Endoscopic clips versus overstitch suturing system device for mucosotomy closure after peroral endoscopic pyloromyotomy (G-POEM): a prospective single-center study.

BACKGROUND AND AIMS: G-POEM is an emerging method for treatment of severe gastroparesis. Safe mucosal closure is necessary to avoid adverse events. The aim of this study was to compare the efficacy of two closure methods: clips and endoscopic suturing (ES) after G-POEM. METHODS: We performed a single center, prospective study. The closure method was assigned at the discretion of an endoscopist prior to the procedure. The main outcome was the proportion of subjects with successful closure. Unsuccessful closure was defined as a need for a rescue method, or a need for an additional intervention or incomplete closure-related adverse events. Secondary outcomes were the easiness of closure (VAS score 1 = very difficult, 10 = easy), closure time, and cost. RESULTS: A total of 40 patients [21 female; mean age, range 47.5; (20-74)] were included; 20 received ES and 20 clips [mean number of clips 6; range (4-19)]. All 20 patients with ES (100%, 95% CI 84-100%) and 18 patients with clips (89%, 95% CI 70-97%) had successful closure (p = 0.49). One patient needed a rescue method (KING closure) and the other patient an additional clipping on POD1. Closure with clips was quicker [mean time 9.8 (range 4-20) min vs. 14.1 (5-21) min; p = 0.007] and cheaper [mean cost 807 USD (± 402) vs. 2353 USD (± 145); p < 0.001]. Endoscopist assessed the easiness of ES and clips as comparable [mean VAS, range 7.5 (3-10) (ES) vs. 6.9 (3-10) (clips); p = 0.3]. CONCLUSIONS: Both ES and clips are effective methods for mucosal closure in patients undergoing G-POEM. However, centres using clips should have a rescue closure method available as clips may fail in some patients. Closure with ES is more costly than with clips.

Confocal laser endomicroscopy in diagnosing indeterminate biliary strictures and pancreatic lesions a prospective pilot study.

INTRODUCTION: An accurate histopathological diagnosis of indeterminate biliary strictures and pancreatic lesions is challenging because of insufficient quali-ty of tissue specimen taken during ERCP (brush cytology), cholangioscopy (biopsies) or endosonography (EUS, FNAB). Confocal laser endomicroscopy (CLE) allows virtual histopathological diagnosis with the potential to either replace or increase the diagnostic yield of standard histopathological diagnosis in patients presenting with biliary strictures and pancreatic lesions. The aims of our prospective pilot study were to: 1. Assess the diagnostic yield of standard histopathology compared to CLE in patients referred for cholangioscopy or for EUS of the pancreas; 2. Evaluate the cost of CLE in these indications. METHODS: CLE was performed (during cholangioscopy or EUS), followed by standard tissue sampling. CLE-based diagnosis was compared with standard histopathology/cytology. CLE probe was introduced through the working channel of the cholangioscope or through the FNAB needle. RESULTS: A total of 23 patients were enrolled (12 women, mean age 61 years); 13 patients underwent cholangioscopy and 10 patients underwent EUS. Cholangioscopy: CLE diagnosed correctly all 4 malignant strictures (histology 2 of them only as 2 patients had insufficient quality of the tissue specimen). Agreement between standard histopathology and CLE was achieved in 85 %. EUS: All 3 cases of pancreatic cancer were correctly diagnosed by both CLE and FNAB. All remaining (premalignant and benign) lesions were also correctly diagnosed by both methods. The cost of CLE examination is higher compared to FNAB but comparable with tissue sampling during digital cholangioscopy. CONCLUSION: CLE demonstrated sufficient diagnostic accuracy in patients with indeterminate biliary strictures or pancreatic lesions and, therefore, might improve diagnostic accuracy or even replace standard histopathology in these indications.

Per-oral endoscopic pyloromyotomy (g-poem) for the treatment of gastroparesis - a pilot single-centre study with mid-term follow-up.

