How to implement adverse events as a quality indicator in gastrointestinal endoscopy.

Quality improvement through the registration of endoscopy-related adverse events (AEs) has been recognized by major international endoscopy societies as an important quality indicator. The theory behind this is easier to approve than its implementation in daily practice. The results of many valuable attempts have been published in the literature, mainly highlighting the diverse hurdles trying to capture events related to endoscopy and the sedation used for endoscopic procedures. The current review discusses the difficulties encountered attempting to register AEs and incidents related to endoscopic procedures. Government-driven and financed health-care databases with automated coupling of specific data seem the only efficient way to implement endoscopy-related AEs and outcomes on a prospective and complete basis. This will not only allow continuous confidential feedback to endoscopists in relation to the pooled national benchmark data, but also follow-up in time through data-driven credentialing aiming to progressively optimize these benchmark data.

Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stents: a retrospective multicentric comparison of wireless and over-the-wire techniques.

BACKGROUND: Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) using lumen-apposing metal stents (LAMSs) appears to be effective and safe in gastric outlet obstruction (GOO); however, the EUS-GE procedure is not standardized, with the use of assisted or direct methods still debated. The aim of this study was to compare the outcomes of EUS-GE techniques focusing on an assisted with orointestinal drain wireless endoscopic simplified technique (WEST) and the nonassisted direct technique over a guidewire (DTOG). METHOD: This was a multicenter European retrospective study involving four tertiary centers. Consecutive patients who underwent EUS-GE for GOO between August 2017 and May 2022 were included. The primary aim was to compare the technical success and adverse event (AE) rates of the different EUS-GE techniques. Clinical success was also analyzed. RESULTS: 71 patients (mean [SD] age 66.2 10 years; 42.3 % men; 80.3 % malignant etiology) were included. Technical success was higher in the WEST group (95.1 % vs. 73.3 %; estimate of relative risk from odds ratio (eRR) 3.2, 95 %CI 0.94-10.9; P = 0.01). The rate of AEs was lower in the WEST group (14.6 % vs. 46.7 %; eRR 2.3, 95 %CI 1.2-4.5; P = 0.007). Clinical success was comparable between the two groups at 1 month (97.5 % vs. 89.3 %). The median follow-up was 5 months (range 1-57). CONCLUSION: The WEST resulted in a higher technical success rate with fewer AEs, with clinical success comparable with the DTOG. Therefore, the WEST (with an orointestinal drain) should be preferred when performing EUS-GE.

Endoscopic treatment of biliopancreatic pathology in patients with Whipple's pancreaticoduodenectomy surgical variants: Lessons learned from single-balloon enteroscopy-assisted ERCP.

BACKGROUND: Endoscopic treatment of biliopancreatic pathology is challenging due to surgically altered anatomy after Whipple's pancreaticoduodenectomy. This study aimed to evaluate the feasibility and safety of single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (SBE-ERCP) to treat biliopancreatic pathology in patients with Whipple's pancreaticoduodenectomy surgical variants. METHODS: We retrospectively analyzed 106 SBE-ERCP procedures in 46 patients with Whipple's variants. Technical and clinical success rates and adverse events were evaluated. RESULTS: Biliary SBE-ERCP was performed in 34 patients and pancreatic SBE-ERCP in 17, including 5 with both indications. From a total of 106 SBE-ERCP procedures, 76 were biliary indication with technical success rate of 68/76 (90%) procedures and clinical success rate of 30/34 (88%) patients. Mild adverse event rate was 8/76 (11%), without serious adverse events. From a total of 106 SBE-ERCP procedures, 30 were pancreatic indication with technical success rate of 24/30 (80%) procedures (P = 0.194 vs. biliary SBE-ERCP) and clinical success rate of 11/17 (65%) patients (P = 0.016 vs. biliary SBE-ERCP). Mild adverse event rate was 6/30 (20%) (P = 0.194 vs. biliary SBE-ERCP), without serious adverse events. After SBE-ERCP failure, endoscopic ultrasound-guided drainage, percutaneous drainage and redo surgery were alternative therapeutic options. CONCLUSIONS: Biliopancreatic pathology after Whipple's pancreaticoduodenectomy variants can be treated using SBE-ERCP without serious adverse events. Technical and clinical success rates are high for biliary indications, whereas clinical success rate of pancreatic indications is significantly lower. SBE-ERCP can be considered as first-line treatment option in this patient group with surgically altered anatomy.

