Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial.

BACKGROUND AND AIMS: Adequate bowel preparation is crucial for clear mucosal visualization during colonoscopy. We aimed to comprehensively compare oral sulfate solution (OSS) and 3-L split-dose polyethylene glycol (PEG) for bowel preparation before colonoscopy. METHODS: This randomized, active-controlled, noninferiority study was performed in 10 medical centers. Eligible subjects were enrolled to receive OSS or 3-L PEG in a split-dose regimen. The quality of bowel preparation, adverse reactions, and acceptability were evaluated. The quality of bowel preparation was evaluated using the Boston Bowel Preparation Scale. Safety was evaluated by adverse reactions. The study population was divided into the full analysis set (FAS), the safety set, the modified FAS (mFAS), and the per-protocol set (PPS). RESULTS: Three hundred forty-eight potentially eligible subjects were enrolled. Three hundred forty-four subjects were included in the FAS and safety set, 340 subjects were included in the mFAS, and 328 subjects were included in the PPS. Adequate bowel preparation of the OSS was not inferior to 3-L PEG in the mFAS (98.22% vs 97.66%) and the PPS (98.17% vs 98.78%). There was no significant difference in acceptability between the 2 groups (94.74% vs 94.80%, P = .9798). Overall adverse reactions were similar (50.88% vs 44.51%, P = .2370) between the 2 groups. CONCLUSIONS: The split-dose OSS regimen was not inferior to the split-dose 3-L PEG regimen for the quality of bowel preparation in a Chinese adult population. The safety and acceptability of the 2 groups were similar. (Clinical trial registration number: NCT05465889.).

Metal Versus Plastic Stents for Pancreatic Fluid Collection Drainage: A Systematic Review and Meta-analysis.

OBJECTIVES: The therapeutic efficacy of metal stents (MSs) for pancreatic fluid collections (PFCs) is invariably controversial. Here, we conducted a meta-analysis to summarize the results of efficacy of MSs and plastic stents (PSs) in PFC drainage. SUBJECTS AND METHODS: We performed a literature search of PubMed/MEDLINE, EMBASE, and COCHRANE for all of the published studies regarding the use of MSs and PSs for endoscopic transmural drainage of PFCs from January, 1 2015 to June 1, 2020. We extracted data from 9 studies (1359 patients) that met the inclusion criteria. The main outcome measures were the rates of treatment success, including technique success and clinical success (CS), adverse events, recurrence, procedure time, and length of hospital stay (LOS). RESULTS: There was no difference in overall technique success between patients treated with MSs and PSs for PFCs. However, MSs showed a higher CS rate 92% versus 82% (P<0.01) and a lower overall adverse event rate 20% versus 31% (P<0.01) than PSs. The recurrence rate of PFCs using MSs also had significant advantages over PSs 3% versus 10% (P<0.01) and MSs needed a shorter procedure time than PSs (26.73 vs. 45.40 min, P<0.01). In comparing direct endoscopic necrosectomy use and LOS, there was no difference between MSs and PSs. CONCLUSIONS: Bringing together the results of the current study, endoscopic ultrasound-guided drainage of PFCs using MSs may be superior to PSs in terms of CS, adverse events rates and recurrence rate, with similar LOS and direct endoscopic necrosectomy use.

The role of solid debris in endoscopic ultrasound-guided drainage of walled-off necrosis: A large cohort study.

BACKGROUND AND AIM: The effect of solid debris on walled-off necrosis (WON) drainage remains unknown. Our study evaluated the role of solid debris in endoscopic ultrasound (EUS)-guided drainage of WON compared lumen-apposing metal stent (LAMS) with double-pigtail plastic stent (DPPS). METHODS: We retrospectively evaluated consecutive patients with WON who underwent EUS-guided drainage in our endoscopic center over a 9-year period. The amount of solid debris in WON was assessed with computed tomography or magnetic resonance imaging and EUS images. RESULTS: From 2011 to 2019, 84 WON patients were included. In WON with < 20% solid debris, the short-term clinical success of LAMSs (96.8%) was significantly higher than DPPSs (66.7%) (P = 0.03), and LAMSs were safer than DPPSs with less early adverse events (P = 0.02) and late adverse events (P = 0.03). On multivariable analysis, DPPS (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.04-0.65; P = 0.01) and solid debris > 40% (OR, 0.11; 95% CI, 0.02-0.62; P = 0.01) were the predictors for failure of resolution of WON after adjusting for age and cyst size. The number of DPPSs used was significantly higher than LAMSs in managing WONs (P < 0.001). CONCLUSION: For WON with < 20% solid debris, LAMSs might superior to DPPSs in terms of efficacy and safety.

