EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial).

BACKGROUND & AIMS: Several studies have compared primary endoscopic ultrasound (EUS)-guided biliary drainage to endoscopic retrograde cholangiopancreatography (ERCP) with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study. METHODS: This was a multicenter international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MDBO were recruited. Patients were randomly allocated to receive EUS-guided choledocho-duodenostomy (ECDS) or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, reintervention rates, and overall survival. RESULTS: Between January 2017 and February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P = .52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < .001), whereas clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P = .559). The median (interquartile range) procedural time was significantly shorter in the ECDS group (ECDS 10 [5.75-18] vs ERCP 25 [14-40] minutes, P < .001). The rate of 30-day adverse events (P = 1) and 30-day mortality (P = .53) were similar. CONCLUSION: Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical success and shorter procedural time then ERCP. Primary ECDS may be preferred when difficult ERCPs are anticipated. This study was registered to Clinicaltrials.gov NCT03000855.

Upper gastrointestinal endoscopy in the surgically altered patient.

As management of upper gastrointestinal malignancies improves, and with popularization of bariatric surgery, endoscopists are likely to meet patients with altered upper gastrointestinal anatomy. Short-term, the surgery can cause complications like bleeding, leaks, and fistulas, and longer-term problems such as intestinal or biliary anastomotic strictures or biliary stones can arise, all necessitating endoscopy. In addition, the usual upper gastrointestinal pathologies can also still occur. These patients pose unique challenges. To proceed, understanding the new layout of the upper gastrointestinal tract is essential. The endoscopist, armed with a clear plan for navigation, can readily diagnose and manage most commonly occurring conditions, such as marginal ulcers and proximal anastomotic strictures with standard endoscopic instruments. With complex reconstructions involving long segments of small bowel, such as Roux-en-Y gastric bypass, utilization of balloon-assisted enteroscopy may be necessary, mandating modification of procedures such as endoscopic retrograde cholangiopancreatography. Successful endoscopic management of patients with altered anatomy will require prior planning and preparation to ensure the appropriate equipment, setting, and skill set is provided.

Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial.

BACKGROUND & AIMS: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients. METHODS: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. RESULTS: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred. CONCLUSIONS: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.).

Endoscopic bariatric therapies for obesity: a review.

▪ Obesity is reaching pandemic proportions globally, with overweight or obesity affecting at least two-thirds of Australian adults. ▪ Bariatric surgery is an effective weight loss strategy but is constrained by high resource requirements and low patient acceptance. ▪ Multiple endoscopic bariatric therapies have matured, with well established and favourable safety and efficacy profiles in multiple randomised controlled trials (RCTs), and are best used within a multidisciplinary setting as an adjuvant to lifestyle intervention. ▪ Three types of intragastric balloon are currently in use in Australia offering average total weight loss ranging from 10% to 18%, with others available internationally. ▪ Endoscopic sleeve gastroplasty produces average total weight loss of 15-20% with low rates of severe complications, with RCT data anticipated in December 2021. ▪Bariatric and metabolic endoscopy is rapidly evolving, with many novel, promising therapies currently under investigation.

Drainage of pancreatic fluid collections using a lumen-apposing metal stent with an electrocautery-enhanced delivery system.

BACKGROUND AND AIM: Our aim was to evaluate the efficacy and safety of a lumen-apposing metal stent with an electrocautery-enhanced delivery system (EDS-LAMS) for endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) in regular clinical practice. METHODS: A retrospective and subsequent prospective analysis was undertaken of all patients who underwent EUS-guided drainage of their PFCs using the EDS-LAMS at 17 tertiary therapeutic endoscopy centers. RESULTS: Two hundred eight cases of EDS-LAMS deployment were attempted in 202 patients (mean age 52.9 years) at time of evaluation. Ninety-seven patients had pancreatic pseudocysts (PPs), 75 walled-off pancreatic necrosis (WOPN), 10 acute peripancreatic fluid collections (APFCs), 6 acute necrotic collections (ANCs), and 14 postoperative collections (POCs). Procedural technical success was achieved in 202/208 cases (97.1%). Maldeployment occurred in 7/208 cases (3.4%). Clinical success was achieved in 142/160 (88.8%) patients (PP 90%, WOPN 85.2%, APFC 100%, ANC 75%, POC 100%). Delayed adverse events included stent migration in 15/202 (7.4%), stent occlusion and infection in 16/202 (7.9%), major bleeding in 4/202 (2%), and buried EDS-LAMS in 2/202 (1%). PFC recurrence occurred in 13/142 (9.2%) patients; 9/202 (4.5%) required surgical or radiological intervention for PFC management after EDS-LAMS insertion. CONCLUSIONS: This large international multicenter study evaluating the EDS-LAMS for drainage of PFCs in routine clinical practice suggests that the EDS-LAMS are safe and effective for drainage of all types of PFCs; however, further endoscopic therapy is often required for WOPN. Major bleeding was a rare complication in our cohort.

Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry.