PERcutaneous transhepatic CHOLangioscopy using a new single-operator short cholangioscope (PERCHOL): European feasibility study.

OBJECTIVES: A new short device for percutaneous endoscopic cholangioscopy was recently developed. However, feasibility and safety has not yet been evaluated. The aim of this study was to assess clinical success, technical success, and adverse events (AEs). METHODS: This observational multicenter retrospective study included all patients who underwent percutaneous cholangioscopy using a short cholangioscope between 2020 and 2022. The clinical success, defined as the complete duct clearance or obtaining at least one cholangioscopy-guided biopsy, was assessed. The histopathological accuracy, technical success, and the AE rate were also evaluated. RESULTS: Fifty-one patients (60 ± 15 years, 45.1% male) were included. The majority of patients had altered anatomy (n = 40, 78.4%), and biliary stones (n = 34, 66.7%) was the commonest indication. The technique was predominantly wire-guided (n = 44, 86.3%) through a percutaneous sheath (n = 36, 70.6%) following a median interval of 8.5 days from percutaneous drainage. Cholangioscopy-guided electrohydraulic lithotripsy was performed in 29 cases (56.9%), combined with a retrieval basket in eight cases (27.6%). The clinical success was 96.6%, requiring a median of one session (range 1-3). Seventeen patients (33.3%) underwent cholangioscopy-guided biopsies. There were four (7.8%) cholangioscopy-related AEs (cholangitis and peritonitis). Overall, the technical success and AE rates were 100% and 19.6%, respectively, in a median follow-up of 7 months. CONCLUSION: Percutaneous endoscopic cholangioscopy with a new short device is effective and safe, requiring a low number of sessions to achieve duct clearance or accurate histopathological diagnosis.

Endoscopic management of subepithelial lesions including neuroendocrine neoplasms: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

1: ESGE recommends endoscopic ultrasonography (EUS) as the best tool to characterize subepithelial lesion (SEL) features (size, location, originating layer, echogenicity, shape), but EUS alone is not able to distinguish among all types of SEL.Strong recommendation, moderate quality evidence. 2: ESGE suggests providing tissue diagnosis for all SELs with features suggestive of gastrointestinal stromal tumor (GIST) if they are of size > 20 mm, or have high risk stigmata, or require surgical resection or oncological treatment.Weak recommendation, very low quality evidence. 3: ESGE recommends EUS-guided fine-needle biopsy (EUS-FNB) or mucosal incision-assisted biopsy (MIAB) equally for tissue diagnosis of SELs ≥ 20 mm in size.Strong recommendation, moderate quality evidence. 4: ESGE recommends against surveillance of asymptomatic gastrointestinal (GI) tract leiomyomas, lipomas, heterotopic pancreas, granular cell tumors, schwannomas, and glomus tumors, if the diagnosis is clear.Strong recommendation, moderate quality evidence. 5: ESGE suggests surveillance of asymptomatic esophageal and gastric SELs without definite diagnosis, with esophagogastroduodenoscopy (EGD) at 3-6 months, and then at 2-3-year intervals for lesions < 10 mm in size, and at 1-2-year intervals for lesions 10-20 mm in size. For asymptomatic SELs > 20 mm in size that are not resected, ESGE suggests surveillance with EGD plus EUS at 6 months and then at 6-12-month intervals.Weak recommendation, very low quality evidence. 6: ESGE recommends endoscopic resection for type 1 gastric neuroendocrine neoplasms (g-NENs) if they grow larger than 10 mm. The choice of resection technique should depend on size, depth of invasion, and location in the stomach.Strong recommendation, low quality evidence. 7: ESGE suggests considering removal of histologically proven gastric GISTs smaller than 20 mm as an alternative to surveillance. The decision to resect should be discussed in a multidisciplinary meeting. The choice of technique should depend on size, location, and local expertise.Weak recommendation, very low quality evidence. 8: ESGE suggests that, to avoid unnecessary follow-up, endoscopic resection is an option for gastric SELs smaller than 20 mm and of unknown histology after failure of attempts to obtain diagnosis.Weak recommendation, very low quality evidence. 9: ESGE recommends basing the surveillance strategy on the type and completeness of resection. After curative resection of benign SELs no follow-up is advised, except for type 1 gastric NEN for which surveillance at 1-2 years is advised.Strong recommendation, low quality evidence. 10: For lower or upper GI NEN with a positive or indeterminate margin at resection, ESGE recommends repeating endoscopy at 3-6 months and another attempt at endoscopic resection in the case of residual disease.Strong recommendation, low quality evidence.

