Percutaneous Endoscopic Gastrostomy: A Possible Trigger for Dieulafoy's Lesion.

Introduction: Upper gastrointestinal (GI) bleeding is a medical condition commonly seen in clinical practice due to variable etiologies and a multitude of presentations. The patients can present with hematemesis, melena, or hematochezia in case of severe bleeding. The initial evaluation should involve assessing the hemodynamic status with adequate resuscitation followed by diagnostic tests to identify the source and potentially treat it. Dieulafoy's lesion, sometimes referred to as Dieulafoy's disease, is a rare cause of upper GI bleeding with no clear risk factors, which makes it a diagnostic conundrum. Here we describe an unusual case of Dieulafoy's lesion developing following percutaneous endoscopic gastrostomy (PEG) placement. Case Presentation: We describe a case of a 70-year-old female patient with a past medical history of hyperlipidemia, well-controlled hypertension, and an ischemic cerebrovascular accident, which caused neurologic dysphagia and placement of a PEG tube 3 weeks prior. She presented to the emergency department due to melena, with hypotension of 90/50 mmHg, tachycardia of 126 beats/minute, and hemoglobin of 5.6 g/dl. An endoscopy revealed a Dieulafoy's lesion on the lesser curvature of the stomach just across the PEG tube, which was managed with epinephrine and hemoclips. Conclusion: This is a rare case of Dieulafoy's lesion on the lesser curvature of the stomach, potentially developing due to PEG placement.

Anesthesia experience in an adult Silver-Russell syndrome: a case report.

BACKGROUND: There are no reports of anesthesia use in adult patients with Silver-Russell syndrome (SRS). Here, we report our experience with anesthesia in an adult patient with SRS complicated by chronic respiratory failure. CASE PRESENTATION: A 33-year-old woman was clinically diagnosed with SRS. She had severe chronic respiratory failure, complicated by superior mesenteric artery syndrome. Percutaneous gastrostomy was scheduled for nutritional management under epidural anesthesia; however, soon after esophagogastroduodenoscopy was started, she lost consciousness and spontaneous respiration. The patient was urgently intubated and converted to general anesthesia. The end-tidal carbon dioxide tension was > 90 mmHg at intubation. CONCLUSIONS: Adult SRS patients with chronic respiratory failure have a risk of CO2 narcosis. SRS also requires preparation for difficult airway management during the perioperative period.

Evaluation of community nurse-led traumatic tube displacements.

Home enteral tube feeding (HEF) has many benefits and is largely safe practice. Some complications have historically required intervention in the acute setting, including traumatic displacement of feeding tubes (i.e. internal bumper/balloon removed intact), and evidence to support the safe replacement of these tubes in the community is lacking. To address this, a service enabling community homecare nurses (CHN) to replace traumatically displaced feeding tubes was designed and evaluated. Adult patients presenting with a traumatically displaced feeding tube over 29 months were included in the service evaluation. Baseline characteristics and outcomes at day 1, 7 and 6 months post-replacement were recorded. A total of 71 tube replacements were performed by CHNs in 60 patients. No clinical complications were recorded at any follow-up points. A simple cost analysis estimated savings of £235 754.40. These results suggest that nurse-led replacement of traumatically displaced feeding tubes in adults in the community is low-risk and offers potential cost savings.

No Impact of Enteral Nutrition on Fecal Short-Chain Fatty Acids in Children with Cerebral Palsy.

Bacteria can impact the host organism through their metabolites, with short-chain fatty acids (SCFAs) being the most important, including acetate (C2), propionate (C3), butyrate (C4), valerate (C5n), and isovalerate (C5i). This study aimed to identify the impact of enteral nutrition on SCFAs in children with cerebral palsy and to test the hypothesis that the type of nutrition in cerebral palsy affects gut SCFA levels. Cerebral palsy is a heterogeneous syndrome resulting from non-progressive damage to the central nervous system. The study group included 30 children diagnosed with cerebral palsy, receiving enteral nutrition (Cerebral Palsy Enteral Nutrition (CPEN)) via gastrostomy. The first reference group (Cerebral Palsy Controls (CPCs)) consisted of 24 children diagnosed with cerebral palsy and fed orally on a regular diet. The second reference group (Healthy Controls (HCs)) consisted of 24 healthy children with no chronic disease and fed on a regular diet. Isolation and measurement of SCFAs were conducted using gas chromatography. Differences were observed in the median contents of isobutyric acid, valeric acid, and isovaleric acid between the CPC group, which had significantly higher levels of those acids than the HC group. No differences were found between the CPEN and CPC groups nor between the CPEN and HC groups. We conclude that enteral nutrition in cerebral palsy has no influence on the levels of SCFAs.

