Ashutosh Tamhane

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-guided FNA of solid pancreatic masses: a learning curve with 300 consecutive procedures

BACKGROUND The objective of our study was to assess a single operators learning curve with regard to the number of passes, the diagnostic accuracy, and the complications associated with EUS-guided FNA (EUS-FNA) of solid pancreatic masses. METHODS The number of passes, the diagnostic accuracy, and the complication rate were prospectively evaluated in 300 consecutive EUS-FNA of solid pancreatic masses performed by a single endosonographer over a 3-year period. The procedures were placed into 3 groups, which contained 100 procedures each. The endosonographer had undergone a third-tier EUS fellowship and had performed 45 supervised pancreatic EUS-FNA during his training. RESULTS Of the 300 EUS-FNA performed (median age 63 years, 64% men), no statistically significant differences among the 3 groups with regard to age, gender, race, location, or size of the mass were found. Diagnostic accuracy of the EUS-FNA procedure was similar over time (Group 1, 92%; Group 2, 92%; Group 3, 95%). Median number of passes showed a decreasing trend over the 3-year study period, despite an increasing trend of the number of procedures performed (r = -0.14, p = 0.42). The median number of passes was lower for Group 2 (median, 3; p = 0.02) and Group 3 (median, 3; p = 0.003) compared with Group 1 (median, 4). Group 3 (7/100, 7%) was less likely to encounter complications compared with Group 1 (13/100, 13%; p = 0.24) and Group 2 (18/100, 18%; p = 0.03). Frequency of serious complications was similar across the 3 groups (1%-3%). CONCLUSIONS With adequate third-tier training, a newly developed EUS program can achieve safe and accurate results of EUS-FNA of the pancreas. The learning curve, however, needs to continue after the fellowship, because more procedures are needed for one to gain proficiency and efficiency with EUS-FNA.

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

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.

Agreement between rapid onsite and final cytologic interpretations of EUS-guided FNA specimens : Implications for the endosonographer and patient management

BACKGROUND:The practice of onsite cytology interpretation varies across endoscopic ultrasound (EUS) programs in the Untied States and Europe. The value, reliability, and agreement of rapid onsite evaluation (ROSE) compared with final interpretation and its impact on patient management remain largely unknown. We compared agreement between ROSE of EUS-FNA (endoscopic ultrasound-guided fine needle aspiration) specimens with final cytology interpretation and their respective operating characteristics.METHODS:We prospectively evaluated consecutive EUS-FNA specimens obtained by a single endosonographer in the presence of an attending cytopathologist (July 2000–November 2002). The “agreement” between ROSE and final cytology interpretation was assessed by the “kappa” statistic. The frequency and possible reasons for discrepancy between ROSE and final cytologic interpretation were determined.RESULTS:A total of 540 patients (median age 63 yr, 77% white) underwent EUS-FNAs of 656 lesions. These included lymph nodes (LNs, N = 248), solid pancreatic masses (SPMs, N = 229), cystic pancreatic masses (CPM, N = 57), mural lesions (41), bile duct/gallbladder (N = 28), liver (N = 17), mediastinum/lung (N = 17), adrenal (N = 15), spleen (N = 3), and kidney (N = 1). Data were available for onsite evaluation in 607 lesions. Intitial cytology was benign (N = 243), atypical (N = 23), suspicious (24), malignant (300), and indeterminate (N = 17). Out of the 243 benign lesions interpreted by onsite evaluation, five lesions (2.1%) were upgraded to be malignant or suspicious for malignancy on final cytology report. Of the 300 lesions initially reported malignant on ROSE, 294 (98%) remained malignant on the final cytology. There was an excellent agreement between ROSE and final cytologic evaluation (kappa = 84.0%, 95% CI 80.2–87.7), Compared with the true final status, accuracy for final interpretation was slightly higher than for ROSE but was not statistically significant (95.8% vs 93.9%). Scant cellularity remained the most frequent reason for discrepancy, accounting for 21 of 51 discrepancies (41%). Other reasons for discrepancy included: cases requiring an intradepartmental consultation (22%), cases requiring ancillary studies (12%), intra-observer variability (10%), and challenging diagnosis (10%). In three cases, (6%) we were unable to determine the possible reason for discrepancy.CONCLUSION:ROSE of EUS-FNA specimens is highly accurate compared with final cytologic evaluation. Because the diagnosis of malignancy rarely changes, informing our patients and their families and our referring physicians of a cancer diagnosis significantly reduces physician work load and expedites patient management. The majority of discrepancies are related to the nature of the lesion either because it sheds few cells, has challenging morphology, and/or requires additional ancillary studies.

