Jason B. Samarasena

High single-pass diagnostic yield of a new 25-gauge core biopsy needle for EUS-guided FNA biopsy in solid pancreatic lesions

BACKGROUND Current limitations of EUS-guided FNA include the need for multiple passes and on-site cytology assessment and lack of core specimen. Recently, a new 25-gauge core biopsy needle (PC25) was developed to overcome these limitations. OBJECTIVE To determine the diagnostic yield of EUS-guided FNA aspiration biopsy (FNAB) when using the PC25 needle among patients with solid pancreatic lesions. DESIGN Retrospective analysis. SETTING Academic tertiary referral center. PATIENTS Fifty consecutive patients with a solid pancreatic lesion underwent EUS-guided FNAB with PC25. INTERVENTIONS EUS-guided FNAB with PC25. MAIN OUTCOME MEASUREMENTS The primary outcome was the diagnostic yield in single and overall passes of EUS-guided FNAB when using the PC25 needle for pancreatic solid lesions. RESULTS Cytologic analysis showed malignancy in 38 patients on the first pass, with a cumulative sensitivity of 83%, 91%, and 96% on passes 1, 2, and 3, respectively. Although visible core was reported in 46 patients (92%), histologic core was seen in 16 patients (32%). Histologic analysis showed malignancy in 29 patients on the first pass, with a cumulative sensitivity of 63% and 87% on pass 1 and passes 1 to 4, respectively. The sensitivity, specificity, and accuracy in combined cytologic and histologic results were 85%, 100%, and 86% for single pass and 96%, 100%, and 96% on multiple passes, respectively. No complications were seen. LIMITATIONS A retrospective study design at a single center using a single arm. CONCLUSION EUS-guided FNAB with the PC25 needle showed excellent single-pass and overall diagnostic yields. This needle appears to maintain a high cytologic yield, similar to standard 25-gauge FNA needles, while also providing some histologic core tissue.

Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study.

BACKGROUND The diagnosis of pancreatic cystic neoplasms (PCNs), which now depends on morphology, cytology, and fluid analysis, is still challenging. A novel confocal laser endomicroscopy probe that can be inserted through a 19-gauge FNA needle allows needle-based confocal laser endomicroscopy (nCLE), and the feasibility of nCLE has been reported in PCNs. The combination of cystoscopy by using a through-the-needle fiberoptic probe in combination with nCLE under EUS guidance may improve the diagnosis of PCNs. OBJECTIVE To assess the feasibility, safety, and diagnostic yield of the combination of cystoscopy and nCLE in the clinical diagnosis of PCNs. DESIGN A prospective feasibility study. SETTING An academic tertiary referral center. PATIENTS Thirty patients with PCNs. INTERVENTIONS EUS-guided dual through-the-needle imaging (cystoscopy and nCLE) for PCNs. MAIN OUTCOME MEASUREMENTS Technical feasibility and safety. Associations of cystoscopy and nCLE findings with clinical diagnosis of PCNs. RESULTS The procedure was technically successful with the exception of 1 probe exchange failure. In 2 patients (7%), postprocedure pancreatitis developed. Specific features associated with the clinical diagnosis of mucinous cysts were identified: mucin on cystoscopy and papillary projections and dark rings on nCLE. The sensitivity of cystoscopy was 90% (9/10), and that of nCLE was 80% (8/10), and the combination was 100% (10/10) in 18 high-certainty patients. LIMITATIONS A single-center study and lack of complete pathologic correlation. CONCLUSION The combination of dual through-the-needle imaging (cystoscopy and nCLE) of pancreatic cysts appears to have strong concordance with the clinical diagnosis of PCN. ( CLINICAL TRIAL REGISTRATION NUMBER NCT01447238.).