Time trends and outcomes of gastrostomy placement in a Swedish national cohort over two decades.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) and laparoscopically inserted gastrostomy have become the gold standard for adult patients and children, respectively, requiring long-term enteral nutrition support. Procedure-related mortality is a rare event, often reported to be zero in smaller studies. National data on 30-d mortality and long-term survival rates after gastrostomy placement are scarce in the literature. AIM: To study the use of gastrostomies in Sweden from 1998-2019 and to analyze procedure-related mortality and short-term (< 30 d) and long-term survival. METHODS: In this retrospective, population-based cohort study, individuals that had received a gastrostomy between 1998-2019 in Sweden were included. Individuals were identified in the Swedish National Patient Register, and survival analysis was possible by cross-referencing the Swedish Death Register. The cohort was divided into three age groups: Children (0-18 years); adults (19-64 years); and elderly (≥ 65 years). Kaplan-Meier with log-rank test and Cox regression were used for survival analysis. RESULTS: In total 48682 individuals (52% males, average age 60.9 ± 25.3 years) were identified. The cohort consisted of 12.0% children, 29.5% adults, and 58.5% elderly. An increased use of gastrostomies was observed during the study period, from 13.7/100000 to 22.3/100000 individuals (P < 0.001). The use of PEG more than doubled (about 800 to 1800/year), with a corresponding decrease in open gastrostomy (about 700 to 340/year). Laparoscopic gastrostomy increased more than ten-fold (about 20 to 240/year). Overall, PEG, open gastrostomy, and laparoscopic gastrostomy constituted 70.0% (n = 34060), 23.3% (n = 11336), and 4.9% (n = 2404), respectively. Procedure-related mortality was 0.1% (n = 44) overall (PEG: 0.05%, open: 0.24%, laparoscopic: 0.04%). The overall 30-d mortality rate was 10.0% (PEG: 9.8%, open: 12.4%, laparoscopic: 1.7%) and decreased from 11.6% in 1998-2009 vs 8.5% in 2010-2019 (P < 0.001). One-year and ten-year survival rates for children, adults, and elderly were 93.7%, 67.5%, and 42.1% and 79.9%, 39.2%, and 6.8%, respectively. The most common causes of death were malignancies and cardiovascular and respiratory diseases. CONCLUSION: The annual use of gastrostomies in Sweden increased during the study period, with a shift towards more minimally invasive procedures. Although procedure-related death was rare, the overall 30-d mortality rate was high (10%). To overcome this, we believe that patient selection should be improved.

Factors Associated With Short-Term Complications After Percutaneous Endoscopic Gastrostomy Tube Insertion: A Retrospective Cohort Study.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) tube placement is generally safe but is associated with a range of complications. Minor complications include infections, granuloma formation, leakage, and blockages, while major complications encompass aspiration pneumonia, hemorrhage, and more serious conditions such as necrotizing fasciitis and colonic fistula. AIM: This study aimed to assess the rate of short-term complications within one month of endoscopic PEG insertion, focusing on their correlation with patient characteristics. METHODOLOGY: This retrospective cohort study analyzed data from patients who underwent PEG insertion between January 2020 and December 2022. It evaluated the incidence of complications in relation to variables such as the indication for the procedure, the patient's immune status, albumin and CRP levels, and the setting of the procedure (inpatient vs. outpatient). RESULTS: The study included 121 patients, with a mean age of 69.73 years, comprising 71 males (58.7%) and 50 females (41.3%). Neurological indications accounted for 64.5% of the cases. Notably, 67.8% of the patients were immunocompromised. Within 30 days of PEG insertion, 16.5% experienced complications, including GI bleeding (4.1%), infection at the PEG site (11.6%), and peritonitis (0.8%). Complications were significantly higher in immunocompromised patients and those with non-neurological indications. Higher serum albumin and lower CRP levels were associated with fewer complications, though the association was not statistically significant. CONCLUSION: The study highlights that gastrostomy site infection is the most common short-term complication following PEG insertion. Immune status and the reason for PEG insertion emerged as key factors influencing the likelihood of complications.