Successful stenting in ductal disruption favorably impacts treatment outcomes in patients undergoing transmural drainage of peripancreatic fluid collections

Background and Aim:  The role of pancreatic duct (PD) stenting in patients undergoing endoscopic transmural drainage of peripancreatic fluid collection (PFC) remains unclear. The objective of this study is to evaluate the effect of PD stenting on treatment success in patients undergoing endoscopic transmural drainage of PFC.

Graded dilation technique for EUS-guided drainage of peripancreatic fluid collections: an assessment of outcomes and complications and technical proficiency (with video)

BACKGROUND Although the utility and safety of EUS and EUS-guided FNA is well known, there is a need for more data on outcomes and complications of EUS-guided drainage procedures. OBJECTIVE To evaluate the rates of technical success, treatment success, and complications of the graded dilation technique for performing EUS-guided drainage of peripancreatic fluid collections (PFCs) in a large cohort of patients. Also, the technical proficiency for performing EUS-guided drainage of PFCs was evaluated. DESIGN A prospective study of all patients undergoing EUS-guided drainage of PFC. SETTING A tertiary-referral center. INTERVENTIONS After passage of a 0.035-inch guidewire into the PFC by using a 19-gauge needle, graded dilation of the tract was sequentially performed by using a 4.5F ERCP cannula, a 10F ERCP inner guiding catheter, and an 8-mm balloon dilator. A transmural stent and/or drainage catheter was then deployed. MAIN OUTCOME MEASUREMENTS To evaluate the technical success, treatment success, and complications of the graded dilation technique. Technical proficiency was evaluated by comparing the procedural duration between the first 25 cases (group A), with a later cohort of patients (group B, n = 29) who underwent EUS-guided drainage of a single PFC. RESULTS Sixty patients (41 men; mean age 51 years [range 20-79 years], 6 multiple PFCs) underwent EUS-guided drainage of a PFC (types included 36 pseudocyst, 15 abscess, and 9 necrosis) over a 42-month period. The rates of technical and treatment success were 95% and 93%, respectively. A minor complication of stent migration was encountered in 1 of 60 patients (1.7%). There was no significant difference in patient or clinical characteristics between group A and B patients who were undergoing drainage of a single PFC. Although there was no significant difference in technical or treatment outcome, median procedural duration was significantly shorter for group B than for group A patients (25 vs 70 minutes; P < .001). Procedural duration for performing EUS-guided drainage of a single PFC was more likely to be <30 minutes in group B than in group A patients (crude odds ratio [OR] 18.8; P < .001), which remained significant (adjusted OR 11.8; P = .01), even after adjusting for patient age; serum albumin; type, location, and size of PFCs; drainage modality (stent vs stent plus drainage catheter); and site of endoscopic access for establishing drainage. CONCLUSIONS In this study, EUS-guided drainage of a PFC could be performed safely by using the graded dilation technique, with a successful outcome in a majority of patients. Technical proficiency, with regard to procedural duration, improved significantly after the first 25 cases.

Prospective Assessment of Diagnostic Utility and Complications of Endoscopic Ultrasound-Guided Fine Needle Aspiration

Background: It is currently unknown whether a newly developed endoscopic ultrasound (EUS) program can produce results similar to those of experienced EUS centers. We therefore prospectively evaluated the diagnostic accuracy and major complications of EUS-guided fine needle aspiration (EUS-FNA) in a newly developed EUS program. Methods: All procedures were performed by a single endosonographer in the presence of a cytopathologist. Reference standard for classification of final disease included: surgical resection, death from disease progression and repeat radiologic and/or clinical follow-up. Major complications were defined as oversedation, and those that resulted in a physician or emergency department visits, hospitalization, or death. Results: 540 patients (median age 63 years, 77% white) underwent EUS-FNAs of 656 lesions: lymph nodes (LNs, n = 248), solid pancreatic masses (SPMs, n = 229), cystic pancreatic masses (CPM, n = 57), mural lesions (n = 41), bile duct/gallbladder (n = 28), liver (n = 17), mediastinum/lung (n = 17), adrenal (n = 15), spleen (n = 3) and kidney (n = 1). SPMs and bile duct/gallbladder lesions were more likely to have suspicious/atypical cytology when compared to other lesions (8.7 vs. 4.6%; p = 0.04) and required more passes to achieve a tissue diagnosis (p < 0.001). The overall sensitivity, specificity, PPV, NPV and accuracy of EUS-FNA was 91.7, 97.1, 98.1, 87.7 and 93.8%, respectively. Six patients (1.1%) (95% CI 0.4–2.4) experienced a major complication. One patient died shortly after the procedure due to preexisting pulmonary embolus (0.18%). Conclusion: EUS-FNA is highly accurate and safe in sampling a variety of peri-intestinal organs and lymph nodes. With adequate third-tier training, a newly developed program can produce results similar to those from expert EUS centers.

