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Background: Global health systems are shifting toward value-based health care to improve patient outcomes in the face of rising health care costs. The challenge is to identify standardized outcome measurements that allow optimal quality-of-care monitoring and comparison to optimize medical practices and patient pathways. A common outcomes definition is required, including medical results (Clinical Reported Outcomes Measurements [CROMs]) and quality-of-life components that matter most to patients (Patient-Reported Outcomes Measurements [PROMs]), which are particularly important for severe pathologies with short life expectancy such as pancreatic cancer. This study aimed to create standardized metrics that could be used for outcomes analysis of pancreatic cancer care. Methods: A multidisciplinary working group (WG) was assembled. A systematic review was performed to collect the most used outcomes in clinical studies of pancreatic cancers. The study reviewed 570 studies published in the last 10 years. From these studies, 3370 outcomes, including CROMs, and PROMs, were listed and prioritized. The WG reached a consensus on key outcomes, proposed groupings for CROMs and PROMs, identified existing questionnaires that could be used for PROMs collection, and set the timeline for data collection. To refine and validate the final outcomes set, an international external committee completed a Delphi process (two rounds for both CROMS and PROMs). Results: After the systematic literature review, the WG selected 102 outcomes (92 CROMs and 10 PROMs) for submission to the international Delphi vote committee. The committee retrained 89 outcomes (78 CROMs and 11 PROMs). For the PROMs, the WG and the international external committee chose a validated questionnaire, the Functional Assessment of Cancer Therapy-Hepatobiliary, which covers all of the 11 selected PROMs. Conclusions: A standardized set of outcome measures that need to be validated through international health outcome comparisons and quality-of-care assessments was built. Pilot projects are underway to test and optimize the approach in real-life conditions. [ABSTRACT FROM AUTHOR]

Objectives: The goal was to demonstrate the utility of open-source tracking and visualisation tools in the targeting of lung cancer. Material and methods: The study demonstrates the first deployment of the Anser electromagnetic (EM) tracking system with the CustusX image-guided interventional research platform to navigate using an endobronchial catheter to injected tumour targets. Live animal investigations validated the deployment and targeting of peripheral tumour models using an innovative tumour marking routine. Results: Novel tumour model deployment was successfully achieved at all eight target sites across two live animal investigations without pneumothorax. Virtual bronchoscopy with tracking successfully guided the tracked catheter to 2–12 mm from the target tumour site. Deployment of a novel marker was achieved at all eight sites providing a reliable measure of targeting accuracy. Targeting accuracy within 10 mm was achieved in 7/8 sites and in all cases, the virtual target distance at marker deployment was within the range subsequently measured with x-ray. Conclusions: Endobronchial targeting of peripheral airway targets is feasible using existing open-source technology. Notwithstanding the shortcomings of current commercial platforms, technological improvements in EM tracking and registration accuracy fostered by open-source technology may provide the impetus for widespread clinical uptake of electromagnetic navigation in bronchoscopy. [ABSTRACT FROM AUTHOR]

Background: Gastroparesis is a rapidly increasing problem with sometimes devastating consequences. While surgical treatments, particularly laparoscopic pyloroplasty, have recently gained popularity, they require general anesthesia, advanced skills, and can lead to leaks. Peroral pyloromyotomy is a less invasive alternative; however, this technique is technically demanding and not widely available. We describe a hybrid laparo-endoscopic collaborative approach using a novel gastric access device to allow endoluminal stapled pyloroplasty as an alternative treatment option for gastric outlet obstruction.Methods: Under general anesthesia, six pigs (mean weight 33 kg) underwent endoscopic placement of intragastric ports using a technique similar to percutaneous endoscopic gastrostomy. A 5 mm laparoscope was used for visualization. A functional lumen imagine probe was used to measure the cross-sectional area (CSA) and diameter of the pylorus before, after, and at 1 week after intervention. Pyloroplasty was performed using a 5 mm articulating laparoscopic stapler. Gastrotomies were closed by endoscopic clips, endoscopic suture, or combination. After 6-8 days, a second evaluation was performed. At the end of the protocol, all animals were euthanized.Results: Six pyloroplasties were performed. In all cases, this technique was effective in achieving significant pyloric dilatation. The median pre-pyloroplasty pyloric diameter (D) and cross-sectional area (CSA) were 8 mm (4.9-11.6 mm) and 58.6 mm2 (19-107 mm2), respectively. After the procedure, these values increased to 13.41 mm (9.8-17.6 mm) and 147.7 mm2 (76-244 mm2), respectively (p = 0.0152). No important intraoperative events were observed. Postoperatively, all animals did well, with adequate oral intake and no relevant complications. At follow-up endoscopy, all incisions were healed and the pylorus widely patent.Conclusions: Hybrid endoluminal stapled pyloroplasty is a feasible, safe, and effective alternative method for the treatment of gastric outlet obstruction syndrome. [ABSTRACT FROM AUTHOR]

