Shyam Varadarajulu

Prospective randomized trial comparing EUS and EGD for transmural drainage of pancreatic pseudocysts (with videos)

BACKGROUND Although prior studies evaluated the role of EUS and EGD for drainage of pancreatic pseudocysts, there are no randomized trials that compared the technical outcomes between both modalities. OBJECTIVE To compare the rate of technical success between EUS and EGD for transmural drainage of pancreatic pseudocysts. STUDY DESIGN A prospective randomized trial. SETTING A tertiary-referral center. PATIENTS Those with a history of pancreatitis and symptomatic pancreatic pseudocysts that measured greater than 4 cm in size who were referred for endoscopic transmural drainage. Patients with pancreatic abscess or necrosis were excluded. MAIN OUTCOME MEASUREMENTS Technical success was defined as the ability to access and drain a pseudocyst by placement of transmural stents. Complications were assessed at 24 hours and at day 30. Treatment success was defined as the complete resolution or decrease in size of the pseudocyst to <or=2 cm on CT in association with clinical resolution of symptoms at 6 weeks of follow-up. RESULTS Thirty patients were randomized to undergo pseudocyst drainage by EUS (n = 15) or EGD (n = 15) over a 6-month period. Of the 15 patients randomized to EUS, drainage was not undertaken in one, because an alternative diagnosis of biliary cystadenoma was established at EUS and was excluded (after randomization) from analysis. The mean age of the patients was 47 years; 62% were men (18/29). Except for their sex, there was no difference in patient or clinical characteristics between the 2 cohorts. Although all the patients (n = 14) randomized to an EUS underwent successful drainage (100%), the procedure was technically successful in only 5 of 15 patients (33%) randomized to an EGD (P < .001). All 10 patients who failed drainage by EGD underwent successful drainage of the pseudocyst on a crossover to EUS. There was no significant difference in the rates of treatment success between EUS and EGD after stenting, either by intention-to-treat (ITT) analysis (100% vs 87%; P = .48) or as-treated analysis (95.8% vs 80%; P = .32). Major procedure-related bleeding was encountered in 2 patients in whom drainage by EGD was attempted; one resulted in death and the other necessitated a blood transfusion. No significant difference was observed between EUS and EGD with regard to complications either by ITT (0% vs 13%; P = .48) or as-treated analyses (4% vs 20%; P = .32). Technical success was significantly greater for EUS than EGD, even after adjusting for luminal compression and sex (adjusted exact odds ratio 39.4; P = .001). LIMITATION Short duration of follow-up. CONCLUSIONS When available, EUS should be considered as the first-line treatment modality for endoscopic drainage of pancreatic pseudocysts given its high technical success rate.

EUS Versus Surgical Cyst-Gastrostomy for Management of Pancreatic Pseudocysts

BACKGROUND Although EUS-guided cyst-gastrostomy is increasingly being performed, there are no studies that compare the clinical outcomes and cost-effectiveness with surgical cyst-gastrostomy. OBJECTIVES To compare the clinical outcomes of EUS-guided cyst-gastrostomy with surgical cyst-gastrostomy for the management of patients with uncomplicated pancreatic pseudocysts and to perform a cost analysis of each treatment modality. DESIGN A retrospective case-controlled study. SETTING A tertiary-referral center. PATIENTS Consecutive patients with uncomplicated pancreatic pseudocysts managed by surgical and EUS-guided cyst-gastrostomy. METHODS An independent observer blinded to all clinic outcomes matched each patient who underwent a surgical cyst-gastrostomy with 2 patients who underwent an EUS-guided cyst-gastrostomy for age, etiology of pancreatitis, and the size of the pseudocyst. MAIN OUTCOME MEASUREMENTS Rates of treatment success, complications, and reinterventions; length of postprocedure hospital stay; and cost associated with each treatment modality. RESULTS Ten patients (6 men; mean age 42.3 years, range 22-65 years) who underwent surgical cyst-gastrostomy were matched with 20 patients who underwent an EUS-guided cyst-gastrostomy. There were no significant differences in demographics, major comorbidities, and clinical characteristics between both cohorts. Although there were no significant differences in rates of treatment success (100% vs 95%, P = .36), procedural complications (none in either cohort), or reinterventions (10% vs 0%, P = .13) between surgery versus an EUS-guided cyst-gastrostomy, the mean length of a postprocedure hospital stay for an EUS-guided cyst-gastrostomy was significantly shorter than for surgical cyst-gastrostomy (2.65 vs 6.5 days, P = .008). The average direct cost per case for EUS-guided cyst-gastrostomy was significantly less when compared with surgical cyst-gastrostomy (

Multiple transluminal gateway technique for EUS-guided drainage of symptomatic walled-off pancreatic necrosis

9077 vs

Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions

14,815, P = .01), which corresponded to a cost savings of

Patient perception of natural orifice transluminal endoscopic surgery as a technique for cholecystectomy.