Effect of supplemental simethicone for bowel preparation on adenoma detection during colonoscopy: A meta-analysis of randomized controlled trials.

BACKGROUND AND AIM: Although several randomized controlled trials (RCTs) have reported that supplemental simethicone (SIM) can improve bowel preparation based on polyethylene glycol, there is no consensus as to whether SIM can ultimately increase the adenoma detection rate (ADR) during colonoscopy. A meta-analysis was performed to assess the effect of SIM on ADR during colonoscopy. METHODS: Databases including PubMed, EMBASE, and the Cochrane Library were searched to find relevant RCTs. RCTs evaluating the effect of pre-procedure SIM on the ADR during colonoscopy were finally included, and fixed effect models were applied. RESULTS: Six trials involving 1855 patients were finally included. The present meta-analysis suggested that the ADR during colonoscopy was significantly increased by supplemental SIM (27.9% vs 23.3%, P = 0.02), with a relative risk of 1.20 (95% confidence interval 1.03-1.39). Subgroup analysis suggested that supplemental SIM may be more useful to improve ADR during colonoscopy in endoscopic centers with low baseline ADR. CONCLUSIONS: Supplemental SIM for bowel preparation based on polyethylene glycol is useful to improve the ADR during colonoscopy.

Repetitive Position Change Improves Gastric Cleanliness for Magnetically Controlled Capsule Gastroscopy.

BACKGROUND AND AIMS: Good gastric preparation is essential for magnetically controlled capsule gastroscopy (MCCG) examination. This study aims to determine if repetitive position change after dimethicone premedication could further improve gastric cleanliness for MCCG. METHODS: Consecutive patients referred for MCCG in our center from May 7 to May 31, 2018 were prospectively enrolled and randomized to undergo repetitive position change for 15 min (position change group) or not (conventional group) after ingesting dimethicone. Primary outcome was gastric cleanliness score and secondary outcomes were detection rate of positive findings, number of lesions per patient, gastric examination time, and safety of MCCG. RESULTS: Totals of 43 and 40 were included in the position change and conventional groups, respectively. Gastric cleanliness score in the position change group was significantly higher than in the conventional group (21.2 ± 1.0 vs. 18.6 ± 2.0, P  < 0.001), as was the proportion of acceptable gastric cleanliness (gastric cleanliness score ≥ 18) (100% vs. 72.5%, P  < 0.001). There was no statistical difference in detection rate of positive findings between the two groups (27.9% vs. 27.5%, P  = 0.97). In the position change group, the gastric examination time was significantly reduced (13.2 ± 4.0 vs. 15.3 ± 5.1, P = 0.043). No adverse events were observed. CONCLUSIONS: Repetitive position change after dimethicone premedication significantly improves gastric cleanliness for MCCG examination. Clinical Trial Registration ClinicalTrials.gov, ID: NCT03514966.

Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial.