Split-Dosed MiraLAX / Gatorade Is an Effective, Safe, and Tolerable Option for Bowel Preparation in Low-Risk Patients: A Randomized Controlled Study

OBJECTIVES:MiraLAX with Gatorade is a low-volume bowel preparation regimen that has been used widely in community practice and is anecdotally better tolerated than Golytely. Despite its widespread use, there are little data on the efficacy and tolerability of this solution and no safety data in the literature. The primary aim of this study was to compare the efficacy, safety, and tolerability of single-dosed and split-dosed regimens of MiraLAX/Gatorade with Golytely for bowel preparation before colonoscopy.METHODS:Adults presenting for outpatient colonoscopy were screened for enrollment into this single-blinded randomized controlled trial. Patients with severe cardiac or renal disease and patients with electrolyte abnormalities were excluded. Subjects were randomized into four groups: 4 l Golytely single-dosed (Go-Si), 4 l Golytely split-dosed (Go-Sp), 238 g MiraLAX in 64 oz of Gatorade single-dosed (Mlax-Si), and MiraLAX/Gatorade split-dosed (Mlax-Sp) groups. Laboratory data including complete blood count, comprehensive metabolic panel, and osmolality were collected before the day of bowel preparation and just before the start of colonoscopy. Subjects completed a survey assessing taste and tolerability of the solution. Colonoscopies were recorded using video recording software and de-identified. Colonoscopy videos were evaluated for efficacy of cleansing by two blinded endoscopists. Two validated bowel preparation scales were used to assess bowel cleansing: the Boston Bowel Preparation Scale (BBPS; 0–9 best) and Ottawa Scale (0–14 worst).RESULTS:A total of 222 patients were evaluated in this study (86.2% male, mean age 59.4). Of these, 57 subjects were randomized to the Go-Si group, 51 to Go-Sp group, 60 to Mlax-Si group, and 54 to Mlax-Sp group. There was no significant difference in age, gender, or timing of colonoscopy between the groups (P>0.05). Mean BBPS scores were: Go-Si=6.07, Go-Sp=8.33, Mlax-Si=6.62, and Mlax-Sp=8.01. Mean Ottawa score for the groups were: Go-Si group=6.77, Go-Sp=4.12, Mlax-Si=6.25, and Mlax-Sp=4.8. Go-Sp resulted in significantly better cleansing than Go-Si (P<0.01). Mlax-Sp resulted in significantly better cleansing than Mlax-Si (P<0.01). There was no significant difference in BBPS between Go-Sp and Mlax-Sp. There were no clinically significant electrolyte changes from baseline in any subject in any group after bowel prep (P>0.05). Subjects rated the taste and overall experience of Mlax/Gatorade preparation better than Golytely (P<0.01). In all, 96.8% of Mlax/Gatorade subjects were willing to repeat the same preparation vs. 75% for Golytely subjects (P<0.01).CONCLUSIONS:Split-dosed MiraLAX/Gatorade was an effective, safe, and tolerable option for bowel preparation before colonoscopy in the low-risk patients in this study. MiraLAX/Gatorade appears to be more tolerable than Golytely as a bowel cleansing regimen and was the preferred agent by the patients in this study.

Confocal laser endomicroscopy in gastrointestinal and pancreatobiliary diseases.

Confocal laser endomicroscopy (CLE) is an emerging diagnostic procedure that enables in vivo pathological evaluation during ongoing endoscopy. There are two types of CLE: endoscope‐based CLE (eCLE), which is integrated in the tip of the endoscope, and probe‐based CLE (pCLE), which goes through the accessory channel of the endoscope. Clinical data of CLE have been reported mainly in gastrointestinal (GI) diseases including Barretts esophagus, gastric neoplasms, and colon polyps, but, recently, a smaller pCLE, which goes through a catheter or a fine‐needle aspiration needle, was developed and clinical data in the diagnosis of biliary stricture or pancreatic cysts have beenincreasingly reported. The future application of this novel technique expands beyond the pathological diagnosis to functional or molecular imaging. Despite these promising data, the generalizability of the procedure should be confirmed especially in Japan and other Asian countries, where the current diagnostic yield for GI luminal diseases is high. Given the high cost of CLE devices, cost–benefit analysis should also be considered.

Decreasing in-hospital mortality for oesophageal variceal hemorrhage in the USA.