Risk factors of refractory post-endoscopic submucosal dissection esophageal strictures.

INTRODUCTION: our aim was to comparatively assess the treatment outcomes of endoscopic dilatation in Barrett's neoplasia and squamous cell carcinoma (SCC) post-endoscopic submucosal dissection (ESD) strictures, and to determine the risk or factors associated to refractory strictures. METHODS: an observational study. All consecutive patients presenting with a post-ESD stricture in 2007-2016 who underwent dilation therapy were included. Clinical, morphological, and technical features were assessed to determine the risk factors of refractory strictures. RESULTS: of 414 consecutive patients treated by ESD, 83 (mean age: 65 ± 10 years, 76 % men) with 254 dilations (median: 3, range: 1-27) were considered. Barrett's neoplasia and SCC were the indications in 58 (69.9 %) and in 25 (30.1 %) cases, respectively. Clinical success was achieved in 84.3 % with a median of 3 sessions (range: 1-22), with a higher rate in Barrett's neoplasia (89.7 % vs. 72 %, p = 0.042). Circumferential resection in one single procedure (13.2 %) was associated with the need for a higher number of dilation sessions. By multivariate analysis, upper-esophageal location (OR: 11.479 [95 % CI: 2.058-64.043], p = 0.005), recurrent strictures (OR: 17.252 [95 % CI: 2.833-105.069], p = 0.002), and dilation-related complications (OR: 26.420 [95 % CI: 1.736-401.966], p = 0.018) were risk factors of refractory stenosis. CONCLUSION: patients presenting with SCC located in the upper superior esophagus, intra-procedural perforation, and recurrent strictures are at higher risk of developing refractory strictures.

A new 12-French plastic stent for unresectable distal malignant biliary obstruction.

BACKGROUND: Self-expanding metal stents (SEMSs) are recommended in unresectable distal malignant biliary obstruction. However, problems with dysfunction and migration of these stents are not negligible. We aimed to investigate the effectiveness and safety of a new 12-Fr plastic stent. METHODS: In an observational, prospective study, all consecutive patients who underwent biliary stenting with the 12-Fr stent were considered (index group). Referent groups were a historical cohort, matched by sex, etiology, and metastatic status, including patients with 10-Fr plastic stents and with fully covered and uncovered SEMSs (FCSEMSs and UCSEMSs). Outcomes were stent patency, recurrent biliary obstruction (RBO), technical success, 30-day mortality and adverse events. A post-procedure examination of removed stents was done. RESULTS: 72 patients (median age 66, range 32 - 94 years, 50 % men) were included (24 index, 48 referents). There were no differences in median stent patency time (P = 0.684). RBO was significantly lower with the 12-Fr compared with the 10-Fr profile stent (50 % vs. 81.3 %, P = 0.04), but no difference was found compared with the FCSEMSs (50 % vs. 43.8 %, P = 0.698). Technical success was 100 %, with no differences in 30-day mortality P = 0.105). The adverse events rate was 4.2 % for both groups (index n = 1, referents n = 2). Of 11 removed 12-Fr plastic stents suspected to be dysfunctional, 7 (64 %) were still patent. CONCLUSIONS: This new 12-Fr plastic stent could be an effective and cheaper alternative to SEMSs in distal malignant biliary obstruction.

A comprehensive systematic review and meta-analysis of risk factors for rebleeding following device-assisted enteroscopy therapy of small-bowel vascular lesions.

