Severe Acute Pancreatitis Prediction: A Model Derived From a Prospective Registry Cohort.

Background Severe acute pancreatitis (SAP) has a mortality rate as high as 40%. Early identification of SAP is required to appropriately triage and direct initial therapies. The purpose of this study was to develop a prognostic model that identifies patients at risk for developing SAP of patients managed according to a guideline-based standardized early medical management (EMM) protocol. Methods This single-center study included all patients diagnosed with acute pancreatitis (AP) and managed with the EMM protocol Methodist Acute Pancreatitis Protocol (MAPP) between April 2017 and September 2022. Classification and regression tree (CART®; Professional Extended Edition, version 8.0; Salford Systems, San Diego, CA), univariate, and logistic regression analyses were performed to develop a scoring system for AP severity prediction. The accuracy of the scoring system was measured by the area under the receiver operating characteristic curve. Results A total of 516 patients with mild (n=436) or moderately severe and severe (n=80) AP were analyzed. CART analysis identified the cutoff values: creatinine (CR) (1.15 mg/dL), white blood cells (WBC) (10.5 × 109/L), procalcitonin (PCT) (0.155 ng/mL), and systemic inflammatory response system (SIRS). The prediction model was built with a multivariable logistic regression analysis, which identified CR, WBC, PCT, and SIRS as the main predictors of severity. When CR and only one other predictor value (WBC, PCT, or SIRS) met thresholds, then the probability of predicting SAP was >30%. The probability of predicting SAP was 72% (95%CI: 0.59-0.82) if all four of the main predictors were greater than the cutoff values. Conclusions Baseline laboratory cutoff values were identified and a logistic regression-based prognostic model was developed to identify patients treated with a standardized EMM who were at risk for SAP.

Esophageal Perforation and Pneumomediastinum Due to Delayed Diagnosis of Esophageal Lichen Planus.

Esophageal involvement of lichen planus is an under-reported and under-diagnosed manifestation that should prompt immediate treatment given its high rate of complications. We highlight a rare case of a 62-year-old Caucasian woman with history of known oral lichen planus and esophageal strictures presumed to be secondary to gastroesophageal reflux disease, that presented with esophageal food impaction resulting in perforation and subsequent pneumomediastinum after esophagogastroduodenoscopy (EGD). Further workup, including a repeat EGD, revealed that the esophageal strictures were rather a complication of lichen planus. The patient was started on oral, topical steroids and underwent serial esophageal dilations with improvement. Esophageal lichen planus should be high on the differential, especially in patients with involvement of other mucous membranes and strictures refractory to therapy. Complications such as recurrent esophageal strictures and perforation may be preventable with early diagnosis and adequate treatment.

First interobserver agreement of optical coherence tomography in the bile duct: A multicenter collaborative study.

Background and study aims Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data.

Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures: The Monaco Classification.

BACKGROUND: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. MATERIALS AND METHODS: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. RESULTS: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. CONCLUSIONS: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

Ablative therapies of the biliary tree.

Cholangiocarcinoma, a malignancy of the epithelial cells in the intrahepatic or extrahepatic biliary tree, is often diagnosed at later stages. Median survival duration ranges from 3 to 9 months with a less than ten percent 5-year survival rate. Thus, often treatment strategies are aimed more towards palliation instead of cure. With the majority of patients presenting with unresectable disease at the time of diagnosis, surgical intervention is not feasible, making less invasive endoscopic therapies more suitable. Initially, biliary stents were utilized for biliary decompression to mitigate cholestatic symptoms and prevent cholangitis; however, this strategy did not prove to provide significant survival benefit. Therefore, efforts to treat the tumor burden itself in addition to maintaining biliary patency became a focus of innovation and research in the endoscopic field. This study has led to the advent of therapies such as photodynamic therapy, radiofrequency ablation, and intraluminal brachytherapy. These options combined with biliary stenting have shown to not only offer the benefit of biliary decompression, but also to potentially improve stent patency and survival. Further, there is an anti-tumor effect of each of these modalities, portending an additional benefit in this subset of patients. Despite numerous retrospective and prospective studies assessing these ablative therapies, there is still a paucity of appropriately powered randomized controlled trials, and further research has yet to be done in the field. This review details the current literature entailing endobiliary ablative strategies.

Probe-based confocal laser endomicroscopy in the evaluation of dominant strictures in patients with primary sclerosing cholangitis: results of a U.S. multicenter prospective trial.

BACKGROUND AND AIMS: Patients with primary sclerosing cholangitis (PSC) and dominant biliary strictures carry increased risk for the development of cholangiocarcinoma. Although ERCP-based techniques including brush cytology and intraductal biopsy sampling represent first-line tissue sampling methods for dominant strictures, sensitivity is low. Probe-based confocal laser endomicroscopy (pCLE) offers microscopic-level imaging of subepithelial biliary mucosa. Because data regarding the use of pCLE in PSC are limited, we aimed to investigate its diagnostic performance in dominant strictures. METHODS: This was a multicenter prospective study involving PSC patients with dominant strictures. ERCP with pCLE was performed with use of the Miami classification (2+ criteria for malignant diagnosis) and Paris classification. Final malignant diagnoses required histopathologic confirmation, and benign diagnoses required a minimum of 1 year of follow-up without development of cancer. RESULTS: Fifty-nine patients (mean age, 49 years; 59% men) with 63 strictures were included in the study. Stricture locations included the common bile duct (31.7%), bifurcation (22.2%), and common hepatic duct (19%). Seven patients (11.9%) were found to have cholangiocarcinoma. The sensitivity and specificity of pCLE was 85.7% (95% confidence interval [CI], 42.1-99.6) and 73.1% (95% CI, 58.9-84.4), respectively. Within specific stricture locations, the highest sensitivity was seen at the bifurcation (100%; 95% CI, 2.5-100) and the right hepatic duct (100%; 95% CI, 29.2-100). The lowest sensitivities were seen at the common bile duct (25%; 95% CI, 5.5-57.2) and the left hepatic duct (28.6%; 95% CI, 3.7-70.9). CONCLUSIONS: In this prospective multicenter study, pCLE had a high sensitivity in detecting cholangiocarcinoma, but technical aspects of the probe may limit evaluation in the common bile duct and left hepatic duct. Further evaluation is needed to elucidate the role of pCLE in the algorithm of excluding neoplasia in biliary strictures associated with PSC. (Clinical trial registration number: NCT02736708.).

Learning curve for EUS-guided biliary drainage: What have we learned?

BACKGROUND AND OBJECTIVE: EUS-guided-biliary drainage (EUS-BD) is an efficacious and safe option for patients who fail ERCP. EUS-BD is a technically challenging procedure. The aim of this study was to define the learning curve for EUS-BD. METHODS: Consecutive patients undergoing EUS-BD by a single operator were included for a prospective registry over 6 years. Demographics, procedural information, adverse events, and follow-up data were collected. Nonlinear regression and CUSUM analyses were conducted for the learning curve. Technical success was defined as successful stent placement. Clinical success was defined as resolution of jaundice and/or at least a 30% reduction in the pretreatment bilirubin level within a week after placement or normalization of bilirubin within 30 days. RESULTS: Seventy-two patients were included in the study (53% male, mean age 67 years). Technical success was achieved in 69 patients (96%). Clinical success was achieved in 59/69 patients (86%). Seven patients (10%) had adverse events including bleeding (n = 6) and liver abscess (n = 1). The median procedural time was 59 min (range 36-138 min). This was achieved at the 32nd procedure. Procedural durations were further reduced to 50 min and below after the 50th procedure in a nonlinear pattern. This suggests that procedural durations approach a potential plateau after 100 cases. CONCLUSION: Endoscopists experienced in EUS-BD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 59 min and a learning rate of 32 cases. Continued improvement is demonstrated with additional experience, with mastery suggested after approximately 100 cases.

EUS-guided pancreatic drainage: A steep learning curve.

BACKGROUND AND OBJECTIVE: EUS-guided pancreatic drainage (EUS-PD) is an efficacious, acceptable risk option for patients with pancreatic duct obstruction who fail conventional ERCP. The aim of this study was to define the learning curve (LC) for EUS-PD. METHODS: Consecutive patients undergoing EUS-PD by a single operator were included from a dedicated registry. Demographics, procedural info, adverse events, and follow-up data were collected. Nonlinear regression and cumulative sum (CUSUM) analyses were conducted for the LC. RESULTS: Fifty-six patients were included (54% of male, with a mean age of 58 years). Technical success was achieved in 47 patients (84%). Stent placement was antegrade in 36 patients (77%) and retrograde in 11 (23%). Clinical success was achieved in 46/47 (98%) patients who achieved technical success. Adverse events were seen in 13 patients (6 of whom did not achieve technical success) and included bleeding requiring embolization (n = 5), bleeding treated with clips peri-procedurally (n = 1), pancreatitis (n = 5), and a pancreatic fluid collection drained via EUS-drainage (n = 2). The median procedural time was 80 min (range 49-159 min). The CUSUM chart showed that 80-min procedural time was achieved at the 27th procedure. Durations further reduced 40th procedure onward, reaching a plateau indicating proficiency (nonlinear regression P < 0.0001). CONCLUSION: Endoscopists experienced in EUS-PD are expected to achieve a reduction in procedural time over successive cases, with efficiency reached at 80 min and a learning rate of 27 cases. Continued improvement is demonstrated with additional experience, with plateau indicating mastery suggested at the 40th case. EUS-PD is probably one of the hardest therapeutic endosonographic procedures to learn.

EUS-Directed Transgastric Endoscopic Retrograde Cholangiopancreatography (EDGE): The First Learning Curve.

INTRODUCTION: Endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) is a minimally invasive option for pancreaticobiliary access in patients with Roux-en-Y anatomy. The procedure involves creating a fistulous tract between the remnant stomach or jejunum and the bypassed stomach with the deployment of a lumen-apposing metal stent (LAMS), followed by the advancement of an endoscope through the LAMS to perform an ERCP or EUS. It is a technically challenging procedure, requiring skills in EUS, fluoroscopy, and LAMS deployment. The aim of this study was to determine the learning curve for EDGE. METHODS: Consecutive patients undergoing EDGE by a single operator were included from a prospective registry over 3 years. Demographics, procedure info, postprocedure follow-up data, and adverse events were collected. Nonlinear regression and cumulative sum analyses were conducted for the learning curve. Technical success was defined as the successful creation of the fistulous tract. Clinical success was defined as successful EUS or ERCP via the LAMS. RESULTS: Nineteen patients were included (21% male, mean age 58.7 y). Indication included symptomatic biliary stricture (n=6, 32%), choledocholithiasis (n=5, 26%), pancreatitis (n=3, 16%). Technical success was 100%. All patients had a 15 mm LAMS placed, 3 (16%) had cautery-enhanced LAMS. Clinical success was achieved in 18/19 (95%) patients. Fourteen patients had an ERCP, 1 patient had a EUS, and 3 patients had both. Adverse events included 2 cases of bleeding, 1 case of post-ERCP pancreatitis, and 1 jejunal perforation during duodenoscope insertion managed endoscopically.Median procedure time was 54.5 minutes (range: 31 to 88 min). Cumulative sum chart shows a 54-minute procedure time was achieved at the ninth procedure hence indicating efficiency. Apart from 2 outliers, the procedure duration further reduced with consequent procedures with the last 3 being under 40 minutes indicating that after 25 to 35 procedures a plateau may be reached indicating mastery (nonlinear regression P<0.0001). CONCLUSIONS: Endoscopists experienced in EDGE are expected to achieve a reduction in procedure time over successive cases, with efficiency reached 54.5 minutes and a learning rate of 9 cases. After 25 to 35 procedures, a plateau may be reached indicating mastery.

SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications.

OBJECTIVES: In patients with acute recurrent pancreatitis (ARP), pancreas divisum, and no other etiologic factors, endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) is often performed to enlarge the minor papillary orifice, based on limited data. The aims of this study are to describe the rationale and methodology of a sham-controlled clinical trial designed to test the hypothesis that miES reduces the risk of acute pancreatitis. METHODS: The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES versus endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having 2 or more discrete episodes of acute pancreatitis, pancreas divisum confirmed by magnetic resonance cholangiopancreatography, and no other clear etiology for acute pancreatitis will be randomized. Both cohorts will be followed for a minimum of 6 months and a maximum of 48 months. RESULTS: The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency. CONCLUSIONS: The SHARP trial will determine whether ERCP with miES benefits patients with idiopathic ARP and pancreas divisum. Trial planning has informed the importance of blinded outcome assessors and long-term follow-up.

EUS-guided drainage of pancreatic fluid collections using lumen apposing metal stents: An international, multicenter experience.

INTRODUCTION: Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs. METHODS: Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up. RESULTS: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ±â€¯3.8. Mean PFC size was 11.9 cm (range 2-25). The median number of endoscopic interventions was 2 (range 1-14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs. CONCLUSION: LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution.

Endoscopic Management of Complex Biliary Stone Disease.

Choledocholithiasis is a common disorder that is managed universally by endoscopic retrograde cholangiopancreatography (ERCP). For difficult or complex stones, ERCP with conventional techniques may fail to achieve biliary clearance in 10% to 15% of cases. This review summarizes the literature regarding the current available endoscopic techniques for complex stone disease, including mechanical lithotripsy, endoscopic papillary large balloon dilation, cholangioscopy-guided lithotripsy, and endoscopic ultrasound-guided biliary access.

EUS-directed Transgastric ERCP (EDGE) Versus Laparoscopy-assisted ERCP (LA-ERCP) for Roux-en-Y Gastric Bypass (RYGB) Anatomy: A Multicenter Early Comparative Experience of Clinical Outcomes.

BACKGROUND AND AIMS: The standard of care for managing pancreaticobiliary disease in altered Roux-en-Y gastric bypass patients is laparoscopy-assisted endoscopic retrograde cholangiopancreatography (LA-ERCP), but is limited by cost and adverse events. Recently a minimally invasive, completely endoscopic approach using endoscopic ultrasound (EUS) directed transgastric ERCP (EDGE) has been described. We aim to compare EDGE to LA-ERCP in this study. METHODS: Patients from May 2005 to June 2017 with Roux-en-Y gastric bypass anatomy having undergone LA-ERCP or EDGE at 4 tertiary centers were captured in a registry. Patient demographics, procedural details, and clinical outcomes were measured for each group. RESULTS: Seventy-two patients (n=29 EDGE, n=43 LA-ERCP) were included in this study. There was no significant difference in the technical success of EDGE gastrogastric fistula (96.5%) versus LA-gastrostomy creation (100%). The success rate of achieving therapeutic ERCP (EDGE 96.5% vs. LA-ERCP 97.7%) and number of ERCP (EDGE 1.2 vs. LA-ERCP 1.02) needed to achieve clinical resolution was similar between both groups. Adverse event rate for EDGE, 24% (7/29) and LA-ERCP, 19% (8/43) was similar. The total procedure time (73 vs. 184 min) and length of hospital stay (0.8 vs. 2.65 d) was significantly shorter for EDGE compared to LA-ERCP. The overall weight change after EDGE was -6.6 lbs at an average 28-week follow-up. CONCLUSIONS: This study suggests that the EDGE procedure has similar technical success and adverse events compared with LA-ERCP with the benefit of significantly shorter procedure times and hospital stay. EDGE may offer a minimally invasive, effective option, with less resource utilization, and without significant weight gain.

Post-cholecystectomy syndrome and sphincter of Oddi dysfunction: past, present and future.

INTRODUCTION: Post-cholecystectomy syndrome and the concept of a causal relationship to sphincter of Oddi dysfunction, despite the controversy, has presented a clinically relevant conflict for decades. Historically surgeons, and now gastroenterologists have expended tremendous efforts towards trying to better understand the dilemma that is confounded by unique patient phenotypes. Areas covered: This review encompasses the literature from a century of experience on the topic of post-cholecystectomy syndrome. Relevant historical and anecdotal experiences are examined in the setting of insights from evaluation of recently available controlled data. Expert commentary: Historical observations and recent data suggest that patients with post-cholecystectomy syndrome can be categorized as follows. Patients with sphincter of Oddi stenosis will most often benefit from treatment with sphincterotomy. Patients with classic biliary pain and some objective evidence of biliary obstruction may have a sphincter of Oddi disorder and should be considered for endoscopic evaluation and therapy. Patients with atypical post-cholecystectomy pain, without any evidence consistent with biliary obstruction, and/or with evidence for another diagnosis or dysfunction should not undergo ERCP.

Endoscopic drainage of pancreatic fluid collections using a fully covered expandable metal stent with antimigratory fins.

BACKGROUND AND OBJECTIVES: Endoscopic drainage is the first consideration in treating pancreatic fluid collections (PFCs). Recent data suggests it may be useful in complicated PFCs as well. Most of the available data assess the use of plastic stents, but scarce data exists on metal stent management of PFCs. The aim of our study to evaluate the efficacy and safety of a metal stent in the management of PFCs. PATIENTS AND METHODS: Data were collected prospectively on 47 patients diagnosed with PFCs from March 2007 to August 2011 at 3 tertiary care centers. These patients underwent endoscopic transmural placement of a fully covered self-expanding metal stent (FCSEMS) with antimigratory fins of 10 mm diameter. RESULTS: The stent was successfully placed in all patients, and left in place an average of 13 weeks (range 0.4-36 weeks). Etiology of the PFC was biliary pancreatitis (23), pancreas divisum (2), trauma (4), hyperlipidemia (3), alcoholic (8), smoking (2), idiopathic (4), and medication-induced (1). PFCs resolved in 36 patients, for an overall success rate of 77%. Complications included fever (3), stent migration (2) and abdominal pain (1). CONCLUSIONS: The use of FCSEMS is successful in the majority of patients with low complication rates. A large sample-sized RCT is needed to confirm if the resolution of PFCs is long-standing.