BACKGROUND AND STUDY AIMS: Ideal bowel preparation for colonoscopy requires complete removal of fluid and foam from the colon. Polyethylene glycol (PEG) is widely used for bowel preparation, with antifoaming agents such as simethicone commonly used in combination with PEG. Data on the effect of simethicone on the adenoma detection rate (ADR) were limited. This study therefore aimed to investigate whether preprocedure simethicone could increase the ADR. PATIENTS AND METHODS: This was a prospective, multicenter, endoscopist-blinded randomized controlled trial involving consecutive patients who underwent colonoscopy in six centers in China. Patients were randomly assigned to one of two groups: PEG plus simethicone or PEG alone. The primary outcome was ADR; secondary outcomes were quality of bowel preparation, measured by the Boston bowel preparation scale (BBPS) and bubble scores. RESULTS: 583 patients were included. More adenomas were detected in the PEG plus simethicone group than in the PEG alone group (ADR 21.0 % vs. 14.3 %, P = 0.04; advanced ADR 9.0 % vs. 7.0 %, P = 0.38). The mean number of adenomas detected was 2.20 ±â€Š1.36 vs. 1.63 ±â€Š0.89 (P = 0.02). Patients in the PEG plus simethicone group showed better bowel cleansing efficacy: BBPS ≥ 6 in 88.3 % vs. 75.2 % (P < 0.001) and bubble scores of 1.00 ±â€Š1.26 vs. 3.98 ±â€Š2.50 (P < 0.001). Abdominal bloating was reported less frequently in the PEG plus simethicone group (7.8 % vs. 19.7 %, P < 0.001) than in the PEG alone group. CONCLUSION: Combined use of PEG and simethicone is associated with a significantly increased ADR in a Chinese population.

Deployment of carboxymethyl cellulose sheets to prevent esophageal stricture after full circumferential endoscopic submucosal dissection: A porcine model.

BACKGROUND AND AIM: Esophageal stricture is a serious adverse event secondary to extensive endoscopic submucosal dissection (ESD). The present study aimed to investigate the efficacy of carboxymethyl cellulose (CMC) sheets for the prevention of esophageal stricture after full circumferential ESD in an animal model. METHODS: Fourteen porcine models were randomized into a control group (n = 7) and a CMC group (n = 7). Five-centimeter-long circumferential esophageal ESD was carried out at a distance of 40 to 45 cm from the incisors in all models. In the CMC group, CMC sheets were placed over the mucosal defect completely after ESD, whereas the control group underwent routine ESD only. Endoscopic examination was conducted after the first and second week post-ESD. Esophageal specimens were harvested during post-mortem and were evaluated for macroscopic and histological appearance. Blood serum levels of four pro-inflammatory or profibrotic cytokines were measured quantitatively. RESULTS: The CMC group had better food tolerability during the second week post-ESD. The CMC group showed a significantly lower esophageal mucosal stricture rate compared to the control group. Histological assessments showed less fibrosis in the submucosal layer, milder damage to the muscularis propria, and enhanced re-epithelization in the CMC group. Serum transforming growth factor beta 1 levels were significantly lower in the CMC group post-ESD. CONCLUSION: Deployment of CMC sheets on the mucosal defect appears to be a promising method for preventing esophageal strictures after extensive ESD.

Impact of gum chewing on the quality of bowel preparation for colonoscopy: an endoscopist-blinded, randomized controlled trial.

BACKGROUND AND AIMS: Gum chewing can accelerate motility in the GI tract; clinical studies suggested gum chewing can reduce postoperative ileus. However, no trial has investigated the effect of gum chewing on bowel preparation for colonoscopy in addition to polyethylene glycol (PEG). The objective of this study was to investigate whether gum chewing before colonoscopy can increase the quality of bowel preparation. METHODS: This was a single-center, randomized controlled trial. Consecutive patients undergoing colonoscopy were randomized to the gum group or the control group. Patients in the gum group chewed sugar-free gum every 2 hours for 20 minutes each time from the end of drinking 2 L of PEG to the beginning of colonoscopy. Patients in the control group only received 2 L of PEG before colonoscopy. The quality of bowel preparation, procedure time, adenoma detection rate, patients' tolerance, and adverse events were compared. RESULTS: Three hundred patients were included in the study (150 in the control group, 150 in the gum group). More than 90% of patients in both groups were satisfied with the process of bowel preparation, and the incidence of adverse events was comparable in the 2 groups (41.3% vs 46.0%, P = .42). The mean Boston Bowel Preparation Scale score was 6.2 ± 1.4 and 6.1 ± 1.2 in the control group and the gum group, respectively, and the difference between the 2 groups was not significant (P = .51). CONCLUSIONS: This study indicates that gum chewing does not improve the quality of bowel preparation for colonoscopy, but it can improve patients' satisfaction with the process of bowel preparation and does not have negative effects on cleanliness. (Clinical trials registration number: NCT02507037.).

pH-responsive CuS/DSF/EL/PVP nanoplatform alleviates inflammatory bowel disease in mice via regulating gut immunity and microbiota.

