Clinical trial NCT06786923: The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy
Official title: The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on the Incidence of Delayed Gastric Emptying After Pancreatoduodenectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delayed Gastric Emptying
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Postoperative Delayed Gastric Emptying
timeFrame: The first 7 days postoperatively
Secondary outcomes:
measure: Incidence of Grade A, B, and C Postoperative Delayed Gastric Emptying
timeFrame: The first 21 days postoperatively
measure: Duration of Nasogastric Tube Drainage After Surgery
timeFrame: Up to 3 weeks postoperatively
measure: Time to First Intake of Solid Food
timeFrame: Up to 3 weeks postoperatively
measure: Incidence of Other Postoperative Complications Following Pancreatic Surgery (Including Pancreatic Fistula, Bile Leakage, Chylous Fistula, Postoperative Bleeding, and Abdominal Infection)
timeFrame: Up to 3 weeks postoperatively
measure: Severity of Postoperative Complications (Assessed Using the Clavien-Dindo Classification System)
timeFrame: Up to 3 weeks postoperatively
measure: Total Length of Hospital Stay
timeFrame: Up to 3 weeks postoperatively
measure: NRS Score Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7
timeFrame: From 1 day preoperatively to 7 days postoperatively
measure: Beck Anxiety Inventory (BAI) Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7
timeFrame: From 1 day preoperatively to 7 days postoperatively
measure: Beck Depression Inventory (BDI) Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7
timeFrame: From 1 day preoperatively to 7 days postoperatively
measure: Pittsburgh Sleep Quality Index (PSQI) Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7
timeFrame: From 1 day preoperatively to 7 days postoperatively
measure: Incidence of Postoperative Nausea and Vomiting (PONV) within 48 Hours
timeFrame: The first 48 hours postoperatively
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Chao-Chao Zhong
role: PRINCIPAL_INVESTIGATOR
References: