How to track and register adverse events and incidents related to gastrointestinal endoscopy.

Background and study aims: Gastrointestinal endoscopic procedures have evolved significantly in the last sixty years revolutionising the approach to the diagnostic and therapeutic spheres of medicine. Despite the advantages of using natural orifices to the bowel, adverse events (AE) may occur following endoscopy. Systematic AE registration is an objective in every realm of quality medicine. Despite the obvious advantage as a quality indicator, tracking endoscopy-related AE is not evident. The current study aimed at tracking all AE of all endoscopic procedures during a 3-month period. The three methods used were voluntary reporting by the endoscopist and by the patient in parallel with retrospective data analysis of patients' electronic medical records to allow capture of all AE and comparison of the three methods. Patients and methods: During a 3-month period endoscopists and patients were requested to report any possible AE. At the end of the period, a systematic review of all patient files was performed to track all AE related to the endoscopic procedure or the endoscopyrelated anaesthesia. In total 2668 endoscopic procedures were reviewed. Results: The total AE rate was 1.95%. Only half (51.9%) of all AE were voluntarily reported by endoscopists, the other half were extracted from the electronic medical record. There were no patient-reported AE. Although the majority (66.7%) of unreported AE were mild, these findings illustrate that voluntary AE reporting is unreliable. However, the retrospective tracking process proved to be difficult and time-consuming. Conclusions: The current study highlighted that systematic registration of all endoscopy-related AE is feasible, but challenging because of multiple hurdles. More practical methods are warranted to obtain reliable and long-term data as part of endoscopy quality measures.

The Belgian national registry on chronic pancreatitis: A prospective multi-centre study covering more than 800 patients in one year.

BACKGROUND/OBJECTIVES: The epidemiology, natural history, complications, and therapeutic management of chronic pancreatitis (CP) are not well described at the national level. This multi-centre prospective observational study involving eight Belgian hospitals aimed to improve the understanding of these aspects of CP in Belgium. METHODS: All patients with a diagnosis of CP based on imaging were eligible for this study. Data were gathered regarding epidemiology, etiology, CP complications, and treatment modalities. RESULTS: A total of 809 patients were included between 1/9/2014 and 31/8/2015. Most patients (794) were adults ≥16-years old, 74% were male, the median age at symptom onset was 47 (38-57) years, the median disease duration was 7 (3-13) years, and the median Izbicki pain score (IPS) was 96 (0-195). The main etiological risk factors according to the TIGAR-O classification were alcohol and tobacco (67%). Current drinkers had lower body mass index (BMI) (21.4 kg/m2 vs 24.1 kg/m2), higher IPS (110 vs 56), and longer inability to work than non-drinkers. Current smokers had lower BMI (21.5 kg/m2 vs 25 kg/m2) and higher IPS (120 vs 30) than non-smokers. Endocrine insufficiency and/or clinical steatorrhea was recorded in 41% and 36% of patients, respectively. The highest IPS was reported in patients with ongoing endotherapy (166 vs 50 for patients who completed endoscopy). CONCLUSION: This multicentric study on CP patients showed that current alcohol drinking and smoking are associated with pain and malnutrition. Pain scores were higher in patients with ongoing endotherapy, independently of surgery.

Comparison of side-viewing duodenoscope and single-balloon enteroscope to perform ERCP in patients with Billroth II gastrectomy.

Endoscopic retrograde cholangiopancreatography (ERCP) in Billroth II patients is challenging and different endoscopes can be used. We retrospectively analysed 67 ERCP procedures in 38 Billroth II patients focussing on endoscope type and respective technical success and adverse event rate. 33 (49.2 %) ERCPs were performed using a duodenoscope, 87.9 % were successful and 3 were completed with the single-balloon enteroscope. 28 (41.8 %) ERCPs were performed with the single-balloon enteroscope, 82.1 % were successful and 2 were completed with a paediatric colonoscope. For 6 (9.0 %) ERCPs a paediatric colonoscope was used but only 3 (50.0 %) were successful. Overall technical success rate was 82.1 % without difference between the success rate of the duodenoscope and the single-balloon enteroscope. Overall adverse event rate was 10.5 %: 6.1 % duodenoscope,10.7 % single-balloon enteroscope, 33.3 % paediatric colonoscope. The duodenoscope allowed all conventional ERCP procedures, whereas the singleballoon enteroscope required dedicated ERCP catheters and did not allow metallic stent placement. However, the single-balloon enteroscope facilitated access to the papilla and sphincteroplasty allowed direct cholangioscopy. ERCP indications were bile duct stones (53.7 %), cholangitis (20.9 %), chronic pancreatitis (20.9 %), pancreatic cancer (1.5 %) and liver transplantation (3%). Therapeutic ERCP success rate is high in patients with Billroth II gastrectomy using either a conventional duodenoscope or the single-balloon enteroscope, with an acceptable and comparable adverse event rate. The choice of endoscope may depend on local experience, post-operative anatomy and therapeutic indication.

Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system 1 2 was adopted to define the strength of recommendations and the quality of evidence. Main Recommendations: 1 ESGE recommends endoscopic en bloc resection for superficial esophageal squamous cell cancers (SCCs), excluding those with obvious submucosal involvement (strong recommendation, moderate quality evidence). Endoscopic mucosal resection (EMR) may be considered in such lesions when they are smaller than 10 mm if en bloc resection can be assured. However, ESGE recommends endoscopic submucosal dissection (ESD) as the first option, mainly to provide an en bloc resection with accurate pathology staging and to avoid missing important histological features (strong recommendation, moderate quality evidence). 2 ESGE recommends endoscopic resection with a curative intent for visible lesions in Barrett's esophagus (strong recommendation, moderate quality evidence). ESD has not been shown to be superior to EMR for excision of mucosal cancer, and for that reason EMR should be preferred. ESD may be considered in selected cases, such as lesions larger than 15 mm, poorly lifting tumors, and lesions at risk for submucosal invasion (strong recommendation, moderate quality evidence). 3 ESGE recommends endoscopic resection for the treatment of gastric superficial neoplastic lesions that possess a very low risk of lymph node metastasis (strong recommendation, high quality evidence). EMR is an acceptable option for lesions smaller than 10 - 15 mm with a very low probability of advanced histology (Paris 0-IIa). However, ESGE recommends ESD as treatment of choice for most gastric superficial neoplastic lesions (strong recommendation, moderate quality evidence). 4 ESGE states that the majority of colonic and rectal superficial lesions can be effectively removed in a curative way by standard polypectomy and/or by EMR (strong recommendation, moderate quality evidence). ESD can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion that is based on two main criteria of depressed morphology and irregular or nongranular surface pattern, particularly if the lesions are larger than 20 mm; or ESD can be considered for colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques (strong recommendation, moderate quality evidence).(AU)

Established EUS-guided therapeutic interventions.

Over the three last decades, endosonography ultrasound (EUS) has evolved from a diagnostic tool to an interventional modality through cumulative advances in experience, knowledge, equipment, and devices. EUS-guided therapeutic procedures appear feasible and safe when performed in highly-experienced centers. This review covers the technical aspects, indications, and results of the most commonly performed procedures. Celiac plexus neurolysis and collection drainages are now well-established techniques and considered to be first-line treatments. Biliary and pancreatic EUS-guided drainages are, conversely, more challenging, and there is currently insufficient clinical evidence documenting their superiority over established practice. Well-designed prospective trials are thus needed in order to accurately assess this modality's risks and long-term outcomes compared to radiological or surgical techniques.

Pancreatic neuroendocrine tumour grading on endoscopic ultrasound-guided fine needle aspiration: high reproducibility and inter-observer agreement of the Ki-67 labelling index.

OBJECTIVES: Assessment of proliferation by the Ki-67 labelling index (Ki67-LI) is an important parameter of pancreatic neuroendocrine tumour (pNET) prognosis on resection specimens. Ki67-LI values for grading are not fully established on endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The aim of the study was to determine the accuracy of Ki67-LI on EUS-FNA to predict a final grade of pNET and to analyse the relationship between cytological grading and progression-free survival (PFS). METHODS: Between 1996 and 2010, 46 pNETs (33 were resected) from 45 patients were diagnosed by EUS-FNA. Ki67-LI was evaluated on cytological and histological material for each tumour and classified according to the 2010 WHO grading system. RESULTS: A very good inter-observer agreement for Ki67-LI on EUS-FNA and surgical specimens, respectively, were obtained. Discrepancies were observed between histology and cytology, especially in grade 2 (G2) tumours, where cytology underestimated grading owing to tumour heterogeneity. Still, EUS-FNA was able to distinguish a poor prognostic group, as the actuarial PFS of cytological (c) G3 tumours was 10 ± 4 months versus 29 ± 7 and 68 ± 10 for cG2 and cG1 tumours, respectively (P < 0.0001). CONCLUSION: This study attests the reproducibility of Ki67-LI of pNETs whether counted on cytology or histology with a very good inter-observer correlation. Determination of Ki67-LI on EUS-FNA of pNETs should be included systematically in their prognostic work-up.