Endoscopic Complications Are More Frequent in Levodopa-Carbidopa Intestinal Gel Treatment via JET-PEG in Parkinson's Disease Patients Compared to Nutritional PEG in Non-Parkinson's Disease Patients.

Background: To date, no studies comparing complication rates between patients with nutritional percutaneous endoscopic gastrostomy (N-PEG) and Parkinson's disease (PD) patients with percutaneous endoscopic gastro-jejunostomy (JET-PEG) for treatment administration have been published. Our study aimed to compare complication rates and the number of re-endoscopies between N-PEG and JET-PEG patients. Methods: Individuals requiring N-PEG or JET-PEG insertion between 2014 and 2021 were included in this single-center retrospective observational study. Complications were divided into time-related medical and technical complications. Reasons for post-insertion re-endoscopies and their number were also analyzed. Results: Eighty-seven subjects, 47 (54.02%) in JET-PEG group and 40 (45.98%) in the N-PEG group, were included. Early and technical complications were more frequent in JET-PEG vs. N-PEG subjects (70% vs. 10% [p < 0.001], and 54.5% vs. 5.1% [p < 0.001], respectively). The presence of psychiatric disease was associated with a higher number of early complications (p < 0.002). All three types of complications were significantly more frequent in subjects where a healthcare professional did not handle PEG (p < 0.001). Subjects with JET-PEG required a higher number of re-endoscopies compared to the N-PEG group (57.1% vs. 35%, p = 0.05). Conclusions: Complications are significantly more common in individuals with JET-PEG than those with N-PEG, which can be attributed to higher mobility in PD patients.

Modifiable Preoperative Risk Factors to Mitigate Postoperative Site Infection Following Pediatric Gastrostomy.

PURPOSE: There are limited studies assessing modifiable preoperative risk factors for pediatric laparoscopic gastrostomy tubes (LGT) and percutaneous endoscopic gastrostomy (PEG) tubes. We sought to evaluate the effect of demographics and surgical/infectious history on the superficial infection rate following gastrostomy tube (GT) placement. METHODS: After IRB approval, we conducted a single-institution retrospective cohort study from 2015 to 2021 of pediatric patients undergoing LGT or PEG tube. The primary outcome was cellulitis or abscess formation within 30-days and 90-days postoperatively. Statistical analyses were performed with t-tests, Chi-squared, and logistic regression(p ≤ 0.05). RESULTS: There were 382 patients, with 181 (47%) LGT and 201 (53%) PEGs. LGT patients were younger (5.9 vs. 12.3 months, p < 0.001) and more likely to be admitted to the neonatal or cardiac intensive care unit prior to their GT. There were similar rates of prior surgical intervention (58% vs. 66%, p = 0.29) and previous infection (37% vs. 38%, p = 0.87) in both LGT and PEG patients. Within 30-days postoperatively, LGT patients had a higher superficial infection rate (12% vs. 6%, p = 0.04). On multivariate regression, Black race (Odds Ratio 0.10, p = 0.03) was protective and prior Staphylococcus colonization (OR 2.35, p = 0.04) increased the odds of infection. In those patients colonized with Staphylococcus, 21% developed a superficial site infection compared to 9% in those not colonized (p = 0.01). CONCLUSION: These data suggest prior Staphylococcus colonization is a significant risk factor for superficial infection following GT. Further work into preoperative decolonization strategies may provide an avenue to decrease the high infection rate in this common pediatric procedure. LEVEL OF EVIDENCE: Level III.

Retrograde Migration of a Percutaneous Endoscopic Gastro-Jejunal Tube Into the Esophagus.

Percutaneous endoscopic gastrostomy (PEG) and percutaneous endoscopic gastro-jejunal (PEG-J) tube placement are both common procedures regularly performed on patients requiring nutritional support. These procedures may be complicated by infection, hemorrhage, fistulization, or tube migration. We present an extremely rare case of a patient with a PEG-J tube that migrated into the esophagus.