The clinical treatment of inflammatory bowel disease (IBD) is challenging. We developed copper sulfate (CuS)/disulfiram (DSF)/methacrylic acid-ethyl acrylate copolymer (EL)/polyvinylpyrrolidone (PVP) nanoplatform (CuS/DSF/EL/PVP) and evaluated its efficiency for treating IBD. After oral administration, the pH-sensitive EL protected the CuS/DSF/EL/PVP against degradation by acidic gastric juices. Once the colon was reached, EL was dissolved, releasing DSF and Cu2+. Further, the main in vivo metabolite of DSF can bind to Cu2+ and form copper (II) N, N-diethyldithiocarbamate (CuET), which significantly alleviated acute colitis in mice. Notably, CuS/DSF/EL/PVP outperformed CuS/EL/PVP and DSF/EL/PVP nanoplatforms in reducing colonic pathology and improving the secretion of inflammation-related cytokines (such as IL-4 and IL-10) in the colonic mucosa. RNA-seq analysis revealed that the nanoplatform reduced colonic inflammation and promoted intestinal mucosal repair by upregulating C-type lectin receptor (CLR)-related genes and signaling pathways. Furthermore, CuS/DSF/EL/PVP showed potential for improving colitis Th1/Th17 cells through innate immunity stimulation, down-regulation of inflammatory cytokines, and upregulation of anti-inflammatory cytokines. Additionally, the intervention with CuS/DSF/EL/PVP led to increased intestinal flora diversity, decreased Escherichia-Shigella abundance, and elevated levels of short-chain fatty acid (SCFA)-producing bacteria Prevotella, Lactobacillus, and Bifidobacterium, indicating their potential to modulate the dysregulated intestinal flora and suppress inflammation. STATEMENT OF SIGNIFICANCE: Our study introduces the CuS/DSF/EL/PVP nanoplatform as a therapeutic strategy for treating inflammatory bowel disease (IBD). This approach demonstrates significant efficacy in targeting the colon and alleviating acute colitis in mice. It uniquely modulates gut immunity and microbiota, exhibiting a notable impact on inflammation-related cytokines and promoting intestinal mucosal repair. The nanoplatform's ability to regulate gut flora diversity, combined with its cost-effective and scalable production, positions it as a potentially transformative treatment for IBD, offering new avenues for personalized medical interventions.

Microplastics are detected in human gallstones and have the ability to form large cholesterol-microplastic heteroaggregates.

Ubiquitous pollution due to microplastics through the food chain is a major cause of various deleterious effects on the human health. The aim of this study was to determine the existence of microplastics and the internal mechanism of microplastics as accelerators of cholelithiasis. Gallstones were collected from 16 patients after cholecystectomy, and microplastics in the gallstones were detected through laser direct infrared and pyrolysis gas chromatographymass spectrometry examinations. Mice model of gallstone were constructed with or without different diameters of microplastic (0.5, 5 and 50 µm). The affinity between microplastic and cholesterol or bilirubin was tested by co-culturing and qualified using molecular dynamics simulations. Finally, altered gut microbiota among the groups were identified using 16 s rRNA sequencing. The presence of microplastics in the gallstones of all the patients were confirmed. Microplastic content was significantly higher in younger chololithiasis patients (age<50 years). Mice fed a high-cholesterol diet with microplastic drinks showed more severe chololithiasis. In terms of the mechanism, microplastics showed a higher affinity for cholesterol than for bilirubin. Significant alterations in the gut microbiota have also been identified after microplastic intake in mice. Our study revealed the presence of microplastics in human gallstones, showcasing their potential to aggravate chololithiasis by forming large cholesterol-microplastic heteroaggregates and altering the gut microbiota.