Seeding of the percutaneous endoscopic gastrostomy site from head and neck carcinoma: case report and review of the literature.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is a relatively safe procedure and is an important supportive treatment for patients with advanced head and neck cancer. Although tumor seeding has been reported in various sites, seeding at the PEG exit site is a rare complication. METHODS AND RESULTS: We describe a clinical case in which squamous cell carcinoma of the hypopharynx implanted at the site of PEG insertion and was successfully removed by surgery. PEG was previously placed by the "pull" technique. A review of the literature, discussion of the mechanism of spread, and recommendations to avoid this complication are discussed. CONCLUSIONS: To avoid this rare and poor prognostic complication, the "pull" technique should be avoided for PEG placement in any patient with head and neck squamous cell carcinoma. An alternative method such as the "push" technique should be preferred.

Optimizing specimen collection and laboratory procedures reduces the non-diagnostic rate for endoscopic ultrasound-guided fine-needle aspiration of solid lesions of the pancreas.

OBJECTIVES: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a routine technique to assess solid pancreatic lesions. The aim of this study was to analyse the effect of optimizing laboratory procedures for specimen preparation on the rate and accuracy of the procedure. METHODS: All EUS-FNAs of solid pancreatic lesions performed during the year 2000 (Period 1) and from May 2003 to May 2004 (Period 2) were analysed. During Period 1, one experienced gastroenterologist performed all EUS-FNAs, making direct smears and retrieving small fragments if present on the smear for histology. In Period 2, two endoscopists performed the EUS-FNAs and all the material was emptied into a vial containing a fixative. Slide preparation was carried out in the pathology laboratory: one slide was processed using cytocentrifugation and cell blocks were made from left-over material. Neither period utilized rapid on-site evaluation. RESULTS: During the two periods, 67 and 102 FNAs were analysed and showed significantly different (P < 0.001) non-diagnostic rates of 22.8% and 4.2%, respectively. The increased diagnostic yield can be explained by the modified laboratory procedures and to a lesser extent by the increased experience of the gastroenterologists. Sensitivity, specificity, PPV, NPV and accuracy in the second time period were, respectively, 90.6%, 100%, 100%, 81.8% and 93.4%, not significantly different from the first time period. CONCLUSION: This study shows that accurate EUS-FNA results may be obtained with a low non-diagnostic rate comparable to those reported for rapid on-site evaluation by optimizing laboratory specimen processing in a setting of solid pancreatic lesions.

Endoscopic diagnosis and treatment of upper gastrointestinal tumors.

Early diagnosis, endoscopic differentiation of benign from malignant lesions, and removal of clinically significant tumors are increasingly considered to be major topics of interest in the upper gastrointestinal tract. This interest is mainly due to the development of better imaging tools and new resection techniques that fulfill surgical criteria. At this year's Digestive Disease Week (DDW; 7-10 May 2011, Chicago, Illinois, USA), more than 500 abstracts were presented that focused on better imaging, training, safety issues, luminal stenting, and indications and results in endoscopic submucosal dissection (ESD). This review highlights a selection of clinically relevant reports of the upper gastrointestinal tract, excluding Barrett's esophagus, which is covered in a separate report. Related abstracts that are not discussed in this review can be found in the additional references of interest.

Endoscopic ultrasound-guided transluminal drainage of pancreatic duct obstruction: long-term outcome.

BACKGROUND AND STUDY AIMS: Endoscopic ultrasound-guided pancreatic drainage (EUS-PD) has been reported as an alternative to surgery, when transpapillary access to the main pancreatic duct (MPD) is impossible. The aim of the study was to investigate the feasibility of the procedure and long-term clinical outcome in patients treated with EUS-PD. PATIENTS AND METHODS: We retrospectively analyzed our single-center experience over a 10-year period. RESULTS: EUS-PD was attempted in 20 patients (24 interventions), with a median age of 64 years (range 36 - 78). Indications for the procedure were post-Whipple symptomatic anastomotic stricture (n = 10) and chronic pancreatitis (n = 10). EUS-PD was performed by a transgastric (n = 16) or transbulbar (n = 3) route or with a rendezvous technique (n = 5). Wirsungography was performed in all interventions and successful drainage was achieved in 18 / 20 (90 %) patients. There were two minor procedure-related complications: bleeding that was treated endoscopically, and a perigastric collection that resolved spontaneously. Median follow up was 37 months (range 3 - 120 months), stent dysfunction occurred in 9 / 18 (50 %) patients. Out of 18 patients with successful EUS-PD, long-term pain resolution was observed in 13 (72 %). At the last follow-up visit, there were significant decreases in pain scores, from 7.5 to 1.6, and in MPD size from 8.1 mm to 3.9 mm. Failure was associated with cancer presence or recurrence. CONCLUSIONS: Technical success rate of EUS-PD and clinical long-term pain resolution were 90 % and 72 %, respectively. EUS-PD is a reliable procedure with a low complication rate. It might therefore replace surgery at expert centers.

