Effects of nerve stimulation on recovery after pancreatic surgery
The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on the Incidence of Delayed Gastric Emptying After Pancreatoduodenectomy: A Randomized Controlled Trial
This study is testing if a special type of nerve stimulation can help patients recover better from pancreatic surgery by improving their stomach emptying.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06786923 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of transcutaneous auricular vagus nerve stimulation (taVNS) on patients undergoing pancreatoduodenectomy, specifically focusing on its effects on delayed gastric emptying. Patients are recruited one week prior to surgery and are randomly assigned to either a taVNS intervention group or a control group receiving sham stimulation. The taVNS intervention begins 30 minutes before anesthesia and continues until the end of surgery, with a double-blind design to ensure unbiased results. The study aims to understand the mechanisms behind any observed benefits of taVNS during the perioperative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with resectable pancreatic or periampullary tumors scheduled for pancreatoduodenectomy.
Not a fit: Patients with other malignant tumors, chronic organ dysfunction, or a history of gastrointestinal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of delayed gastric emptying in patients undergoing pancreatic surgery.
How similar studies have performed: While the use of taVNS is gaining interest, this specific application in the context of pancreatoduodenectomy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nantong, Jiangsu
- Affiliated hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Chao-Chao Zhong — Affiliated Hospital of Nantong University
- Study coordinator: Chao-Chao Zhong, M.D.;P.h.D
- Email: zhong249767626@163.com
- Phone: 15152460489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.