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The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m ) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m ). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Backgrounds Stent migration following endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) may sometimes be fatal because there are no adhesions between the biliary tract and stomach. To prevent stent migration and minimize the stent length in the abdominal cavity, we recently performed EUS-HGS using the technique of releasing the stent within the scope channel. Aims To examine the technical feasibility of the intra-scope channel stent release technique. Methods Forty-one consecutive patients who underwent EUS-HGS were enrolled. Between October 2015 and December 2015, EUS-HGS was performed using the extra-scope channel release technique, while the intra-scope channel release technique was performed between January 2016 and March 2016. Results The distance between the hepatic parenchyma and the stomach wall after EUS-HGS in the intra-scope channel stent release group was significantly shorter than that in the extra-scope channel release group (0.66 ± 1.25 vs 2.52 ± 0.97, P  < 0.05). Adverse events, such as biloma or stent migration, were seen in only the extra-scope channel release group. Conclusion In conclusion, although additional cases and randomized controlled studies using metal stents of various lengths are needed, our technique is likely to be clinically useful for the prevention of early and late stent migration.

Objectives A novel partially self‐expandable metal stent (PCSEMS) with an anti‐migration system has recently become available during Endoscopic ultrasound‐guided hepaticogastrostomy (EUS‐HGS) but requires tract dilation. No previous study has compared the performance of dilation devices during EUS‐HGS. The aim of this randomized controlled trial was to evaluate the technical success rate of tract dilation between a balloon catheter and drill dilator technique during EUS‐HGS prior to insertion of SEMS with an anti‐migration system. Methods A single‐center, randomized controlled trial comparing the balloon dilation and drill dilator techniques for first‐line tract dilation during EUS‐HGS. The primary outcome was the initial technical success rate of tract dilation for each technique during EUS‐HGS. The secondary outcome was adverse events associated with the procedures. Results Of 54 randomized patients who underwent EUS‐HGS at our center, there were 27 in the balloon dilation group and 27 in the drill dilation group. The initial technical success rate was 92.6% (25/27) in the balloon dilation group and 100% (27/27) in the drill dilation group (p = 0.1495). The technical success rate of stent delivery system insertion was significantly higher in the balloon dilation group (88%, 22/25) than in the drill dilation group (45%, 13/27; p = 0.0013). Procedure time was significantly shorter in the balloon dilation group (mean, 9.7 min) than in the drill dilation group (mean, 14.0 min; p = 0.047). Adverse events were more frequent in the drill dilation group (7.4% vs. 29.6%, p = 0.038). Conclusions Balloon dilation appears more suitable than drill dilation for PCSEMS with 8.5 Fr stent delivery system deployment. Clinical trial registration number University Hospital Medical Information Network 000049550.

Background: Weight loss remains significant in patients with head and neck cancer, despite prophylactic gastrostomy and intensive dietary counseling. The aim of this study was to improve outcomes utilising an early nutrition intervention. Methods: Patients with head and neck cancer at a tertiary hospital in Australia referred for prophylactic gastrostomy prior to curative intent treatment were eligible for this single centre randomised controlled trial. Exclusions included severe malnutrition or dysphagia. Patients were assigned following computer-generated randomisation sequence with allocation concealment to either intervention or standard care. The intervention group commenced supplementary tube feeding immediately following tube placement. Primary outcome measure was percentage weight loss at three months post treatment. Results: Recruitment completed June 2015 with 70 patients randomised to standard care (66 complete cases) and 61 to intervention (56 complete cases). Following intention-to-treat analysis, linear regression found no effect of the intervention on weight loss (10.9±6.6% standard care vs 10.8±5.6% intervention, P =0.930) and this remained non-significant on multivariable analysis ( P =0.624). No other differences were found for quality of life or clinical outcomes. No serious adverse events were reported. Conclusions: The early intervention did not improve outcomes, but poor adherence to nutrition recommendations impacted on potential outcomes.