Thoracic impedance pneumography in propofol-sedated patients undergoing percutaneous endoscopic gastrostomy (PEG) placement in gastrointestinal endoscopy: A prospective, randomized trial.

STUDY OBJECTIVE: To assess the efficacy of an ECG-based method called thoracic impedance pneumography to reduce hypoxic events in endoscopy. DESIGN: This was a single center, 1:1 randomized controlled trial. SETTING: The trial was conducted during the placement of percutaneous endoscopic gastrostomy (PEG). PATIENTS: 173 patients who underwent PEG placement were enrolled in the present trial. Indication was oncological in most patients (89%). 58% of patients were ASA class II and 42% of patients ASA class III. INTERVENTIONS: Patients were randomized in the standard monitoring group (SM) with pulse oximetry and automatic blood pressure measurement or in the intervention group with additional thoracic impedance pneumography (TIM). Sedation was performed with propofol by gastroenterologists or trained nurses. MEASUREMENTS: Hypoxic episodes defined as SpO2 < 90% for >15 s were the primary endpoint. Secondary endpoints were minimal SpO2, apnea >10s/>30s and incurred costs. MAIN RESULTS: Additional use of thoracic impedance pneumography reduced hypoxic episodes (TIM: 31% vs SM: 49%; p = 0.016; OR 0.47; NNT 5.6) and elevated minimal SpO2 per procedure (TIM: 90.0% ± 8.9; SM: 84.0% ± 17.6; p = 0.007) significantly. Apnea events >10s and > 30s were significantly more often detected in TIM (43%; 7%) compared to SM (1%; 0%; p < 0.001; p = 0.014) resulting in a time advantage of 17 s before the occurrence of hypoxic events. As a result, adjustments of oxygen flow were significantly more often necessary in SM than in TIM (p = 0.034) and assisted ventilation was less often needed in TIM (2%) compared with SM (9%; p = 0.053). Calculated costs for the additional use of thoracic impedance pneumography were 0.13$ (0.12 €/0.11 £) per procedure. CONCLUSIONS: Additional thoracic impedance pneumography reduced the quantity and extent of hypoxic events with less need of assisted ventilation. Supplemental costs per procedure were negligible. KEY WORDS: thoracic impedance pneumography, capnography, sedation, monitoring, gastrointestinal endoscopy, percutaneous endoscopic gastrostomy.

Comparison of anxiety and depression levels in caregivers of patients with percutaneous endoscopic gastrostomy for home enteral tube feeding against other enteral nutrition methods.

BACKGROUND: The aim of the study was to demonstrate whether the care burden of caregivers of bedridden patients, who experience feeding difficulties, decreases according to the Hospital Anxiety and Depression Scale (HADS) (1) after the patient has undergone PEG (Percutaneous Endoscopic Gastrostomy). The hypothesis of the study was that the levels of anxiety and depression of caregivers for patients fed via PEG decrease more than those for caregivers of patients fed through other enteral methods. Based on this, the goal is to recommend to palliative care and home care professionals the type of feeding method for bedridden patients that will create less burden on their relatives. METHODS: A comparison was made of the Hospital Anxiety and Depression Scale (HADS) scores among caregivers of patients receiving PEG and other enteral nutrition, focusing on changes between hospital admission and discharge. These changes were analyzed based on the caregiver's age, gender, and the duration of the patient's hospital stay. METHODS: This study conducted a comparative analysis of the Hospital Anxiety and Depression Scale (HADS) scores among caregivers of patients receiving Percutaneous Endoscopic Gastrostomy (PEG) versus other forms of enteral nutrition. The focus was on the variation in these scores from the time of the patients' hospital admission to their discharge. This analysis incorporated an examination of how these changes correlated with the caregiver's age and gender, as well as the duration of the patient's hospitalization. RESULTS: Despite longer hospital stays, a decrease in anxiety and depression was observed in caregivers of patients receiving PEG compared to the other group (p = 0.078). It was found that the decrease in anxiety and depression levels was less pronounced with increasing age of the caregiver (r=-0.202, p = 0.038). Hospital stay duration for patients receiving PEG was significantly longer than for those receiving other enteral nutrition methods (p = 0.017). CONCLUSIONS: We believe that Percutaneous Endoscopic Gastrostomy (PEG) should be the preferred method for long-term enteral nutrition due to its facilitation of effective and comfortable feeding and medication administration by caregivers. In palliative care services, for patients requiring long-term nutrition, PEG should be considered more prominently than other enteral feeding methods to reduce the anxiety of caregivers.

