The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy

NCT06786923 | Completed

• 1 other identifier: 2024-K265-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (1)

• 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: 1. The need for nasogastric tube placement persists for more than 3 days postoperatively. 2. Re-insertion of the nasogastric tube is required due to vomiting or other reasons after its removal. 3. The patient is unable to consume solid food 7 days postoperatively.

  The first 7 days postoperatively

Secondary Outcomes (10)

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

  The first 21 days postoperatively

• Duration of Nasogastric Tube Drainage After Surgery

  Up to 3 weeks postoperatively

• Time to First Intake of Solid Food

  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)

  Up to 5 weeks postoperatively

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

  Up to 5 weeks postoperatively

Study Arms (2)

Transcutaneous auricular vagus nerve stimulation (taVNS group)

EXPERIMENTAL

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

Sham transcutaneous auricular vagus nerve stimulation (Sham taVNS group)

NO INTERVENTION

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.

Interventions

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).

Transcutaneous auricular vagus nerve stimulation (taVNS group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chao-Chao Zhong

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: January 8, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)