Background Peristomal wound infection is a common complication in patients receiving percutaneous endoscopic gastrostomy (PEG). The main reason for peristomal infection might be the oral microbes coating the gastrostomy tube during implantation. Povidone-iodine solution can be applied for skin and oral decontamination. We designed a randomized controlled trial to test the effectiveness of a Betadine® (povidone-iodine) coated gastrostomy tube to reduce peristomal infection after percutaneous endoscopic gastrostomy. Methods A total of 50 patients were randomized to Betadine and control groups (25 patients in each group) from April 2014 to August 2021 at a tertiary medical center. All patients received the pull method for PEG implantation using a 24-french gastrostomy tube. The primary endpoint was peristomal wound infection rate 2 weeks after the procedure. Results Changes in Neutrophil/Lymphocyte ratio (N/L ratio) and C-Reative protein (Delta CRP) at 24 h after PEG were higher in the control group than in the Betadine group (N/L ratio, 3.1 vs. 1.2, p = 0.047; CRP, 2.68 vs.1.16, p = 0.009). The two groups did not differ in post-PEG fever, peristomal infection, pneumonia, or all-cause infection. Delta CRP could predict peristomal infection and all-cause infection within 2 weeks (AUROC 0.712 vs. 0.748; p  = 0.039 vs. 0.008). The best cut-off-point of Delta CRP for the diagnosis of peristomal wound infection was 3 mg/dl. Conclusion The betadine coating gastrostomy tube method could not reduce peristomal infection after percutaneous endoscopic gastrostomy. CRP elevation of less than 3 mg/dl may be used to exclude the potential peristomal wound infection. Trial registration NCT04249570 ( https://clinicaltrials.gov/ct2/show/NCT04249570 ).

BackgroundProximal gastrectomy (PG) has emerged as the preferred surgical approach for adenocarcinoma of the upper 1/3 stomach and selected cases of oesophagogastric junction adenocarcinoma. We developed a novel oesophagogastric anastomosis technique with an antireflux mechanism (Hao’s Esophagogastrostomy by Fissure Technique). It may have a superior effect on patient weight maintenance compared with the double-tract reconstruction. We intend to conduct a prospective, multicentre, randomised controlled clinical trial to validate this hypothesis.Methods and analysisThe primary objective evaluates body weight loss at 12 months postoperatively. Secondary objectives assess surgical safety through comprehensive analysis of complication rates and nutritional parameters, including serial haematological evaluations during follow-up. The study will enrol 52 participants across multiple centres with planned 3-year longitudinal monitoring to evaluate both immediate postoperative outcomes and intermediate-term clinical impacts.Ethics and disseminationThis study was approved by the hospital institutional review board of Huashan Hospital, Fudan University (2024-1173) and is being conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. On completion of the study, the results will be published in a peer-reviewed journal.Trial registration numberNCT06679244.

Background Percutaneous endoscopic gastrostomy (PEG) is often used to provide nutritional support in locally advanced head and neck cancer patients undergoing multimodality treatment. However, there is little published data on the impact of prophylactic versus reactive PEG. PEG placement may affect swallowing-related physiology, function, and quality of life. The Swall PEG study is a randomized controlled phase III trial testing the impact of prophylactic versus reactive PEG on patient-reported outcomes in terms of swallowing and quality of life in oropharyngeal cancer patients. Methods Patients with locally advanced oropharyngeal cancer receiving chemo-radiotherapy will be randomized to either the prophylactic or reactive PEG tube group. Randomization will be stratified by human papillomavirus (HPV) status and unilateral versus bilateral positive neck lymph nodes. The primary objective of the study is the patient’s reported outcome in terms of swallowing (MD Anderson Dysphagia Inventory (MDADI)) at 6 months. Secondary objectives include health-related quality of life, dosimetric parameters associated with patient-reported outcomes, chemo-radiation toxicities, PEG tube placement complications, the impact of nutritional status on survival and toxicity outcomes, loco-regional control, overall survival, the impact of HPV and tobacco smoking on survival outcomes and toxicities, and the cost-effectiveness of each treatment strategy. Discussion Findings from this study will enhance clinical evidence regarding nutritional management in oropharyngeal cancer patients treated by concurrent chemo-radiation. Trial registration ClinicalTrials.gov NCT04019548, study protocol version 2.0_08/08/2019. Registered on 15 July 2019

Background Nutritional management is important throughout the treatment period for esophageal cancer patients. This study aimed to evaluate the feasibility of percutaneous radiologic gastrostomy (PRG) and to investigate whether PRG can be applied for patients with advanced esophageal cancer. Methods In this study, 89 patients (74 men and 15 women) with advanced esophageal cancer underwent PRG using computed tomography and fluoroscopic guidance. These patients were unsuitable candidates for endoscopic intervention because of esophageal stricture. Primary placement of a mushroom-retained gastrostomy catheter was intended. The end points were technical success and complications after PRG as well as clinical outcomes and survival of the patients. These end points also were compared between the pre-chemoradiotherapy (pre-CRT) and post-CRT groups using the Chi square test, Fisher’s exact test, and the Wilcoxon rank sum test. The survival rate was calculated using the Kaplan–Meier method and compared using the log-rank test. Results All the patients had a successful PRG. The mushroom-tip gastrostomy catheter was primarily inserted in 77 patients (86.5 %) and finally achieved for all the patients. Complications occurred for 14 patients (15.7 %) including Dindo-Clavien classification grade 3 (1 catheter dislodgement), grade 2 (2 gastric hemorrhages), and grade 1 (7 skin infections and 4 oozing hemorrhages) complications. During the follow-up period (median, 6 months), 60 patients (67.4 %) died, giving a 12-month survival rate of 37.7 %. Gastrostomy removal was more common in the pre-CRT group ( P  = 0.011). The pre-CRT group had higher survival rates than the post-CRT group ( P  = 0.021). Conclusions Because PRG provided high technical success with limited complications, it can be used for patients with advanced esophageal cancer whose treatment plan involves multimodal therapy.