Percutaneous endoscopic gastrostomy in children receiving peritoneal dialysis: A tertiary centre long-term experience and literature review.

BACKGROUND: Children with severe chronic kidney disease receiving maintenance peritoneal dialysis (PD) are often malnourished and may require nutritional supplementation. Recent PD guidelines address laparoscopic and open surgical gastrostomy as safe approaches in children established on PD, while existing evidence on percutaneous endoscopic gastrostomy (PEG) is still lacking; as well as the role of perioperative antibiotic and antifungal prophylaxis. Hence, this study aimed to report our experience with PEG placement in patients on PD and compare it with the available literature. METHODS: We retrospectively reviewed the medical records from patients on PD, who underwent PEG placement at a tertiary referral centre between 2000 and 2020. Data on perioperative management, complications and outcomes were retrieved. An extensive literature search was performed; studies describing PEG placement and perioperative prophylaxis in patients on PD were used as a comparison. Descriptive statistical analysis was conducted. RESULTS: Seven patients (five males) were included. Perioperative antibiotic and antifungal prophylaxis were standard practice. At a median follow-up of 27 months (10-75), the peritonitis rate was 0.2 patient/years. No statistical significance was found between the peritonitis rate before and after PEG placement (p = 0.2). Patients' demographics and postoperative complications were comparable to the reported studies. CONCLUSIONS: Based on our experience, our technique of PEG insertion with antimicrobial prophylaxis is feasible and associated with an acceptable complication risk in patients on PD. Further multicentric studies about surgical technique in patients on PD will be necessary to verify the feasibility of PEG and standardise the perioperative protocol.

Immediate-use strategy is as safe and effective as delayed-use strategy following percutaneous endoscopic gastrostomy tube placement: A retrospective cohort study.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) tube placement is the most common enteral access for long-term feeding. The aim of our study is to assess the feasibility and safety of immediate PEG tube use after initial placement. METHODS: We conducted a single-center retrospective cohort study between August 2006 and August 2016. Prior to August 2011, tube feedings were delayed for ≥4 h after initial PEG placement, compared with immediate use (<1 h) after August 2011. Primary outcomes were complication rates within 30 days of placement. Secondary outcomes were impact of morbidity, mortality, length of stay, and need for repeat PEG placement. RESULTS: Our study included 1296 patients during the 10-year period, of which 704 underwent delayed use and 592 underwent immediate use (744 inpatient and 552 outpatient). There were no significant differences between the delayed-use and immediate-use PEG with regard to complications (3.4% vs 4.4%; P = 0.76). Subgroup analysis also reflected no significant differences in complications between inpatient and outpatient groups. For inpatients, there were no substantial differences in inpatient mortality (3.9% vs 3.3%; P = 0.70), mortality within 30 days of discharge (13.8% vs 13.1%; P = 0.15), readmissions (38.2% vs 34.3%; P = 0.23), repeat PEG placement (0.7% vs 1.5%; P = 0.46), and length of stay (13.3 vs 13.9 days; P = 0.99). CONCLUSION: Patients who received immediate enteral nutrition after PEG tube placement did not have any increased complications, morbidity, or mortality; and it is just as safe when compared with patients who received delayed feeding.

A Multicenter Survey of Percutaneous Endoscopic Gastrostomy in 2019 at Korean Medical Institutions.

