (HADS) Before Surgery and on Postoperative Days 7 and 14

    Time frame: Preoperative Day 1, Postoperative Day 7, 14

    The Hospital Anxiety and Depression Scale (HADS) is used to evaluate the severity of anxiety and depression in individuals.

  9. PROMIS SD-SF 8a Assessment on Preoperative and Postoperative Days 7 and 14

    Time frame: Preoperative Day 1, Postoperative Day 7, 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.

  10. Incidence of Postoperative Nausea and Vomiting (PONV) within 48 Hours

    Time frame: The first 48 hours postoperatively

    To determine the incidence of postoperative nausea and vomiting (PONV) within 48 hours.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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