Background To date, no study has analyzed nationwide trends of in-hospital mortality related to oesophageal variceal hemorrhage in the USA. The aim of this study was to analyze trends of in-hospital mortality related to oesophageal variceal bleeding over the past two decades using a large national database. In addition, our aim was to study patient demographics and to identify risk factors for in-hospital mortality based on administrative data routinely collected in this population. Methods The nationwide inpatient sample database was used from 1988 to 2004. Patients with an International Classification of Diseases, ninth revision, Clinical Modification discharge diagnosis of oesophageal variceal bleeding were included. Patient demographics, hospital, and admission characteristics were collected. t-test and Poisson regression analysis were used to evaluate trends. Logistic regression analysis was performed to determine the relationship between mortality and patient/hospital characteristics. Results From 1988 to 2004, crude in-hospital mortality decreased from 18 to 11.5%, whereas the age-adjusted in-hospital mortality rate decreased 45.4% from 1289 per 100 000 to 704 per 100 000 (P<0.01). Mortality was consistently higher for males and for African–Americans over the study period. For the 2001 dataset, multivariate logistic regression analysis showed that male sex, African–American race, age, large hospital size, urban location, teaching hospitals, and hospitals located in the northeast were independent risk factors for increased mortality. Conclusion The in-hospital mortality of patients with oesophageal variceal bleeding has decreased over the past two decades and is likely due to the advances made in the acute management of variceal bleeding as well as improved resuscitative methods. Male sex, African–American race, age, large hospital size, urban location, teaching hospitals, and hospitals located in the northeast are independent risk factors for increased in-hospital mortality.

Use of the Endocuff during routine colonoscopy examination improves adenoma detection: A meta-analysis

AIM To perform meta-analysis of the use of Endocuff during average risk screening colonoscopy. METHODS Scopus, Cochrane databases, MEDLINE/PubMed, and CINAHL were searched in April 2016. Abstracts from Digestive Disease Week, United European Gastroenterology, and the American College of Gastroenterology meeting were also searched from 2004-2015. Studies comparing EC-assisted colonoscopy (EAC) to standard colonoscopy, for any indication, were included in the analysis. The analysis was conducted by using the Mantel-Haenszel or DerSimonian and Laird models with the odds ratio (OR) to assess adenoma detection, cecal intubation rate, and complications performed. RESULTS Nine studies (n = 5624 patients) were included in the analysis. Compared to standard colonoscopy, procedures performed with EC had higher frequencies for adenoma (OR = 1.49, 95%CI: 1.23-1.80; P = 0.03), and sessile serrated adenomas detection (OR = 2.34 95%CI: 1.63-3.36; P < 0.001). There was no significant difference in cecal intubation rates between the EAC group and standard colonoscopy (OR = 1.26, 95%CI: 0.70-2.27, I2 = 0%; P = 0.44). EAC was associated with a higher risk of complications, most commonly being superficial mucosal injury without higher frequency for perforation. CONCLUSION The use of an EC on colonoscopy appears to improve pre-cancerous polyp detection without any difference in cecal intubation rates compared to standard colonoscopy.

Endoscopic Ultrasonography- Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions: A Practical Approach to Diagnosis and Management

The diagnosis and management of pancreatic cystic lesions remains a challenging area in gastroenterology. Differentiating benign from premalignant or premalignant from malignant cysts is complicated by the large overlap in morphologic, chemical, and clinical characteristics. Imaging alone is insufficient to accurately characterize these lesions. Cyst aspiration and fluid analysis has therefore become a major research focus through which our ability to characterize pancreatic cystic lesions has improved, although accuracy is often still lacking. Future work with molecular analysis of cyst fluid, direct cystoscopy, and confocal laser endomicroscopy will likely further enhance the diagnostic accuracy of these lesions.

Declining hospitalization rate of esophageal variceal bleeding in the United States.

BACKGROUND & AIMS In recent years, there have been many advances in the primary and secondary prophylaxis of variceal bleeding. The aim of this study was to evaluate nationwide trends in the hospitalization rate of bleeding esophageal varices in the advent of these new modalities. In addition, our aims were to study the incidence trends of nonbleeding esophageal varices over the past 2 decades while studying hospitalization rates for cirrhosis over the same study period. METHODS The Nationwide Inpatient Sample database was used for inpatient data analysis (1988-2002) and the State Ambulatory Surgery Database was used for outpatient analysis. Patients discharged with International Classification of Diseases, ninth revision, Clinical Modification discharge diagnoses related to esophageal varices were included. RESULTS The hospitalization rate of bleeding varices increased 13.7% from 10.9 per 100,000 in the 1988 to 1990 period to 12.4 per 100,000 in the 1994 to 1996 period (P < .01), and then decreased 14.5% to 10.6 per 100,000 in the 2000 to 2002 period (P < .01). In-hospital nonbleeding varices increased 55% from 6.0 to 9.3 per 100,000 from the 1988 to 1990 period to the 2000 to 2002 period (P < .01). Outpatient nonbleeding esophageal varices increased 20% from 5.5 to 6.6 per 100,000 from 1997 to 2003. CONCLUSIONS The hospitalization rate for bleeding esophageal varices has been on the decline in recent years and may be a reflection of the advances in primary and secondary prophylaxis. The incidence rate of nonbleeding esophageal varices is increasing and likely is owing to the increasing burden of portal hypertensive liver disease in the nation.