5738 per patient. LIMITATIONS Retrospective, nonrandomized design; patients with pancreatic abscess or necrosis were not evaluated; a limited sample size and a short duration of follow-up. CONCLUSIONS EUS-guided cyst-gastrostomy should be considered as a first-line treatment approach for patients with uncomplicated pancreatic pseudocysts, because the procedure is cost saving and is associated with a shorter length of a postprocedure hospital stay when compared with surgical cyst-gastrostomy. There was no significant difference in clinical outcomes between both treatment modalities.

The presence of a cytopathologist increases the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration cytology for pancreatic adenocarcinoma: a meta-analysis.

BACKGROUND Walled-off pancreatic necrosis often leads to severe clinical deterioration necessitating open debridement or endoscopic necrosectomy. A new EUS-based approach was devised to manage this condition by creating multiple transluminal gateways to facilitate effective drainage of the necrotic contents. OBJECTIVE To compare treatment outcomes between patients with walled-off pancreatic necrosis managed endoscopically by a multiple transluminal gateway technique (MTGT) or a conventional drainage technique (CDT). DESIGN Retrospective study. SETTING Tertiary-care referral center. PATIENTS This study involved patients with severe acute pancreatitis complicated by walled-off pancreatic necrosis managed endoscopically. INTERVENTION In MTGT, 2 or 3 transmural tracts were created by using EUS guidance between the necrotic cavity and the GI lumen. While one tract was used to flush normal saline solution via a nasocystic catheter, multiple stents were deployed in others to facilitate drainage of necrotic contents. In the CDT, two stents with a nasocystic catheter were deployed via 1 transmural tract. MAIN OUTCOME MEASUREMENTS Resolution of symptoms, radiological findings on follow-up CT, and the need for subsequent surgery or endoscopic necrosectomy. RESULTS Of 60 patients with symptomatic walled-off pancreatic necrosis, 12 (3 women, mean age 55.1 years) were managed by MTGT and 48 (12 women, mean age 55.2 years) by CDT. Treatment was successful in 11 of 12 (91.7%) patients managed by MTGT versus 25 of 48 (52.1%) managed by CDT (P = .01). Although 1 patient in the MTGT cohort required endoscopic necrosectomy, in the CDT cohort, 17 required surgery, 3 underwent endoscopic necrosectomy, and 3 died of multiple-organ failure. Treatment success was more likely for patients treated by MTGT than by CDT (adjusted odds ratio = 9.24; 95% confidence interval, 1.08-79.02; P = .04) when we adjusted for the size of the walled-off pancreatic necrosis and pancreatic duct stent placement. LIMITATIONS Selective patient population. CONCLUSION The EUS-guided MTGT is an effective treatment option for the management of symptomatic walled-off pancreatic necrosis because it obviates the need for surgery and endoscopic necrosectomy and its attendant procedure-related morbidity. Prospective studies are required to confirm these preliminary but promising data.

Frequency and significance of acute intracystic hemorrhage during EUS-FNA of cystic lesions of the pancreas

BACKGROUND To overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS. OBJECTIVE To compare 22-gauge (G) FNA and 22G biopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses. DESIGN Randomized trial. SETTING Tertiary-care medical center. PATIENTS This study involved 56 patients with solid pancreatic masses. INTERVENTION Sampling of pancreatic masses by using 22G FNA or 22G FNB devices. MAIN OUTCOME MEASUREMENTS Compare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen. RESULTS A total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively. LIMITATIONS Only pancreatic masses were evaluated. CONCLUSION Diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types.

