Endoscopy. One, or more, imaging techniques associated with endoscopic apparatus, including, without limitation, such apparatus producing pseudo-color images of body tissues (“Endoscopy”).
Endoscopy. The Department of Gastroenterology and Endoscopy provides inpatient and outpatient treatment and diagnosis for patients with diseases or disorders of the gastro-intestinal system within NHSG, providing services also for NHS Orkney and Shetland. There are three distinct sub-specialisms within the department, though the specific service affected by this proposal is endoscopy: Luminal Gastroenterology Hepatology Endoscopy Endoscopy services are predominantly provided at ARI though these are also undertaken in Xx Xxxx’x Hospital and at the Aberdeen Health Village (by a 3rd party) and via the Community Hospital Scoping Service – available in Aboyne, Banff, Peterhead, and Stonehaven, undertaken by trained GPs. A ‘hub and spoke’ type model is in place with XXX accepting more complex clinical work and other centres focusing more on disease exclusion. Endoscopic inpatient and day case diagnostic and therapeutic interventions are delivered by Gastroenterologists, General Surgeons, Nurse Endoscopists and GPs with special interest. The Endoscopy service is provided at four sites within ARI. The main endoscopic interventions are grouped under the following: Diagnostic Bowel Screening Emergency Interventional/therapeutic procedures The Endoscopy unit at ARI has three endoscopy rooms. Each room can support two lists per day and each list has a total of 10 or 12 ‘slots’. Each procedure is allocated a number of required slots: Colonoscopy three slots Upper GI one slot Flexible Sigmoidoscopy one slot Endoscopy/colonoscopy four slots Demand for colonoscopy has been increasing in the last 3 years as indicated in table S2 below, which shows net additions of patients to waiting lists. There has been a 60% increase in demand for repeat colonoscopy procedures over the 3 year period 2013/14 to 216/17. As is shown in tables S3 and S4, demand for repeat Sigmoidoscopy and Upper GI and has increased by 50% and 25% during the same period. Maintaining activity has been challenging for Colonoscopy which has also experienced increased demand, although activity has also been higher since 2015/16 as an artefact of the 3rd party contract to provide additional Endoscopy activity at the Aberdeen Health Village (AHV) and linked to Waiting List Initiatives. Table S2: Colonoscopy Demand Colonoscopy Demand FY1112 FY1213 FY1314 FY1415 FY1516 FY1617 ARI Booked New Day Case 4296 4011 3759 3787 4552 4655 Repeat Day Case 1012 1095 1007 1230 1618 1609 New Inpatient 297 209 213 182 ...
Endoscopy. Hours of on-call will be 4:00pm Friday through 7:00am Monday Holiday on-call will be 4:00pm the day before the holiday until 7:00am the day after the holiday. On call during the week will be on a voluntary basis. In the event that there are volunteers, the general provisions for on-call listed above shall apply.
Endoscopy. Endoscopic examination was performed at Gastroenterology and Gastrointestinal Endoscopy Unit of Siena University Hospital. In all cases chromoendoscopy with indigo xxxxxxx solution (0.5-1.0 %) was used to obtain a precise analysis and classification of the lesions. The elevation or depression of superficial lesions was evaluated with a millimeter scale for the columnar epithelium according to guidelines of Japanese Gastric Cancer Association (11). All endoscopic images, at least 4 per case, were stored electronically for later evaluation using Image Bank Software (United Medical Software- Italy). Endoscopic images were reviewed and the diagnoses confirmed in photographs by the same endoscopists who had made the original diagnoses, according to Paris classification (Table 1). These photographs, without any diagnostic indications, were then sent to Japanese endoscopists working at the National Cancer Center in Tokyo, who subtyped them and sent their diagnoses back to the endoscopists in Siena. A complete intra- and interobserver agreement was reached among Italian endoscopists and among Japanese endoscopists.
Endoscopy. ■ Response and remission as assessed by change in SES-CD score as continuous variable ■ Preferred over CDEIS ■ Central read (e.g., Robarts or BioClinica) ■ Proportion of patients with a 25% or 50% change from baseline in SES-CD ○ PoM endpoints ■ Circulating myeloid cells by flow cytometry [Possibly the fastest endpoint to change in the study] ■ Mucosal Histology (biopsies at baseline and end of study): reduction in inflammatory myeloid cells (DC1, Macrophages) ■ Mucosal mRNA signature: reduction in disease signature, compared to anti-TNF and other benchmarks available [This is the most sensitive endpoint. We will use Jxxxxxx’x tissue mRNA data as benchmark and should see a change if the drug works] ○ PROs ■ Novel Crohn’s endpoint based on SF and AP ○ Biomarkers of inflammation ■ Change in serum CRP: analysis of the subgroup with elevated CRP at baseline ■ Stool calprotectin: reduction in FCP (stool also stored for potential future microbiome analysis), thresholds in fecal calprotectin such as those with FC < 250 or FC <500. - OPERATIONAL CONSIDERATIONS (BASED ON RECENT EXPERIENCE) ○ Countries ■ Target 70% Eastern Europe (Ukraine, Hungry, Poland, Russia) and 30% US/Canada (possible: select EU countries such as Germany, Spain) ○ Enrollment estimates for 70-90 patients ■ Eastern Europe, approximately 0.2-0.3 patients/site/month ■ US/Canada approximately 0.1-0.2 patients/site/month ○ Scree-Failure rate ■ Assuming 50% ○ Number of active sites: ■ 40-50 sites ■ US/Canada: ~20 sites ■ Ukraine: ~10 sites ■ Poland: ~5 sites ■ Hungary: ~5 sites ■ Russia:~5 sites ○ Examples of CROs to be evaluated ■ PSI, Easthorn, Arensia for Eastern Europe ■ Robarts vs Bioclinica for endoscopy ○ Consider also at-home/in-pharmacy visits and remote data collection with the goal of improving ‘enrolability’ and reduce costs.