A large single-center experience of EUS-guided FNA of the left and right adrenal glands: diagnostic utility and impact on patient management

BACKGROUND EUS-guided FNA of the left and right adrenals has been described, but data are very limited. OBJECTIVES Our primary objective was to determine the impact of the diagnostic utility of EUS-guided FNA of adrenal glands on patient management. Our secondary objective was to determine predictors of malignant adrenal involvement. STUDY DESIGN Observational study. SETTING Tertiary referral center. PATIENTS Patients with enlarged adrenal(s) on abdominal imaging underwent EUS-guided FNA. The left adrenal (n = 54) was sampled via the transgastric approach and the right adrenal (n = 5) via a transduodenal approach. RESULTS Fifty-nine patients (63% men, median age 65 years) were evaluated. The median adrenal gland size was 25 x 17 mm. Adrenal tissue adequate for interpretation was obtained in all of the patients. EUS-guided FNA confirmed malignancy in 22 (37%) patients. Based on size (> or =30 mm) alone, EUS had an accuracy of 68%. Patients with malignant cytology had higher standard uptake value scores on positron-emission tomography compared with patients with benign adrenal masses (P < .001). Malignant masses were more likely to have an altered adrenal gland shape compared with benign masses (crude odds ratio [OR] 12.0; P < .001). On multivariable analysis, altered adrenal gland shape was a significant predictor of malignancy (adjusted OR 7.94; P = .015), whereas a size of 30 mm or larger (adjusted OR 1.30; P = .774) and hypoechoic nature (adjusted OR 12.05; P = .148) were not. All patients except 2 with malignant cytology were treated with systemic therapy without the need for additional invasive biopsies or surgery. No immediate complications were encountered. LIMITATIONS Lack of surgical criterion standard; 1 experienced endosonographer. CONCLUSIONS EUS-guided FNA of the adrenal glands is a minimally invasive and safe approach that documents or excludes malignant involvement. EUS-guided FNA should be the first next test to evaluate enlarged adrenal glands because it directs therapy and affects patient management.

Cervical esophageal perforations at the time of endoscopic ultrasound: a prospective evaluation of frequency, outcomes, and patient management.

OBJECTIVES:With the exception of one retrospective survey, there are currently no prospectively published data about the frequency of cervical esophageal perforation at the time of endoscopic ultrasound (CEP-EUS). We prospectively investigated the frequency of CEP-EUS and the outcomes and management of patients sustaining CEP-EUS.METHODS:All patients that underwent upper EUS by a single experienced endosonographer over a 7-year period were enrolled. All indications and immediate complications encountered, the baseline demographics, indication of the procedures, surgical interventions, length of hospital stay, and the final outcomes of the patients were prospectively recorded.RESULTS:A total of 5,225 EUS procedures were performed. Lower gastrointestinal tract EUS procedures (n=331) were excluded from the analysis, and thus 4,894 upper EUSs constitute this study. The mean age of the patients was 59.7 years (s.d. 14.3 years); 54% patients were men and 79% were white. Indications for EUS included pancreaticobiliary (58%), esophageal (14%), mediastinal (14%), gastric (9%), celiac blocks (1%), and other (4%). Of 4,894 patients, 3 (0.06%, exact 95% confidence interval: 0.01–0.18) suffered CEP-EUS. The curvilinear echoendoscope was used in all three patients. All patients were octogenarians and women. All perforations were suspected at the time of intubation. Esophagogram confirmed contained perforation in all patients. All patients were immediately admitted and underwent surgical repair with a neck incision and recovered completely. The length of hospital stay was 6, 11, and 23 days respectively. All patients resumed swallowing without complications. One patient died from progressive pancreatic cancer 6 months after Whipples procedure. The two other patients remained alive and well 12 and 22 months after the procedure.CONCLUSIONS:CEP-EUS is rare but a potentially devastating event for the patient and the treating physician. Although rare, the incidence is 2- to 3-fold higher than what has been reported in the survey literature. Early recognition and treatment is crucial for prompt intervention and complete recovery from CEP-EUS. These data can be used by endosonographers to counsel their patients about frequency, management, and outcomes of CEP-EUS.

Prospective randomized trial evaluating ketamine for advanced endoscopic procedures in difficult to sedate patients.

Background Adequate patient sedation is mandatory for advanced endoscopic procedures such as ERCP and EUS.