EUS-guided portal pressure gradient measurement with a novel 25-gauge needle device versus standard transjugular approach: a comparison animal study

BACKGROUND AND AIMS Portal hypertension (PH) is a serious adverse event of liver cirrhosis. The hepatic venous pressure gradient (HVPG) accurately reflects the degree of PH and is the single best prognostic factor in liver disease. Currently, portal pressure gradient (PPG) measurement is performed at interventional radiology (IR) with a standard transjugular approach requiring radiation and intravenous contrast. The aim of this study was to develop a novel EUS-guided system using a 25G FNA needle and compact manometer to directly measure PPG and to evaluate its performance and clinical feasibility. METHODS Experiments were performed in 3 swine that were under general anesthesia. Manometry was performed in venous (baseline and PH) and arterial (aorta) systems. The PH model was created by rapid Dextran-40 infusion peripherally. Under EUS guidance a 25G FNA needle with attached manometer was used to puncture (transgastric-transhepatic approach) and measure pressures in the portal vein, right hepatic vein (RHV), inferior vena cava (IVC), and aorta. With the IR approach, RHV (free and wedged), IVC, and aorta pressure were measured with an occlusion balloon. Pressure correlation was divided into 3 groups; low pressure (baseline), medium pressure (noncirrhotic portal hypertensive model), and high pressure (arterial). Correlation between the 2 methods of measurement was charted in scatter plots, and the Pearsons correlation coefficient (R) was calculated. RESULTS EUS identification, access, and manometry was successful in all targeted vessels. There was excellent correlation (R, .985-.99) between EUS and IR methods in all pressure ranges. No adverse event occurred. CONCLUSIONS This novel technique of EUS-PPG measurement using a 25G needle and novel manometer was feasible and demonstrated excellent correlation with the standard transjugular method throughout low, medium, and high pressure ranges.

Successful management of perforation during cystogastrostomy with an esophageal fully covered metallic stent placement

A 49-year-old woman presented for endoscopic treatment of symptomatic pseudocyst refractory to conservative management for the past year. EUS showed a thickwalled 49 39-mm pseudocyst in the pancreatic tail in close opposition to the gastric fundus. The cyst was punctured by using a 19-gauge FNA needle (Fig. 1) followed by guidewire placement and dilation of the fistula with a needle-knife cautery and a 6-mm balloon. Attempted placement of a 10F, 4-cm long double-pigtail stent resulted in dislodgment of the guidewire from the pseudocyst because of extreme angulation of the endoscope required to obtain a satisfactory endoscopic view. The guidewire was re-placed into what appeared to be the pseudocyst cavity under endoscopic control, and balloon dilation was repeated using a 12-mm balloon. Fluoroscopic examination showed possible free air at this point, and thus, the echoendoscope was exchanged for a gastroscope to examine the cystogastrostomy tract. Endoscopy showed a clear perforation next to the true lumen of the cystogastrostomy tract (Fig. 2). We then placed an 18 70-mm esophageal fully covered self-expandable metallic stent (FCMS) (ALIMAXX-ES; Merit Medical Endotek, South Jordan, Utah) by using a stiff guidewire (Savary-Gilliard Wire Guides; Cook Medical Inc, Bloomington, Ind) into the pseudocyst cavity to drain it and to seal the perforation (Fig. 2). Broad-spectrum antibiotics were initiated during the procedure. Abdominal CT after the procedure showed free air and the stent to be in good position (Fig. 3). No pain or other signs of peritonitis developed in the patient, and she was discharged after 48 hours of observation on oral antibiotics. The stent was removed uneventfully 1 month later after repeat CT scan confirmed resolution of the pseudocyst.