Clinical Research Directory

Gastric Focused Ultrasound Stimulation

This randomized, sham-controlled crossover pilot study will evaluate whether noninvasive gastric focused ultrasound stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adults with gastroparesis or delayed gastric emptying. Participants will complete one active FUS visit and one sham-stimulation visit in randomized order, separated by at least 48 hours. At each visit, electrogastrography will be recorded before and after a standardized liquid nutritional drink, during active or sham stimulation, and during recovery. Gastrointestinal symptoms will be assessed at prespecified time points using the Total Symptom Score questionnaire.

Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients

Pediatric trauma often leads to hemorrhagic shock, which reduces blood flow to the digestive tract and delays gastric emptying. This delay can cause fluid and food to remain in the stomach, increasing the risk of pulmonary aspiration during urgent airway management or emergency anesthesia. Point-of-care ultrasound (POCUS) is a bedside, non-invasive tool that allows clinicians to evaluate stomach contents and estimate gastric volume in real time. The primary purpose of this study is to evaluate whether restoring systemic blood flow through hemodynamic resuscitation improves gastric emptying and decreases gastric residual volume in injured children. Participants aged 2 to 7 years presenting to the emergency department with trauma and hemorrhagic shock will receive standard resuscitation according to pediatric advanced life support guidelines. Bedside gastric ultrasound will be performed to measure the antral cross-sectional area and calculate gastric residual volume before resuscitation begins, immediately following initial resuscitation, and every 6 hours for up to 48 hours. Ultrasound procedures are observational and will not delay any standard trauma care or urgent surgical interventions.

The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy

The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.

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.

Prevalence and Measurement of Delayed Gastric Emptying in Patients Receiving Extracorporeal Membrane Oxygenation

* The goal of this observational study is to learn whether the stomach takes longer to empty in patients on the intensive care unit who are receiving ECMO (a machine that temporarily takes over the role of the lungs and heart) compared to patients receiving support through a breathing machine (mechanical ventilation) only. It will also find the best way to measure stomach emptying at the bedside. * The main questions it aims to answer are: * What is the prevalence of slow stomach emptying and other stomach or bowel problems in patients receiving ECMO, compared to patients receiving mechanical ventilation but not receiving ECMO? (Stage A) * What is the best bedside method to measure stomach emptying in patients receiving ECMO? (Stage B) * Stage A of the study will involve measuring stomach emptying in study participants within four days of ICU admission, using two bedside methods: * 'Residual volumes' (removing liquid nutrition left in the stomach with a syringe, after this has been given through the participant's usual feeding tube) * A stomach ultrasound scan The researchers will check for differences between patients receiving ECMO versus no ECMO, and how this relates to the nutrition patients receive and how well or unwell they become in ICU. * In a smaller subgroup of patients receiving ECMO and participating in Stage B of the study, the researchers will also use scintigraphy. This is a standard research scan that tracks how the stomach empties by mixing a small, safe amount of radioactivity in the participant's usual liquid nutrition. The researchers will compare stomach emptying results from 'residual volumes' and stomach ultrasound with scintigraphy.

GLP-1 RA Cessation and Gastric Ultrasound Findings

This prospective observational study will evaluate the association between the time interval since the last dose of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and residual gastric contents before elective surgery. Adult patients receiving GLP-1 RAs and scheduled for elective non-cardiac surgery under general anesthesia will undergo preoperative point-of-care gastric ultrasound. The study will assess whether longer GLP-1 RA cessation intervals are associated with lower ultrasound-estimated gastric volume and a lower frequency of high-risk gastric contents. Body mass index will also be evaluated as a potential modifier of this association.

HbA1c Levels and Gastric Emptying Assessed by Gastric Ultrasound

Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control; however, its relationship with gastric emptying in surgical patients is not fully understood. This prospective observational study aims to evaluate the association between HbA1c levels and gastric emptying using preoperative bedside gastric ultrasonography. Adult patients scheduled for elective surgery under general anesthesia will undergo gastric ultrasound examination after standard fasting. Gastric antral cross-sectional area and estimated gastric volume will be assessed and compared according to HbA1c levels. The findings of this study may help improve preoperative risk stratification for aspiration and support individualized anesthetic management in patients with impaired glycemic control.

Gastric Assessment of Pediatric Patients Undergoing Surgery

The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are: * What is the reliability (inter-rater variability between expert and novice assessors, and intra-rater variability) of a) the gastric antral cross-sectional area (CSA) and b) gastric volume using the Perlas US qualitative grading assessment, measured by using an ultrasound device in pediatric patients undergoing general anesthesia for elective surgery? * What is the correlation between ultrasound assessment of gastric emptying by the antral-CSA and gastric emptying determined by the acetaminophen absorption test (AAT), the gold standard? The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects \>7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects \<7yrs of age and not expected to get an IV induction will be assigned to Cohort #2. * Cohort 1 will include abdominal ultrasound for gastric assessment AND the acetaminophen absorption test which includes administering enteral acetaminophen (tylenol) with 6 oz of water and drawing of blood samples through a peripheral intravenous line. * Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Procedures for Cohort 2 will include abdominal ultrasound only in the pre-op area (no tylenol). This cohort is included to examine the reliability of measurements across age groups.

Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD

Pylorus-preserving pancreatoduodenectomy (PPPD) is a standard surgical treatment for tumors of the pancreatic head and surrounding areas. However, it is frequently associated with delayed gastric emptying (DGE), a complication that can lead to nausea, vomiting, and prolonged hospital stays. This study is a randomized controlled trial designed to evaluate if a simple intraoperative maneuver (pneumatic balloon dilatation of the pylorus) can reduce the incidence of early postoperative vomiting and DGE. Participants will be randomly assigned to either the intervention group, receiving pyloric dilatation during surgery, or the control group, receiving standard surgery without dilatation. Researchers will monitor postoperative symptoms, gastric emptying function, and overall recovery to determine if this maneuver effectively improves patient outcomes.

Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes

The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery. This prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.

Intra-abdominal Hypertension and Abdominal Compartment Syndrome in Patients After Pancreatic Procedures.

This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.

GLP_1 RA Ultrasound Study

The purpose of the study is to determine whether patients taking GLP-1 RAs have increased residual (left behind), gastric (stomach), contents due to delayed gastric emptying when following standard preoperative fasting guidelines.

The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU). The goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks. A multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.