The development of new endoscopic methods is advancing rapidly. Current standard methods such as endoscopic balloon dilatation have only limited long-term effects. Surgery is more effective, but it also carries a higher risk of complications. Endoscopic stricturotomy and stricturoplasty are new methods expanding the range of possibilities of endoscopic treatment. These methods are advanced, technically demanding, and require adequate expertise and training. It is, therefore, necessary to have a tool for training and teaching these new methods. The live large animal model is a valuable tool in the development and testing of new, difficult, and dexterity intensive therapeutic methods thanks to its natural properties including bowel movements and tissue reactions such as swelling or bleeding. Animal model simulating secondary stricture in the site of the entero-colonic anastomosis has been created allowing not only to practice but also to develop new minimally invasive endoscopic techniques for the treatment of strictures in Crohn's disease (CD). High cost and stringent legislation represent the main limitations of more widespread use of large animal models in endoscopy.
- MeSH
- Crohn Disease * complications surgery MeSH
- Dilatation methods MeSH
- Endoscopy, Gastrointestinal methods MeSH
- Humans MeSH
- Swine MeSH
- Retrospective Studies MeSH
- Constriction, Pathologic etiology surgery MeSH
- Treatment Outcome MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
BACKGROUND AND AIMS: Currently, treatment options in postsurgical recurrence of stricturing Crohn's disease (CD) are limited. However, development of new invasive endoscopic techniques in clinical practice has safety constraints. The aim of this study was to create a large animal model of anastomotic stricture with CD properties to enable development of new techniques and training. METHODS: A side-to-side ileocolonic anastomosis was created in a modified Roux-en-Y manner with bowel continuity preserved. Two weeks after surgery, we began endoscopic submucosal injections of phenol/trinitrobenzenesulfonic acid solution. This solution was injected every 2 weeks in each quadrant of the anastomosis until development of a stricture. The anastomosis site was assessed endoscopically 2 weeks after the last application (baseline) and then every 2 months until month 6. Endoscopically nonpassable strictures were treated with balloon dilation, endoscopic stricturotomy, and stent placement to confirm the feasibility of such interventions. RESULTS: Nineteen minipigs were included with no postoperative adverse events. After a mean of 4.4 ± .7 injection sessions with 10.5 ± 3.0 mL of the solution, anastomotic strictures were created in 16 pigs (84.2%). Mean diameter of the strictures at baseline was 11.6 ± 2.2 mm. The strictures were inflamed, and the endoscope could not pass. Follow-up was successfully completed in 15 animals (79.0%) with the mean deviation from the initial diameter in every measurement of -.02 ± 2.26 mm (P = .963) and a mean final diameter of 11.7 ± 3.4 mm. The histopathologic evaluation revealed the presence of submucosal fibrosis, chronic inflammation, and microgranulomas. All strictures were amenable to endoscopic therapeutic interventions. CONCLUSIONS: We developed a novel, reproducible porcine model of anastomotic stricture with histologically verified changes mimicking CD and stable diameter for more than 6 months. It is suitable for further endoscopic interventions.
- MeSH
- Crohn Disease * surgery MeSH
- Dilatation MeSH
- Endoscopy MeSH
- Humans MeSH
- Swine, Miniature MeSH
- Swine MeSH
- Retrospective Studies MeSH
- Constriction, Pathologic etiology MeSH
- Treatment Outcome MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- MeSH
- Crohn Disease drug therapy MeSH
- Inflammatory Bowel Diseases * drug therapy MeSH
- Interleukin-12 physiology MeSH
- Interleukin-23 physiology MeSH
- Clinical Trials as Topic MeSH
- Humans MeSH
- Colitis, Ulcerative drug therapy MeSH
- Ustekinumab * pharmacology therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
BACKGROUND: The increasing complexity of advanced endoscopic techniques places a high demand on the endoscopist's expertise. Thus, live porcine models have been more frequently used for training. We briefly describe a hands-on postgraduate endoscopic course regarding a novel method of treatment of anastomotic strictures in a porcine model. METHODS: The porcine model of Crohn's disease anastomotic stricture with two artificial side-to-side ileo-colonic anastomoses was used. Participants performed endoscopic stricturotomy under supervision at one of two equipped endoscopic stations. Available animals were endoscopically re-examined 3 months after the course. RESULTS: Twelve anastomoses were prepared for the course. Eleven circumferential stricturotomies together with horizontal cut and clip placement were conducted. All anastomoses were passable for the scope after the procedure, and no case of perforation or bleeding occurred. All anastomoses available for re-examination remained passable for the endoscope after 3 months. CONCLUSION: We successfully organised the first endoscopic hands-on course for the training of endoscopic stricturotomy on a large animal model.