Biomaterials for Helicobacter pylori therapy: therapeutic potential and future perspectives.

Helicobacter pylori (H. pylori) is the main cause of gastric adenocarcinoma. However, the traditional antibiotic treatment of H. pylori is limited due to increased antibiotic resistance and low efficacy; low drug delivery efficiency and difficulties in eradicating H. pylori that is present intracellularly or in biofilms cause further setbacks. Biomaterials that can protect drugs against stomach acid, target lesions, control drug release, destroy biofilms, and exhibit unique antibacterial mechanisms and excellent biocompatibility have emerged as attractive tools for H. pylori eradication, particularly for drug-resistant strains. Herein, we review the virulence mechanisms, current drug treatments, and antibiotic resistance of H. pylori strains. Furthermore, recent advances in the development of biomaterials, including nanoparticles (such as lipid-based nanoparticles, polymeric nanoparticles, and inorganic nanoparticles), microspheres, and hydrogels, for effective and precise therapy of H. pylori and different types of therapeutic mechanisms, as well as future perspectives, have also been summarized.

Trends of calcium silicate biomaterials in medical research and applications: A bibliometric analysis from 1990 to 2020.

Background: Calcium silicate biomaterials (CSB) have witnessed rapid development in the past 30 years. This study aimed to accomplish a comprehensive bibliometric analysis of the published research literature on CSB for biomedical applications and explore the research hotspot and current status. Methods: Articles related to CSB published in the last three decades (1990-2020) were retrieved from Web of Science Core Collection. The R bibliometrix package and VOSviewer were used to construct publication outputs and collaborative networking among authors, their institutes, countries, journals' matrices and keywords plus. Results: A total of 872 publications fulfilling the search criteria were included. CSB is mainly reported for bone tissues and dental applications. Among researchers, Chang J from Chinese Academy of Sciences and Gandolfi MG from the University of Bologna are the most productive author in these two fields, respectively. China was the leading contributor to the research on CSB in the medical field. A total of 130 keywords appeared more ten or more times were identified. The term "mineral trioxide aggregate" ranked first with 268 occurrences. The co-occurrence analysis identified three major clusters: CSB in dentistry, bone tissue and vitro bioactivity. Conclusion: Calcium silicate biomaterials have a promising scope for various biomedical applications ranging from regeneration of hard tissues (bone and teeth) to skin, tumor, cardiac muscle and other soft tissues. This study may help researchers further understand the frontiers of the field.

Endoscopic retrieval of a migrated pancreatic stent stuck at both ends: A case report.

Background: Endoscopic pancreatic stenting is an effective way to relieve the stricture of the pancreatic duct. However, proximal stent migration presents a threat to the patient and a challenge to the doctor. The limited space in the pancreatic duct often prevents the operation of suitable devices for stent removal. Case presentation: A 34-year-old man with painful chronic pancreatitis received endoscopic retrograde cholangiopancreatography (ERCP) and insertion of a pancreatic plastic stent, with 8.5 Fr in diameter and 12 cm in length. A year later, radiography revealed that the proximal end of the stent rested in the pancreatic tail while the distal end rested in the branch duct. Both balloon and rat-tooth forceps were used but failed to retrieve the stent. A week later, a second ERCP was performed. After dilation with a 10-mm balloon, a small amount of bleeding was noticed and a crack appeared in the wall of the branch duct. Consequently, the distal end of the stent was released. Then, rat-tooth forceps was used to grasp the distal end, and the stent was pulled out successfully. Conclusions: For a proximally migrated pancreatic stent stuck at both ends, a strategy of maximum dilation can be used cautiously to retrieve the stent.

Photothermal transforming agent and chemotherapeutic co-loaded electrospun nanofibers for tumor treatment.