ObjectivesMalnutrition is associated with poor quality of life and survival outcomes for patients with cancer, but is challenging to prevent or treat in pancreatic cancer due to the multifactorial drivers of nutritional decline. A novel application of percutaneous endoscopic gastrostomy with a jejunal extension tube to deliver supplementary nutrition may improve outcomes, and will be tested in a randomised controlled trial. This study explored the perspectives of people living with pancreatic cancer regarding the acceptability of this proposed intensive nutrition intervention, to elucidate appropriateness and anticipated barriers, and facilitate informed design of the planned trial.MethodsParticipants were patients with pancreatic cancer previously enrolled in a Pancreaticobiliary Cancer Biobank. Qualitative semi-structured interviews were conducted by telephone and transcribed verbatim for deductive thematic analysis. The Framework Model was used, with the Theoretical Framework of Acceptability as the analytical framework.Results10 participants were recruited. Four overarching themes were developed from interviews: (1) deterioration in physical and mental well-being are consequences of debilitating nutrition impact symptoms; (2) willingness to participate depends on an individual threshold for nutritional deterioration; (3) predicted perceived effectiveness outweighed anticipated burdens and (4) adequate dietetic support is needed for maintaining a percutaneous endoscopic gastrostomy with jejunal extension feeding tube at home with confidence.ConclusionsMost participants believed that the intervention would benefit people with advanced pancreatic cancer to maintain their nutrition throughout chemotherapy. Regular and ad hoc support was considered essential, and the degree of individual nutritional deterioration was identified as an important indicator for trial participation.

Percutaneous endoscopic gastrostomy (PEG) is commonly chosen for long-term enteral nutrition support. However, common complications of PEG include wound infection, leakage, obstruction, bleeding, dislodgement, pneumonia, peritonitis, and more. The anticipation of these complications by both patients and their family caregivers underscores the essential requirement of ongoing technical guidance for the daily care of PEG and the adoption of preventative strategies. This study aimed to establish and compare a health education program utilizing a tracking system for PEG using a mobile app (PEG app) and instant messaging software versus a paper-based health education program with instant messaging software. Their effectiveness in preventing complications, avoiding hospital readmissions, improving self-care practices, and enhancing quality of life outcomes was assessed. A randomized controlled trial design was used, and the study sample consisted of patients from a medical center in central Taiwan who underwent thoracic surgery or gastroenterology procedures. Inclusion criteria were being a new case undergoing his or her first gastric tube insertion and having the ability to operate a smartphone. Exclusion criteria were cases requiring tube replacement or nasogastric tubes. A total of 74 participants were enrolled, with 37 participants in the experimental group and 37 participants in the control group. Data collection took place from hospitalization until 1 month after discharge. The experimental group received care using the gastric tube tracking system (PEG app) and the Line app that included phone, text, and photo capture capabilities, while the control group received routine nursing care and used the Line app. The experimental group demonstrated a significant reduction in the occurrence of complications compared with the control group (χ =12.087, P=.001). Specifically, the occurrence of leakage events was significantly lower in the experimental group than in the control group (χ =12.906, P=.001). However, the experimental group exhibited superior self-care ability compared with the control group (t =2.203, P=.03). There was no significant difference in overall quality of life scores between the experimental and control groups (t =1.603, P=.11). However, the experimental group showed better social aspects of quality of life than the control group (t =2.164, P=.03). Integration of the PEG app with instant messaging can enhance self-care ability, improve social aspects of quality of life, and reduce complications. The study results suggest that the PEG app could be used as an adjunct tool to promote patients' self-directed management of their gastric tube at home, particularly for patients who have undergone their first PEG placement and are being discharged from the hospital. Chinese Clinical Trial Registry ChiCTR2300071271; https://tinyurl.com/4vvy584e.