Flexible endoscopy has evolved to the point that it includes many endoluminal procedures that once required open or laparoscopic surgery, for instance, antireflux surgery, pyloromyotomy, mucosal and submucosal tumor resections, and even full-thickness resection. However, these procedures remain technically demanding due to flexible technology issues: difficult imaging, limited energy devices, lack of staplers, unsatisfactory suturing abilities, and so on. Transgastric laparoscopy or hybrid laparoscopy/flex endoscopy has been described for almost two decades as an alternative to a pure endoluminal approach, mainly for pancreatic pseudocyst drainage and full-thickness and mucosal resection of various lesions. The approach has never been widely adopted mostly due to cumbersome and difficult to maintain methods of gastric access. We propose to expand the indications of transgastric laparoscopy by using novel endoscopically placed ports to replicate endoscopic procedures particularly in the difficult to access proximal stomach such as endoluminal antireflux surgery. Under general anesthesia, five female pigs (mean weight: 27.6 kg) had endoscopic placement of 3, 5 mm intragastric ports (Endo-TAGSS, Leakwood KS, USA) using a technique similar to percutaneous endoscopic gastrostomy. A 5-mm laparoscope was used for visualization. Laparoendoscopic-assisted plication of the gastroesophageal junction (GEJ) was performed using 3–0 interrupted sutures (Polysorb®, Covidien, Mansfield, MA, USA). A functional lumen imagine probe (EndoFLIP®, Crospon, Inc. Galway, Ireland) was used to measure diameter, cross sectional area (CSA), distensibility, and compliance of GEJ before and after intervention. Once the TAGSS ports were removed, the gastrotomies were closed by using endoscopic over-the-scope clips. At the end of the procedure, animals were euthanized. Five laparoendoscopic-assisted endoluminal plications were performed. The mean operative time was 65.6 min (Endoscopic evaluation: 3.2 min, TAGSS Insertion: 11 min, EndoFLIP evaluation + GEJ Plication: 43.25 min, gastric wall closure: 15 minutes). In all cases, this technique was effective and allowed to achieve an adequate GEJ plication by endoscopic grading and EndoFLIP measurements. Median pre-plication GEJ diameter (D) and median pre-plication GEJ cross-sectional area (CSA) were 11.42 mm (8.6–13.6 mm) and 104.8 mm2 (58–146 mm2). After the procedure, these values were decreased to 6.14 mm (5.7–6.6 mm) and 29.8 mm2 (25–34 mm2) respectively (p  = 0.0079). Median pre-plication distensibility (d) and compliance (C) were 7.87 mm2/mmHg (2.4–22.69 mm2/mmHg) and 190.56 mm3/mmHg (70.9–502.8 mm3/mmHg). After the procedure, these values decreased to 1.5 mm2/mmHg (0.7–2.2 mm2/mmHg) and 52.17 mm3/mmHg (21.9–98.7 mm3/mmHg) respectively (p  = 0.0317). No intraoperative events were observed. Endoscopically, all valves were felt to be transitioned from a Hill grade 3 (normal state for the animal model) to a Hill grade 1 at the procedure completion. A hybrid laparoendoscopic approach is a feasible alternative for performing intragastric procedures with the assistance of conventional laparoscopic instruments; especially in cases where the intervention location limits the access to standard endoscopy or where endoscopic technology is inadequate. Further evaluation is planned in survival models and clinical trials. [ABSTRACT FROM AUTHOR]