Background/Aims: : This study aimed to review the indications, methods, cooperation, complications, and outcomes of percutaneous endoscopic gastrostomy (PEG). Methods: : Questionnaires were sent to 200 hospitals, of which 62 returned their questionnaires, with a response rate of approximately 30%. Descriptive statistics were calculated to analyze the responses to the questionnaires. Results: : In 2019, a total of 1,052 PEGs were performed in 1,017 patients at 62 hospitals. The main group who underwent PEG was older adult patients with brain disease, particularly stroke. Nutritional supply was an important purpose of the PEG procedure. "The pull method" was the most commonly used for initial PEG insertion. The complications related to PEG were mostly mild, with leakage being the most common. Patients who underwent PEG procedures were primarily educated regarding the post-procedure management and complications related to PEG. Preoperative meetings were skipped at >50% of the institutions. Regarding the cooperation between the nutrition support team (NST) and the physician performing PEG, few endoscopists answered that they cooperated with NST before and after PEG. Moreover, the rate of NST certification obtained by physicians performing PEG and the frequency of attendance at NST-related conferences were relatively low. Conclusions: : This study shows a similar trend to that found in the previous PEG guidelines. However, it covers new aspects, including team-based work for PEG procedure, nutrition support, and education for patients and guardians. Therefore, each medical institution needs to select an appropriate method considering the medical environment and doctor's abilities.

What to consider for successful administration of oral liquids via enteral feeding tubes? a case study with paediatric ibuprofen suspensions.

Administration of medications via enteral feeding tubes (EFTs) is a common practice for children who cannot swallow properly. Although liquid formulations are the preferred dosage forms for this route of administration, little attention has been paid to the amount of drug that reaches the site of absorption after administration via an EFT. This systematic in vitro study aimed to identify formulation parameters and administration approaches that are critical for successful dose delivery via EFTs. For this purpose, drug recovery after administration of three different paediatric ibuprofen suspensions via different types of EFTs was studied using derivative UV spectrophotometry for quantification. Study results indicate that in addition to formulation parameters, feeding tube characteristics and the administration process can have a significant impact on the administered dose. The ratio between the total administered fluid volume (TAV), represented by the sum of dose- and flushing volume, and the feeding tube volume (FTV) proved to be a valuable indicator for assessing successful administration. Incorrect dosing and complications could be avoided if the TAV/FTV ratio was greater than 4. This and other knowledge gained in the study will help to make the administration of liquid paediatric medicines via EFTs both more effective and safer.

Buried bumper syndrome in percutaneous endoscopic gastrostomy with a jejunal extension tube in patients undergoing levodopa-carbidopa intestinal gel treatment.

BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) treatment is an effective Parkinson's disease (PD) treatment that requires percutaneous endoscopic gastrostomy with a jejunal extension tube (PEG-J). Buried bumper syndrome (BBS) is an uncommon but significant complication of PEG-J for LCIG. Case presentation A 71-year-old man had been undergoing LCIG therapy for PD since a PEG-J was implemented at our department two years previously. He presented with appetite loss. Computed tomography showed that the gastrostomy bumper was buried in the gastric wall. The patient was surgically treated with the simultaneous removal and replacement of PEG-J. Postoperative gastrocutaneous fistula occurred, which was conservatively treated. CONCLUSIONS: Notably, patients and medical staff should be aware that patients with PD on LCIG treatment have a high risk of BBS in PEG-J and that there might be some patients with latent BBS. When simultaneous removal and replacement surgery is performed, establishing a new route at the stomach and abdominal wall is recommended.

Incidence of Pneumoperitoneum After Gastrostomy Tube Removal.

We present the case of an 88-year-old man with a previous medical history of severe colitis and colonic strictures who presented with hematemesis. The patient was found to have a lower esophageal ulcer without any signs of perforation. Esophagogastroduodenoscopy (EGD) revealed a scar in the greater curvature of the stomach from a previously removed gastrostomy tube two months prior. On CT imaging, an incidental finding of pneumoperitoneum was also found alongside stomach perforation near the healing scar. Due to the lack of evidence of any other colonic perforation, the patient was believed to have developed this pneumoperitoneum status post-gastrectomy tube removal two months prior to presentation. Pneumoperitoneum has a wide range of presenting symptoms that vary in severity and nature, and our patient failed to present with any physical or laboratory signs of infection. Over the course of the next four months, the patient was monitored with serial CT scans, during which the pneumoperitoneum resolved. In this report, we present a case of a patient who was found to develop pneumoperitoneum post-gastric tube removal and its complete resolution without surgical or procedural intervention.

Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis.