- MeSH
- Crohn Disease * complications surgery MeSH
- Dilatation MeSH
- Humans MeSH
- Disease Models, Animal MeSH
- Swine MeSH
- Constriction, Pathologic etiology surgery MeSH
- Treatment Outcome MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND AND AIMS: Patients' perspectives after switching from originator to biosimilar adalimumab have yet to be assessed. We evaluated the efficacy of switching from the originator adalimumab to a biosimilar compound [SB5] in patients with inflammatory bowel disease [IBD]. METHODS: Data on IBD patients who were switched from the originator to biosimilar adalimumab [SB5] at IBD Center ISCARE were analysed. Disease activity was assessed using standard clinical indices (Harvey-Bradshaw index [HBI] for Crohn's disease [CD] and partial Mayo score for ulcerative colitis [UC]), and laboratory parameters (C-reactive protein [CRP] and faecal calprotectin [FC]). Trough levels and anti-drug antibodies were measured. Patients were evaluated 10 weeks [W10] after the switch, and results were compared with the control group of patients on originator compound. RESULTS: A total of 93 patients switched to biosimilar adalimumab were included [CD 86%] and were matched to 93 controls for age, gender, diagnosis, and disease activity. There was no difference in the disease activity in either SWITCH or ORIGINATOR cohorts between Weeks 0 and 10. Similarly, no difference was found between cohorts at both prespecified time points. Moreover, no significant differences in CRP or FC concentrations were seen between W0 and W10 either in the SWITCH, or in the ORIGINATOR cohort [p >0.05]. Adalimumab serum trough levels remained stable after the switch. No new safety signals were detected. CONCLUSIONS: Our study confirmed that switching IBD patients from the originator adalimumab to a biosimilar compound [SB5] does not affect treatment efficacy.
- MeSH
- Adalimumab blood immunology therapeutic use MeSH
- Biosimilar Pharmaceuticals blood therapeutic use MeSH
- C-Reactive Protein metabolism MeSH
- Tertiary Care Centers MeSH
- Crohn Disease blood drug therapy MeSH
- Adult MeSH
- Feces chemistry MeSH
- Gastrointestinal Agents blood immunology therapeutic use MeSH
- Leukocyte L1 Antigen Complex analysis MeSH
- Middle Aged MeSH
- Humans MeSH
- Drug Substitution MeSH
- Antibodies blood MeSH
- Retrospective Studies MeSH
- Severity of Illness Index MeSH
- Colitis, Ulcerative blood drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- MeSH
- Ileum pathology surgery MeSH
- Humans MeSH
- Proctocolectomy, Restorative adverse effects MeSH
- Aged MeSH
- Constriction, Pathologic surgery MeSH
- Check Tag
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Video-Audio Media MeSH
- Journal Article MeSH
- Case Reports MeSH
- Keywords
- vedolizumab,
- MeSH
- Feces microbiology MeSH
- Fecal Incontinence MeSH
- Suppuration MeSH
- Adrenal Cortex Hormones therapeutic use MeSH
- Antibodies, Monoclonal, Humanized therapeutic use MeSH
- Clinical Decision-Making * MeSH
- Comorbidity MeSH
- Humans MeSH
- Disease Progression MeSH
- Aged MeSH
- Colitis, Ulcerative * complications physiopathology therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Publication type
- Case Reports MeSH