Current practice with endoscopic submucosal dissection in Europe: position statement from a panel of experts.

Endoscopic submucosal dissection (ESD) is the gold standard technique for performing en bloc resection of large superficial tumors in the upper and lower gastrointestinal tract. Experience in Europe, however, is still limited and ESD is only performed in a few selected centers, with low volumes of cases, no description of training programs, and few published reports. In 2008, a panel of experts gathered in Rotterdam to discuss indications, training, and the wider use of ESD. The panel of experts and participants reached a consensus on five general statements: 1) ESD aims at treating mucosal cancer; 2) treatment aims for R0 resection; 3) ESD should meet quality standards; 4) ESD should be performed following national or European Society of Gastrointestinal Endoscopy (ESGE) guidelines or under institutional review board approval; and 5) ESD cases should be registered. Due to the high level of expertise needed to perform the technique safely, ESD should be performed in a step-up approach, starting with lesions presenting in the rectum or in the distal stomach, then colon, proximal stomach, and finally in the esophagus. Registration is advised either at the local site or at a national or ESGE level, and should include information on indication (Paris classification of lesion, location, and histological results prior to treatment), technique used (e. g. type of knife), results (en bloc and R0 resection), complications, and follow-up. The panel also agreed on minimal institutional requirements: good quality imaging, experienced histopathologist following the Japanese criteria (2-mm sections, micrometric invasion, vessel and lymphatic infiltration, etc), and dedicated endoscopic follow-up. Moreover, minimum training requirements were also defined: knowledge in indications and instruments, exposure to experts (currently all in Japan), hands-on experience in a model of isolated pig stomach and in live pigs, and management of complications. The experts did not reach a consensus on a minimum case load, or whether the technique should be restricted to expert centers.

Stepwise radical endoscopic resection for Barrett's esophagus with early neoplasia: report on a Brussels' cohort.

BACKGROUND AND STUDY AIMS: The aim of this retrospective study was to assess safety and efficacy of stepwise radical endoscopic resection (SRER) in patients with Barrett's esophagus with high-grade intraepithelial neoplasia (HGIN) or early cancer. PATIENTS AND METHODS: Patients undergoing SRER between 2000 and 2006 were retrospectively evaluated. Patients with Barrett's esophagus who also had HGIN or early cancer were included if they had no signs of submucosal infiltration or metastases. SRER was performed using the cap-technique, at 8-week intervals until all Barrett's esophagus was removed. Follow-up endoscopy was scheduled every 6 months. RESULTS: A total of 34 patients were included (31 male, mean 67 years, median Barrett's dimensions C1M4). HGIN / early cancer was eradicated in all patients in a median of two endoscopic resection sessions (IQR 1-2 sessions). Twelve patients underwent additional argon plasma coagulation for small islets or an irregular Z-line. Barrett's esophagus was eradicated in 28 patients (82 %). Complications occurred in 3/34 patients (9 %): two perforations, one delayed bleeding. In all, 19 patients (56 %) developed dysphagia, which was resolved with dilatation or stent placement. During a median follow-up period of 23 months (IQR 15 - 41 months), HGIN / early cancer recurred in three patients (9 %): two were retreated with endoscopic resection and one patient was referred for curative surgery. Five patients (15 %) had recurrence of nondysplastic Barrett's esophagus. At the end of the follow-up period all patients were free of HGIN / early cancer (one patient after surgery), and 23 patients (68 %) had complete endoscopic and histological eradication of Barrett's esophagus. CONCLUSIONS: SRER resulted in complete eradication of HGIN/early cancer in all patients, and eradication of Barrett's esophagus in a majority of cases. A significant number of patients develop dysphagia, which can be successfully treated endoscopically.