Delayed Gastric EmptyingNCT06786923
The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy
A study testing Transcutaneous Auricular Vagus Nerve Stimulator in people with Delayed Gastric Emptying, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Gastric Emptying
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Delayed Gastric Emptying
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulator
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulatorDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first 7 days postoperatively
Secondary outcomes (10)
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.
Measured: 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
Measured: Up to 3 weeks postoperatively
Time to First Intake of Solid Food
The time to the first intake of solid food after surgery
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Up to 5 weeks 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.
Measured: 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.
Measured: 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.
Measured: Preoperative Day 1, Postoperative Day 7, 14
Incidence of Postoperative Nausea and Vomiting (PONV) within 48 Hours
To determine the incidence of postoperative nausea and vomiting (PONV) within 48 hours.
Measured: The first 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start17 Jan 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaochao Zhong, Affiliated Hospital of Nantong University
- Investigators
- Chao-Chao Zhong, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786923
- Sponsor's protocol ID
- 2024-K265-02
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on the Incidence of Delayed Gastric Emptying After Pancreatoduodenectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06786923
- Acronym / sponsor ID
- 2024-K265-02
- Conditions
- Delayed Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (taVNS group) | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulatorPatients 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulatorIntervention 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). | Device | Transcutaneous auricular vagus nerve stimulation (taVNS group) |
Primary outcome
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: 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.
10 secondary outcomes
Incidence of Grade A, B, and C Postoperative Delayed Gastric Emptying
Time frame: The first 21 days postoperatively
Duration of Nasogastric Tube Drainage After Surgery
Time frame: Up to 3 weeks postoperatively
Time to First Intake of Solid Food
Time frame: 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)
Time frame: Up to 5 weeks postoperatively
Severity of Postoperative Complications (Assessed Using the Clavien-Dindo Classification System)
Time frame: Up to 5 weeks postoperatively
Total Length of Hospital Stay
Time frame: Up to 5 weeks postoperatively
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
Hospital Anxiety and Depression Scale (HADS) Before Surgery and on Postoperative Days 7 and 14
Time frame: Preoperative Day 1, Postoperative Day 7, 14
PROMIS SD-SF 8a Assessment on Preoperative and Postoperative Days 7 and 14
Time frame: Preoperative Day 1, Postoperative Day 7, 14
Incidence of Postoperative Nausea and Vomiting (PONV) within 48 Hours
Time frame: The first 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Chao Zhong principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulator in people with Delayed Gastric Emptying, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delayed Gastric Emptying (time frame: The first 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.