INTRODUCTION: the aim of this study was to determine the risk factors for rebleeding following device-assisted enteroscopy therapy of small bowel vascular lesions. METHODS: this is a systematic review and meta-analysis. A literature search was performed from January 2003 to October 2019. All studies reporting on at least one risk factor for bleeding recurrence after endoscopic therapy of small bowel vascular lesions were included. A meta-analysis of those risk factors reported in at least three studies was performed to assess their association with rebleeding. The OR and 95 % CI were used for binary outcome data. Heterogeneity analysis was performed using the Tau and I2 index. If I2 > 20 %, potential sources of heterogeneity were identified by sensitivity analyses and a random-effect model was used. RESULTS: the search identified a total of 572 articles and 35 full-text records were assessed for eligibility after screening. Finally, eight studies that included 548 patients were selected. The overall median rebleeding rate was 38.5 % (range: 10.9-53.3 %) with a median follow-up of 24.5 months. Female sex (OR: 1.96, 95 % CI: 1.14-3.37, p = 0.01, I2 = 0 %), Osler-Weber syndrome (OR: 4.35, 95 % CI: 1.22-15.45, p = 0.02, I2 = 0 %) and cardiac disease (OR: 1.89, 95 % CI: 1.12-2.97, p = 0.005, I2: 0 %) were associated with rebleeding. According to the sensitivity analysis, overt bleeding (OR: 2.13, 95 % CI: 1.22-3.70, p = 0.007, I2 = 0 %), multiple lesions (OR: 4.57, 95 % CI: 2.04-10.22, p < 0.001, I2 = 0 %) and liver cirrhosis (OR: 2.61, 95 % CI: 1.11-6.13, p = 0.03, I2 = 0 %) were also predictors for rebleeding. CONCLUSIONS: patient characteristics and comorbidities should be considered for follow-up patient management after effective device-assisted endoscopic therapy, as they can predict rebleeding.

Risk factors for conversion to snare resection during colorectal endoscopic submucosal dissection in an expert Western center.

BACKGROUND: There are limited data regarding the risk factors and consequences of conversion to endoscopic mucosal resection (rescue EMR) during colorectal endoscopic submucosal dissection (ESD) in Western centers. METHODS: This was a retrospective analysis of a prospectively collected database, from which 225 consecutive ESDs performed between 2013 and 2017 were selected. Of the included patients, 39 (18.6 %) required rescue EMR. Pre- and per-procedure characteristics were evaluated to determine the features associated with the need for rescue EMR. Outcomes and complications were also assessed. RESULTS: 210 patients were included, with median tumor size of 40 mm (range 20 - 110) and most tumors being in a non-rectal location (66.2 %). When compared with full ESD, rescue EMR was significantly associated with lower rates of en bloc resection (43.6 % vs. 100 %) and complete resection (R0 status; 28.2 % vs. 88.9 %), and with a higher rate of recurrence (5.1 % vs. 0 %) and more need for surgery (15.4 % vs. 3.5 %). In multivariable analysis, non-lifting (adjusted odds ratio [ORa] 3.06, 95 % confidence interval [CI] 1.23 - 7.66; P = 0.02), nongranular-type laterally spreading tumor (LST-NG; ORa 2.56, 95 %CI 1.10 - 5.99; P = 0.03), and difficult retroflexion (OR 3.22, 95 %CI 1.01 - 10.28; P = 0.049) were independent risk factors associated with conversion to rescue EMR, while tumor size and location were not. CONCLUSIONS: During ESD, the presence of poor lifting, LST-NG morphology, and a difficult retroflexed approach were factors associated with the need to convert to rescue EMR. Conversion to rescue EMR remains a valuable strategy.

Update in enteroscopy: New devices and new indications.

The present review provides an update of the currently available (proto-) types of device-assisted enteroscopy (DAE). In recent years, newly designed double- and single-balloon enteroscopes have emerged. They aim to improve insertion depth into the small bowel, and they also allow more efficient endoscopic interventions. Nowadays, almost all conventional endoscopic procedures are feasible using DAE, opening the door to new indications. Recently, more data have become available on pediatric DAE, DAE-assisted colonoscopy, and DAE in patients with altered anatomy, including DAE-assisted endoscopic retrograde cholangiopancreatography and direct cholangioscopy. Although new enteroscopes are being developed, few comparative studies are available in order to define which DAE suits best for each indication. It is the duty of the international endoscopy community to set up clinical research projects to provide answers to these open questions.