INTRODUCTION: Endoscopic pyloromyotomy (G-POEM) is an emerging therapeutic method for the treatment of gastroparesis (GP). So far, only limited case-series suggesting its effectivity have been published. The aim of our study was to assess the effectivity of G-POEM in patients with refractory GP. METHODS: Consecutive patients with severe and refractory GP were offered the procedure. An abnormal gastric emptying study (GES) was necessary for inclusion. The main outcome was treatment success defined as a decrease of the total GSCI symptom score by at least 40% from baseline at 3, 6, 12 and 24 months. RESULTS: G-POEM was performed in 9 patients (5 women, mean age 56.3): 5 post-surgical, 2 diabetic, 1 idiopathic and 1 combined post-surgical and diabetic. The median follow-up was 23M (range 12-31). All procedures were successfully completed. One patient experienced delayed bleeding from gastric ulceration, which was successfully treated endoscopically; all remaining patients recovered uneventfully. Treatment success was achieved in 8/9 patients (88.9%) at 3, 6 and 12M and in 3/4 (75%) at 24M. The mean GSCI decreased from 3.16 to 0.86 (p=0.008), 0.74 (p=0.008), 1.07 (p=0.008) and 1.31 (p=0.11) at 3, 6, 12 and 24M after the procedure. The Quality of Life Index improved from the baseline value of 77 (range 48102) to 113 (86-138, p=0.03) and 96 (50-124, p=0.4) at 12 and 24M. In patients with treatment success, no recurrences have occurred so far. GES improved/normalized in all the patients. CONCLUSION: G-POEM was effective in 88.9% of patients with refractory GP and the effect seems to be long-lasting.

Fixation of biomaterial to metallic stent and fixation of stents after circular endoscopic dissection in the esophagus on an animal model.

INTRODUCTION: Complete circular endoscopic (submucosal) resection (CER) performed using the endoscopic submucosal dissection (ESD) technique is burdened with a high incidence of post-operative strictures in the esophagus. The most effective method of preventing them is not known so far; one of the possible methods is to prevent these strictures directly at the site of their formation by covering the defect with a stent. The aim of the study was to find a way to fix a selected biomaterial to a stent, and subsequently, to fix the stent at the CER site to prevent esophageal strictures in an animal model. METHOD: Miniature piglets from the Czech Academy of Sciences breeding unit in Libechov (N=10) were used. Endoscopy was performed using a single-channel endoscope. First, we made two circular mucosal cuts spaced 5 cm apart in the middle esophagus and we performed the CER between them using the endoscopic submucosal dissection technique. After that, we covered the defect with a stent coated with biomaterial (Xe-Derma®) while we tried to prevent stent migration into the stomach. For stent fixation, we tested endo-clips (N=3), the Apollo endoscopic system (N=1) and the suspension technique using two polyamide threads (N=6) anchored in the nasal septum. We performed a control endoscopy, stent removal and subsequent autopsy after 12 weeks. RESULTS: All procedures were completed successfully without serious complications or deaths. Although stents covered with Xe-Derma® were applied to the entire resection area, one case of mediastinitis and one paraesophageal abscess were found during autopsy, most likely due to microperforations caused during the procedure. Histological analysis showed that after contact with the biomaterial, re-epithelisation took place within one week of application to the resection area. Stent migration occurred in each case when the stent was attached to the esophageal wall by endo-clips or with the endoscopic suture system (Apollo). There was no stent dislocation in the cases where the stent was suspended by two polyamide threads. CONCLUSION: We developed a technique of fixing biomaterial to the surface of metallic stents which we used to prevent the formation of esophageal strictures after CER. Distal suspension fixation of the stent with a polyamide thread proved to be the most effective, while fixations by endo-clips or with the endoscopic suture system were ineffective.Key words: benign esophageal strictures circular endoscopic resection endoscopic submucosal dissection complication prevention.

Confocal laser endomicroscopy in the diagnostics of gastrointestinal lesions literary review and personal experience.

INTRODUCTION: Confocal laser endomicroscopy (CLE) is a new method enabling real-time histopathological diagnosis. Two platforms of CLE are used standardly: the so called probe-based CLE in which an endomicroscopic probe is inserted through an endoscope, and so-called needle-based CLE inserted through a needle. METHODS: CLE enables evaluation of epithelial and subepithelial structures with 1000x magnification in any part of the gastrointestinal system. The main advantage over conventional biopsies can be immediate diagnosis and larger area evaluated. CLE might play a promising role in indeterminate biliary lesions where biopsies are often not sufficient and fail to allow for accurate diagnosis. CLE can also have a promising potential in pancreatic lesions where it is used along with the needle designed for tissue aspiration during endosonography. It is also possible to use CLE in other organ systems and medical specialties, e.g. in pneumology, neurosurgery, ENT and others. CONCLUSION: CLE is a promising diagnostic method; however, it is unlikely to replace standard biopsies currently since these are still considered a gold standard of histopathological diagnosis. High purchase price is a main disadvantage of the method, hampering its expansion in medicine. Key words: confocal laser endomicroscopy CLE biliary strictures pancreatic lesions esophageal carcinoma Rozhl Chir 2018;97:531-538.