Randomized trial comparing fanning with standard technique for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic mass lesions

BACKGROUND Although the concept of natural orifice transluminal endoscopic surgery (NOTES) as a minimally invasive surgical technique is gaining increasing popularity, patient perception toward NOTES is unclear. Because cholecystectomy is the most common laparoscopic procedure, the concept of NOTES was examined in this context. AIM To evaluate patient perception of NOTES as a potential technique for a cholecystectomy. PATIENTS Those patients with an intact gallbladder who were undergoing an EUS or an ERCP for evaluation of abdominal pain, pancreatitis, or suspected choledocholithiasis. SETTING Tertiary-referral center. DESIGN Cross-sectional survey. METHODS One hundred patients were given a questionnaire that described the technique, the complication rates, and benefits of laparoscopic cholecystectomy (LC). The concept of NOTES was then described in detail, with possible orifices being the mouth, the rectum, and the vagina. Patients were queried about their preference for a cholecystectomy technique (LC vs NOTES), choice of orifice, and the risks that they were willing to undergo for NOTES. RESULTS Of the 100 patients, 78% preferred NOTES, and 22% preferred LC. The mean age of the patients was 45 years; 36% of patients were men, 70% were white, and 83% had undergone a prior endoscopy; no significant differences were observed between the NOTES and LC groups for these characteristics. In multivariable modeling, those with age </= 50 years (odds ratio [OR] 1.3, P = .61), female sex (OR 2.1, P = .14), and prior endoscopy experience (OR 2.2, P = .19) were more likely to prefer NOTES than an LC. There was no difference in preference for NOTES between whites and nonwhites (OR 1.0, P = .98). The most common reasons for NOTES preference were lack of external pain (99%) and scarring (89%). Among the patients who preferred NOTES, for both men (23/25 [92%]) and women (43/53 [81%]), the oral route was the preferred orifice. A decreasing trend of patient preference for NOTES was observed with increased procedural complications: patient preference was 100% if complications were <3%, 97% if complications were equal to 3%, 15% if complications were 6%, and 6% if complications were 9%. LIMITATIONS A selective cohort of patients was evaluated. CONCLUSIONS Patients preferred NOTES to laparoscopy as the technique for cholecystectomy as long as the complication rates were comparable with current standards of LC. The oral orifice appeared to be the preferred approach for most patients. Given this favorable perception, further innovations in NOTES-related technology and refinements in procedural technique are justified.

Endoscopic ultrasound‐guided FNA biopsy of bile duct and gallbladder: analysis of 53 cases

A meta‐analysis has not been previously performed to evaluate critically the diagnostic accuracy of endoscopic ultrasound‐guided fine needle aspiration (EUS‐FNA) of solely pancreatic ductal adenocarcinoma and address factors that have an impact on variability of accuracy. The aim of this study was to determine whether the presence of a cytopathologist, variability of the reference standard and other sources of heterogeneity significantly impacts diagnostic accuracy.

Value of repeat endoscopic ultrasound‐guided fine needle aspiration for suspected pancreatic cancer

BACKGROUND Complications from EUS-guided FNA of cystic lesions of the pancreas are infrequent. Although several studies have evaluated infectious complications of EUS-guided FNA in this setting, the frequency and the clinical significance of intracystic hemorrhage have not been determined. This study assessed the frequency of acute intracystic hemorrhage during EUS-guided FNA of pancreatic cystic lesions. The characteristic EUS appearance is described. METHODS EUS-guided FNA of pancreatic cyst lesions was performed in 50 patients (July 2000 to June 2003). Patients were followed prospectively for the development of complications. OBSERVATIONS Acute intracystic hemorrhage occurred during EUS-guided FNA at the site of aspiration in 3 patients (6%: 95% confidence interval [1.3%, 16.6%]). Endosonographically, the bleeding manifested as a small hyperechoic area at the puncture site that progressed gradually over a few minutes to involve the majority of the cyst cavity. EUS-guided FNA was terminated when bleeding was observed. One patient was asymptomatic, but two patients experienced abdominal pain transiently. All patients were treated with a short course of orally administered antibiotics and were observed as outpatients. Clinical history and laboratory parameters did not predict which patients were at risk for intracystic hemorrhage. CONCLUSIONS Acute intracystic hemorrhage is a rare complication of EUS-guided FNA; it has a characteristic EUS appearance. Recognition of this event is important, because it permits termination of the procedure and thereby minimizes the potential for more serious bleeding.