Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up ...(PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H - mean 93.0% 95%CI 90.2-95.4, AL-mean 89.7% 95%CI 85.9-92.9 and CL-mean 83.8% 95%CI 76.9-89.7. Pooled durable clinical success proportions were: H-mean 87.5% 95%CI 80.5-93.2, AL-mean 81.4% 95%CI 77.0-85.3 and CL-mean 63.0% 95%CI 53.0-72.3. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.
In a comparative study, reactions between 5-(
p-methoxyphenyl)-substituted 3-alkoxy-4-methylthiazole-2(3
H)-thiones and appropriate mediators (BrCCl
3, Bu
3SnH) provided higher yields of alkoxyl ...radical products (δ-bromohydrins, cyclic ethers, carbonyl compounds) than respective transformations of 5-phenyl- and 5-methyl-substituted derivatives. The unusual selectivity of applied thiohydroxamates to furnish products of O-alkylation, even upon treatment with soft carbon electrophiles, and the marked propensity of 3-alkoxy-5-(
p-methoxyphenyl)-4-methylthiazole-2(3
H)-thiones to crystallize, facilitated preparation and purification of the new family of alkoxyl radical precursors in a noteworthy manner.
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Radar systems have become more important in the automotive field, especially for autonomous driving. A crucial part of the hardware is the antenna which is connected by lines to the radar chip. These ...components are usually built on printed circuit boards (PCBs) that have to fulfill high automotive requests under all environmental conditions. As a consequence, material properties are a critical factor for the functionality and reliability of systems, like-wise new materials are available in the market. Fourteen interesting materials of different classes polytetrafluorethylene (PTFE), polyphenyl ether (PPE), epoxy-based resin, and liquid crystal polymer (LCP) were evaluated in this work at their initial state, while heating to 125 °C and after storage with 85% relative humidity (RH) at 85 °C. It is shown that there are new candidates for millimeter wave applications beyond the PTFE materials. Nevertheless, it is necessary to test each material individually for its properties and optimize the parameters in simulation because they differ from the values in the datasheet. In addition, the properties depend on the used line setup, in this work microstrip lines. For the measurements, multiline thru-reflect-line (TRL) calibration and ring resonators were used and give a good overview by loss and effective permittivity depending on the environmental condition.
Background
Reliable closure is a prerequisite for conventional and innovative endoscopic procedures, such as NOTES. The purpose of this study is the systematic evaluation of the procedural and ...clinical success rates in closure of iatrogenic gastrointestinal perforations and acute anastomotic leaks by means of the over-the-scope-clip system (OTSC
®
).
Design
PubMed and other sources were searched systematically for clinical and preclinical research on the evaluation of the OTSC System for closure of gastrointestinal perforations and leaks. Appraisal of studies for inclusion and data extraction was performed independently by two reviewers using an a priori determined data extraction grid. Major endpoints to be extracted were data on procedural success (successful clip application) and clinical access (durable closure of defect without secondary adjunct therapy).
Results
A total of 17 clinical research articles/abstracts and 22 preclinical research articles/abstracts were identified. The examined clinical studies comprised case series and clinical single-arm studies. The reviewed studies revealed a consistently high mean rate of procedural success of 80–100 % and durable clinical success of 57–100 %. An identified major drawback preventing successful clip application was occurrence of fibrotic or inflamed lesion edges. Usage of the OTSC System was accompanied by neither major clip-related nor application-related complication. In experimental settings, closure of larger perforations and gastric access sites of NOTES or endoscopic full-thickness resection were achieved with high rates of success.
Conclusions
Because randomized, clinical trials are not available in this field of indication, the evaluation is based on small case series. Nevertheless, by pooling all experience gained, we conclude that endoscopic closure of iatrogenic gastrointestinal perforations and acute anastomotic leaks by means of the OTSC System is a safe and effective method.
Background
Acute upper gastrointestinal bleeding is a life-threatening medical condition with a relevant risk of re-bleeding even after initial endoscopic hemostasis. The implantable HemoPill monitor ...contains a novel telemetric sensor to optically detect blood in the stomach allowing the surveillance of high-risk patients for re-bleedings.
Methods
In this pre-clinical porcine study, bleeding has been simulated by injecting porcine blood into the stomach of a pig through an implanted catheter using a syringe pump. The effect of the sensor position in the stomach, the gastric food content, and the bleeding intensity was investigated.
Results
Sensitivity and specificity of the sensor reached more than 87.5% when the sensor was positioned close to the source of bleeding. Solid food had a higher negative impact on sensitivity than liquid food but a positive impact on specificity. A heavy bleeding was more likely to be detected by the sensor but was also associated with a lower likelihood for true-negative results than weaker bleedings.
Conclusions
The study clearly demonstrated the capability of the HemoPill sensor prototype to detect clinically relevant bleedings with high sensitivity and specificity (> 80%) when the sensor was positioned close to the bleeding site. The sensors proved to be robust against artefact effects from stomach content. These are favorable findings that underline the potential benefit for the use of the HemoPill sensor in monitoring patients with a risk of re-bleeding in the upper gastrointestinal tract.
Background
The benefit of endoscopic full-thickness resection is the improved diagnostic work-up with an integral wall specimen which allows a precise determination of the tumor or its precursor and ...its infiltration depth into the wall.