Techniques for endoscopic retrograde cholangiopancreatography in altered gastrointestinal anatomy.

PURPOSE OF REVIEW: This review highlights the current status of endoscopic retrograde cholangiopancreatography (ERCP) techniques in patients with altered anatomy. Endoscopic treatment of biliopancreatic disorders is particularly challenging in patients with altered anatomy. RECENT FINDINGS: There are two main approaches to perform ERCP in patients with altered anatomy: the transluminal access and the transmural access. The transluminal access uses device-assisted enteroscopy (DAE) to reach and cannulate the biliopancreatic system. The transmural access is created using therapeutic endoscopic ultrasound (EUS) or surgery to reach the biliopancreatic system. Both techniques are under continuous development and optimization. SUMMARY: Based on the currently available data in the literature, the transluminal access is the preferred first-line approach because of an acceptable success rate and an excellent safety profile, whereas the transmural approach may be more efficacious but with a higher complication rate, even in experienced hands. Due to the complexity of both techniques and the relative low number of procedures, patients with altered anatomy are best referred to high-volume centres where both techniques are available for optimal treatment.

An international multicenter study comparing EUS-guided pancreatic duct drainage with enteroscopy-assisted endoscopic retrograde pancreatography after Whipple surgery.

BACKGROUND AND AIMS: Endoscopic management of post-Whipple pancreatic adverse events (AEs) with enteroscopy-assisted endoscopic retrograde pancreatography (e-ERP) is associated with high failure rates. EUS-guided pancreatic duct drainage (EUS-PDD) has shown promising results; however, no comparative data have been done for these 2 modalities. The goal of this study is to compare EUS-PDD with e-ERP in terms of technical success (PDD through dilation/stent), clinical success (improvement/resolution of pancreatic-type symptoms), and AE rates in patients with post-Whipple anatomy. METHODS: This is an international multicenter comparative retrospective study at 7 tertiary centers (2 United States, 2 European, 2 Asian, and 1 South American). All consecutive patients who underwent EUS-PDD or e-ERP between January 2010 and August 2015 were included. RESULTS: In total, 66 patients (mean age, 57 years; 48% women) and 75 procedures were identified with 40 in EUS-PDD and 35 in e-ERP. Technical success was achieved in 92.5% of procedures in the EUS-PDD group compared with 20% of procedures in the e-ERP group (OR, 49.3; P < .001). Clinical success (per patient) was attained in 87.5% of procedures in the EUS-PDD group compared with 23.1% in the e-ERP group (OR, 23.3; P < .001). AEs occurred more commonly in the EUS-PDD group (35% vs 2.9%, P < .001). However, all AEs were rated as mild or moderate. Procedure time and length of stay were not significantly different between the 2 groups. CONCLUSIONS: EUS-PDD is superior to e-ERP in post-Whipple anatomy in terms of efficacy with acceptable safety. As such, EUS-PDD should be considered as a potential first-line treatment in post-pancreaticoduodenectomy anatomy when necessary expertise is available.

Comparison of double-balloon and single-balloon enteroscope for therapeutic endoscopic retrograde cholangiography after Roux-en-Y small bowel surgery.

BACKGROUND: Roux-en-Y reconstructive surgery excludes the biliopancreatic system from conventional endoscopic access. Balloon-assisted enteroscopy allows therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in these patients, avoiding rescue surgery. The objective of the current study is to compare success and complication rate of double-balloon (DBE) and single-balloon enteroscope (SBE) to perform ERCP in Roux-en-Y patients. METHODS: Seventy three Roux-en-Y patients with suspected biliary tract pathology underwent balloon-assisted enteroscopy in a tertiary-care center. Retrospective analysis of 95 consecutive therapeutic ERCP procedures was performed to define and compare success and complication rate of DBE and SBE. RESULTS: Male-female ratio was 28/45 with a mean age of 58 ± 2 years. 30 (32 %) procedures were performed with DBE and 65 (68 %) with SBE. Overall ERCP success rate was 73 % for DBE and 75 % for SBE (P = 0.831). Failure was due to inability to reach or cannulate the intact papilla or bilioenteric anastomosis. Success rate was significantly higher when performed at the bilioenteric anastomosis (80 % success in 56 procedures) or at the intact papilla in short-limb Roux-en-Y (80 % in 15 procedures) as compared to the intact papilla in long-limb (58 % in 24 procedures; P = 0.040). Adverse event rates were 10 % (DBE) and 8 % (SBE) (P = 0.707) and mostly dealt with conservatively. CONCLUSIONS: ERCP after Roux-en-Y altered small bowel anatomy is feasible and safe using both DBE and SBE. Both techniques are equally competent with high success rates and acceptable adverse events rates. ERCP at the level of the intact papilla in long limb Roux-en-Y is less successful as compared to short-limb or bilioenteric anastomosis.