PURPOSE: Edaravone is a neuroprotective agent approved as an intravenous treatment for amyotrophic lateral sclerosis (ALS). The intravenous administration of edaravone places a burden on patients and there is a clinical need for oral agents for the treatment of ALS. This report aimed to assess the pharmacokinetics and safety of an edaravone oral suspension in patients with ALS after oral and percutaneous endoscopic gastrostomy (PEG) tube administration. METHODS: Two single-dose, open-label phase 1 clinical studies were conducted. Edaravone oral suspension (105 mg of edaravone in 5 mL aqueous suspension) was administered orally and via PEG tube to 9 and 6 Japanese patients with ALS, respectively. Plasma and urinary pharmacokinetics of unchanged edaravone and its metabolites (sulfate and glucuronide conjugates) were determined. Safety was also evaluated. FINDINGS: After reaching maximum plasma concentration, the mean plasma concentration-time of unchanged edaravone showed a triphasic elimination. Mean plasma concentration-time profiles of the metabolites were higher than those of unchanged edaravone. The mean urinary excretion ratios were higher for the glucuronide conjugate than for either unchanged edaravone or the sulfate conjugate. In patients administered edaravone orally, a single adverse event occurred (blood urine present), which was mild and improved without medical intervention. No adverse drug reactions or serious adverse events were reported. In patients administered edaravone via PEG tube, 5 treatment-emergent adverse events were reported in 3 patients; none were related to the study drug. No adverse drug reactions were reported. IMPLICATIONS: In patients with ALS, a single dose of edaravone oral suspension was well absorbed and mainly eliminated in urine as the glucuronide conjugate. No safety concerns emerged. Pharmacokinetics were similar to those previously reported in healthy participants following oral administration. This indicates that effective drug concentrations were achieved and edaravone can be successfully administered both orally and via a PEG tube in patients with ALS. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04176224 (oral administration) and NCT04254913 (PEG tube administration), www. CLINICALTRIALS: gov.

To push or to pull? A clinical audit on the efficacy and safety of the pull and push percutaneous endoscopic gastrostomy techniques in oncological patients.

BACKGROUND: The peroral "pull" technique and the direct "push" procedure are the two main methods for percutaneous endoscopic gastrostomy (PEG) placement. Although pull-PEG is generally recommended as the first-line modality, many oncological patients require a push-PEG approach to prevent tumor seeding or overcome tumor-related obstruction. OBJECTIVE: We aimed to compare the efficacy and safety of both PEG procedures in cancer patients. METHODS: We retrospectively analyzed all consecutive PEG procedures within a tertiary oncological center. Patients were followed up with the hospital databases and National Cancer Registry to assess the technical success rate for PEG placement, the rate of minor and major adverse events (AEs), and 30-day mortality rates. We compared those outcomes between the two PEG techniques. Finally, risk factors for PEG-related adverse events were analyzed using a multivariable Cox proportional-hazard regression model adjusted for patients' sex, age, performance status (ECOG), Body Mass Index (BMI), diabetes, chemoradiotherapy (CRT) status (pre-/current-/post-treatment), and type of PEG. RESULTS: We included 1055 PEG procedures (58.7% push-PEG/41.4% pull-PEG) performed in 994 patients between 2014 and 2021 (mean age 62.0 [±10.7] yrs.; 70.2% males; indication: head-and-neck cancer 75.9%/other cancer 24.1%). The overall technical success for PEG placement was 96.5%. Although the "push" technique had a higher rate of all AEs (21.4% vs. 7.1%, Hazard Ratio [HR]  = 2.9; 95% CI = 1.9-4.3, p < 0.001), most of these constituted minor AEs (71.9%), such as tube dislodgement. The methods had no significant difference regarding major AEs and 30-day mortality rates. Previous CRT was associated with an increased risk of major AEs (hazard ratio = 2.7, 95% CI = 1.0-7.2, p = 0.042). CONCLUSION: The risk of major AEs was comparable between the push- and pull-PEG techniques in cancer patients. Due to frequent tube dislodgement in push-PEG, the pull technique may be more suitable for long-term feeding. Previous CRT increases the risk of major AEs, favoring early ("prophylactic") PEG placement when such treatment is expected.