Materials and methods
A new endoscopic full-thickness resection device (FTRD), which is a combination of a modified over-the-scope-clip (OTSC) system with an electrocautery snare, has been tested in an experimental setting. In eleven pigs, divided into three groups, endoscopic full-thickness resection was performed in the colon at one or two sites, respectively. Seven days (
n
= 7) or 28 days (
n
= 4) after the intervention, the animals were euthanized following endoscopic examination of the resection and clip application sites. Furthermore, two different clips were tested during these animal trials in order to evaluate the most effective clip design.
Results
The average diameter of the tissue resected with the FTRD was 3.1, 3.6, and 5.4 cm in the three groups. On follow-up endoscopy 7 days after the intervention, fibrin coating and stool residues were found at all clips, causing minor inflammatory reactions. However, the colon wall under the clip was non-inflamed. After 28 days, the serosa had primarily healed in all cases. There were also stool residues at all clips; however, no acute inflammatory reactions were seen anymore, due to complete healing. Histological assessment did not show any signs of dehiscence in the region of the scar, or ischemia in the clip area. In addition, no wound infections, such as abscess formation, were observed.
Conclusions
This study demonstrates the safety and efficacy of the clip-and-cut technique using the new FTRD system. With the device, a local full-thickness colon resection can be easily created, and the resulting wall defect is reliably sealed by the endoluminal application of a modified OTSC clip.
Acute upper gastrointestinal bleedings from ulcers or esophago-gastric varices are life threatening medical conditions which require immediate endoscopic therapy. Despite successful endoscopic ...hemostasis, there is a significant risk of rebleeding often requiring close surveillance of these patients in the intensive care unit (ICU). Any time delay to recognize bleeding may lead to a high blood loss and increases the risk of death. A novel telemetric real-time bleeding sensor can help indicate blood in the stomach: the sensor is swallowed to detect active bleeding or is anchored endoscopically on the gastrointestinal wall close to the potential bleeding source. By telemetric communication with an extra-corporeal receiver, information about the bleeding status is displayed. In this study the novel sensor, which measures characteristic optical properties of blood, has been evaluated in an ex-vivo setting to assess its clinical applicability and usability. Human venous blood of different concentrations, various fluids, and liquid food were tested. The LED-based sensor was able to reliably distinguish between concentrated blood and other liquids, especially red-colored fluids. In addition, the spectrometric quality of the small sensor (size: 6.5mm in diameter, 25.5mm in length) was comparable to a much larger and technically more complex laboratory spectrophotometer. The experimental data confirm the capability of a miniaturized sensor to identify concentrated blood, which could help in the very near future the detection of upper gastrointestinal bleeding and to survey high-risk patients for rebleeding.
Roux-en-Y gastric by-pass (RYGB) is one of the most effective bariatric procedures, but the rate of weight regain (WR) can reach 63% after the second year. Enlargement of the gastrojejunal ...anastomosis is one of the reported causes. A newly CE-marked flexible endoscopic system, Bariatric Anastomotic Reduction System (BARS) (Ovesco Endoscopy, Tuebingen, Germany), derivative of the well-established endoscopic over-the-scope-clip (OTSC) clipping system, has been recently developed. It was tested in pre-clinical and preliminary clinical use for feasibility and effectiveness in bariatric anastomotic reduction.
Using a single-channel endoscope with external supplemental working channel, the BARS device captures the two limbs of the anastomosis, reducing its size, thus slowing food passage. After preclinical assessment, six patients with at least a 15% WR and the presence of an enlarged gastrojejunostomy > 20 mm were enrolled. The mean patient age was 49 years (range 24-67). Average interval between gastric bypass and BARS procedure: 8 years (4-13).
All procedures were safely performed without complications. Mean procedure time: 52 min (37 − 75). Preliminary results: mean weight loss 6 kg (4-9) at a 3-month FU.
BARS could be a promising endoscopic system in case of WR after gastric bypass due to enlargement of the anastomosis.
Malignant ascites in ovarian carcinoma patients is associated with poor prognosis and reduced quality of life. The trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) enhances the antitumor ...activity by redirecting T cells and Fcgamma receptor I/III--positive accessory cells to the tumor. This multicenter phase I/II dose-escalating study investigated tolerability and efficacy of i.p. catumaxomab application in ovarian cancer patients with malignant ascites containing epithelial cell adhesion molecule (EpCAM)--positive tumor cells.
Twenty-three women with recurrent ascites due to pretreated refractory ovarian cancer were treated with four to five i.p. infusions of catumaxomab in doses of 5 to 200 microg within 9 to 13 days.
The maximum tolerated dose was defined at 10, 20, 50, 200, and 200 microg for the first through fifth doses. Side effects included transient fever (83%), nausea (61%), and vomiting (57%), mostly CTCAE (Common Terminology Criteria for Adverse Events) grade 1 or 2. A total of 39 grade 3 and 2 grade 4 treatment-related adverse events (AE), 9 of them after the highest dose level (200 microg), were observed in 16 patients. Most AEs were reversible without sequelae. Treatment with catumaxomab resulted in significant and sustained reduction of ascites flow rate. A total of 22/23 patients did not require paracentesis between the last infusion and the end of study at day 37. Tumor cell monitoring revealed a reduction of EpCAM-positive malignant cells in ascites by up to 5 log.
I.p. immunotherapy with catumaxomab prevented the accumulation of ascites and efficiently eliminated tumor cells with an acceptable safety profile. This suggests that catumaxomab is a promising treatment option in ovarian cancer patients with malignant ascites.
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