Background: Photothermal and chemotherapy treatment has been frequently studied for cancer therapy; however, chemotherapy is equally toxic to both normal and cancer cells. The clinical application value of most kinds of photothermal transforming agents remains limited, due to their poor degradation and minimal accumulation in tumors. Materials and methods: We reported the synthesis of photothermal transforming agents (MoS2) and chemotherapeutic (doxorubicin, DOX) co-loaded electrospun nanofibers using blend electrospinning for the treatment of postoperative tumor recurrence. Results: Under the irradiation of an 808 nm laser, the as-prepared chitosan/polyvinyl alcohol/MoS2/DOX nanofibers showed an admirable photothermal conversion capability with a photothermal conversion efficiency of 23.2%. These composite nanofibers are in vitro and in vivo biocompatible. In addition, they could control the sustained release of DOX and the generated heat can sensitize the chemotherapeutic efficacy of DOX via enhancing its release rate. Their chemo-/photothermal combined therapy efficiency was systematically studied in vitro and in vivo. Instead of circulating with the body fluid, MoS2 was trapped by the nanofibrous matrix in the tumor and so its tumor-killing ability was not compromised, thus rendering this composite nanofiber a promising alternative for future clinical translation within biomedical application fields. Conclusion: Chitosan/polyvinyl alcohol/MoS2/DOX nanofibers showed an excellent photothermal conversion capability with a photothermal conversion efficiency of 23.2% and can completely inhibit the postoperative tumor reoccurrence.

A novel approach for treatment of unresectable pancreatic cancer: design of radioactive stents and trial studies on normal pigs.

PURPOSE: Patients diagnosed with pancreatic cancer typically have a poor prognosis. The aims of these studies were to design radioactive stents and to evaluate the feasibility and safety of the stents in animals. EXPERIMENTAL DESIGN: To combine the effects of stents and brachytherapy, plastic stents with inserted iodine-125 seeds were designed and tested in 18 normal pigs. The pigs were divided into five groups on the basis of radiation dose. The estimated radiation dose at a 5-mm radial distance from the axis of the seeds was 50 Gy in group A, 100 Gy in group B, 150 Gy in group C, and 200 Gy in group D, with four pigs in each group. In the control group (n = 2), the same plastic stents with non-radioactive seeds were implanted in the pancreatic duct. RESULTS: The procedures were successfully done on 14 of 18 (78%) pigs, whereas pancreatic duct perforation occurred in four pigs (22%). The thickened wall of the dilated pancreatic duct was clearly observed in the control group. However, the normal morphologic structure of the pancreatic duct wall disappeared in the experimental groups. Histopathologic examination revealed that the stents were surrounded with necrotic tissues and lateral fibrous tissues. During the follow-up period, the width of outside fibrous tissues gradually increased. CONCLUSIONS: These results indicate that the radioactive stents are safe in all dose groups, and it is feasible to design a special radioactive stent for each patient according to the size, shape, and position of the pancreatic tumor.

Self-expandable metal stents and trans-stent light delivery: are metal stents and photodynamic therapy compatible?

BACKGROUND AND OBJECTIVES: Obstructive non-small cell lung cancer and obstructive esophageal cancer are US FDA approved indications of photodynamic therapy (PDT). The usefulness of PDT for the treatment of cholangiocarcinoma is currently under clinical investigation. Endoscopic stenting for lumen restoration is a common palliative intervention for those indications. It is important to assess whether self-expandable metal stents are compatible with trans-stent PDT light delivery. STUDY DESIGN/MATERIALS AND METHODS: Direct effects of various components of metal biliary (n = 2), esophageal (n = 2), and bronchial (n = 1) stents on PDT light transmittance and distribution were examined using a point or linear light source (630 or 652 nm diode laser). Resected pig biliary duct and esophageal wall tissues were used to examine the feasibility of PDT light delivery through the fully expanded metal stents. RESULTS: While using a point light source, the metal components (thread and joint) of the stent could cause a significant shadow effect. The liner material (polytetrafluoroethylene or polyurethane) could cause various degrees of light absorption. When the stent was covered with a thin layer of biliary duct and esophageal tissues containing all wall layers, the shadow effect could be mitigated due to tissue scattering. CONCLUSIONS: This study clearly demonstrates that it is feasible to combine stenting and PDT for the treatment of luminal lesions. PDT light dose should be adjusted to counteract the reduction of light transmittance caused by the metal and liner materials of stent.