Histamine H4 and H1 receptors contribute to postinflammatory visceral hypersensitivity.

OBJECTIVES: Substantial evidence implicates mast cells and their main constituent histamine in the pathogenesis of visceral hypersensitivity. We explored the specific contribution of histamine H4 (H4R) and H1 (H1R) receptors to visceral hypersensitivity in a postinflammatory rat model. DESIGN: Trinitrobenzenesulfonic acid (TNBS)-colitis was monitored individually by colonoscopy: first on day 3 to confirm the presence of colitis and then every 4 days, starting from day 10, to monitor convalescence and determine the exact timepoint of endoscopic healing in each rat. Experiments were performed 3 days after endoscopic resolution of colitis. Visceral sensitivity was assessed by quantifying visceromotor responses (VMRs) to colorectal distension. Colonic mast cell numbers, histamine release and H4R and H1R mRNA expression were quantified. JNJ7777120 (H4R antagonist) and/or levocetirizine (H1R antagonist) were administered 30 min prior to VMR assessment or histamine release assay. RESULTS: Postcolitis rats displayed a higher number of colonic mast cells, excessive histamine release and significantly enhanced VMRs. Heightened VMRs were dose-dependently reduced by JNJ7777120 and levocetirizine; combined administration of JNJ7777120 and levocetirizine potentiated the antinociceptive effect. In the colon, both H4R and H1R mRNA were present; in the dorsal root ganglia, only H1R mRNA was found. Only colonic H4R mRNA expression was increased in postcolitis rats. Excessive histamine release in postcolitis rats was attenuated by the highest dose of JNJ7777120. CONCLUSIONS: H4R and H1R antagonists dose-dependently reduce and even normalise postinflammatory visceral hypersensitivity via different underlying mechanisms but with a synergistic effect. Both receptor subtypes represent promising targets for the treatment of postinflammatory visceral hypersensitivity.

The effect of chemically induced colitis, psychological stress and their combination on visceral pain in female Wistar rats.

Visceral sensitivity is of pathophysiological importance in abdominal pain disorders and can be modulated by inflammation and stress. However, it is unclear whether inflammation and stress alter visceral perception independently of each other or in conjunction through neuroendocrine interactions. Therefore, we compared the short- and long-term effects of experimental colitis and water avoidance stress (WAS), alone or in combination, on visceral sensitivity in female Wistar rats. Colitis was induced by trinitrobenzene sulfonic acid (TNBS) and colonoscopically confirmed. During WAS, rats were placed on a platform surrounded by water for 1 h. Visceral sensitivity was assessed by quantifying the visceromotor responses (VMRs) to colorectal distension. Activation of the hypothalamic-pituitary-adrenal axis was determined by measuring serum corticosterone in a separate protocol. TNBS instillation resulted in overt colitis, associated with significant visceral hypersensitivity during the acute inflammatory phase (3 days post-TNBS; n = 8/group); after colitis had subsided (28 days post-TNBS), hypersensitivity was resolved (n = 4-8/group). Single WAS was associated with increased VMRs of a magnitude comparable to acute TNBS-induced hypersensitivity (n = 8/group). However, after repetitive WAS no significant hypersensitivity was present (n = 8/group). No additive effect of colitis and stress was seen on visceral pain perception (n = 6-8/group). Corticosterone levels were only increased in acute TNBS-colitis, acute WAS and their combination. To conclude, both colitis and stress successfully induced short-term visceral hypersensitivity and activated the hypothalamic-pituitary-adrenal axis, but long-term effects were absent. In addition, our current findings do not support an additive effect of colitis and stress on visceral sensitivity in female Wistar rats.