BACKGROUND: Peroral cholangioscopy (POCS) of indeterminate biliary strictures aims to achieve a diagnosis through visual examination and/or by obtaining targeted biopsies under direct visualization. In this large, prospective, multinational, real-life experience of POCS-guided evaluation of indeterminate biliary strictures, we evaluated the performance of POCS in this difficult-to-manage patient population. METHODS: This prospective registry enrolled patients, with indeterminate biliary strictures across 20 centers in Asia, the Middle East, and Africa. The primary end points were the ability to visualize the lesion, obtain histological sampling when intended, and an assessment of the diagnostic accuracy of POCS for malignant strictures. Patients were followed for 6 months after POCS or until a definitive malignant diagnosis was made, whichever occurred first. RESULTS: 289 patients underwent 290 POCS procedures with intent to biopsy in 182 cases. The stricture/filling defect was successfully visualized in 286/290 (98.6 %), providing a visual diagnostic impression in 253/290 (87.2 %) and obtaining adequate biopsies in 169/182 (92.9 %). Procedure-related adverse events occurred in 5/289 patients (1.7 %). POCS influenced patient management principally by elucidating filling defects or the causes of bile duct stricture or dilation. The visual impression of malignancy showed 86.7 % sensitivity, 71.2 % specificity, 65.8 % positive and 89.4 % negative predictive value, and 77.2 % overall accuracy compared with final diagnosis. Histological POCS-guided samples showed 75.3 % sensitivity, 100 % specificity, 100 % positive and 77.1 % negative predictive value, and 86.5 % overall accuracy. CONCLUSION: In this large, real-life, prospective series, POCS was demonstrated to be an effective and safe intervention guiding the management of patients with indeterminate biliary strictures.

Small bowel strictures.

PURPOSE OF REVIEW: Strictures of the small bowel are an underdiagnosed entity with significant morbidity because of obstruction and risk of perforation and penetrating disease. RECENT FINDINGS: Recent advances in imaging, enteroscopy, and therapeutic advances particularly in Crohn's disease have enabled gastroenterologists to target and individualize management of small bowel strictures, preventing untimely surgery and complications. SUMMARY: All patients with obstructive symptoms, suspected small bowel disease, and negative panendoscopy should be evaluated for small intestinal strictures with cross-sectional imaging and considered for capsule endoscopy. Furthermore, the role of device-assisted enteroscopy, initially employed as a diagnostic tool, has evolved into triaging and delivering further medical and interventional treatments.

Success and complications of an intra-ductal fully covered self-expanding metal stent (ID-FCSEMS) to treat anastomotic biliary strictures (AS) after orthotopic liver transplantation (OLT).

BACKGROUND: Anastomotic biliary strictures (AS) after orthotopic liver transplantation (OLT) belong to the most common biliary complications and cause the biggest morbidity burden after OLT. Metal stents for benign biliary strictures are gaining acceptance with many published series. Traditional metal stent designs seem to have poor durability in AS after OLT. Novel intra-ductal stents are showing promise in these strictures. As a result, we designed a special stent with an antimigration waist and a short stent length with a long removal string that rests in the duodenum for easy removal. PATIENTS AND METHODS: This is a retrospective multi-centre Australian study of AS after OLT treated with a novel intra-ductal fully covered self-expanding metal stent. From August 2008 to October 2014, records from three liver transplant centres were reviewed. RESULTS: Totally 36 ID-FCSEMS were inserted in 31 cases to treat an AS after OLT. The mean age of the patients was 56 years, and 61 % were male. The mean time of AS presentation after OLT was 20.3 months. Eight out of our 31 patients were previously treated using multiple plastic stenting over time without any success. Treatment with the ID-FCSEMS was performed with an average treatment time of 3.8 months. Stricture resolution was achieved in 100 %. All attempted stents removals were successful without any difficulty. Complications were reported in 6.5 %. It was pleasing that only one case of stent migration (2.8 %) was seen. Follow-up showed seven cases of AS recurrence (24.1 %), and all were treated successfully with repeat ERCP and stenting (some metal, some plastic). CONCLUSION: This novel ID-FCSEMS has a high clinical success and low complication rate, and in particular, there was only one case of stent migration. As a result, this stent type is preferred to traditional metal stents for treating AS after OLT.

Predictors of success for double balloon-assisted endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y anastomosis.

BACKGROUND AND AIM: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with roux-en-Y anastomosis (REYA) is challenging. Use of double balloon enteroscope-assisted ERCP (DBE-ERCP) has been successful. We aim to determine predictors of successful biliary cannulation with DBE-ERCP in patients with REYA. METHODS: We retrospectively studied patients with REYA who had DBE-ERCP between 2009 and 2015. RESULTS: 86 DBE-ERCP were done on 52 patients. Patients had REYA for liver transplant (n = 26), gastrojejunostomy (n = 9), previous bile duct injury (n = 9), biliary atresia (n = 2) and other (n = 6). The biliary-enteric anastomosis was reached in 76% and cholangiogram was successful in 70%. Highest success rates were in patients with previous bile duct injury (94%) or gastrojejunostomy (89%). Post-transplant patients had intermediate success (64%). Patients with redo surgery (46%) and childhood surgery (38%), especially Kasai procedure (20%), had low success. Patients with previous bile duct injury were more likely to succeed (94% vs 63%, P = 0.010). Those more likely to fail were patients with childhood surgery (38% vs 73%, P = 0.037), biliary atresia (20% vs 73%, P = 0.013) and second operation post-transplant (25% vs 70%, P = 0.046). CONCLUSION: Indication for REYA impacts on successful biliary cannulation in patients undergoing DBE-ERCP. The procedure is most successful in non-liver transplant adult surgery and post-transplant patients without a second operation. It is least successful in patients with surgically corrected biliary atresia and post-transplant patients with second operation. Alternative methods of biliary access should be considered in these patients.

Update on therapeutic interventions for the management of achalasia.

Achalasia is a primary esophageal motility disorder. It is the absence of peristalsis in the esophageal body and inability of the lower esophageal sphincter to relax, which characterizes this rare condition. Its features typically include dysphagia, regurgitation, chest pain, and weight loss. The ultimate goal in treating achalasia is to relieve the patient's symptoms, improve esophageal emptying, and prevent further dilatation of the esophagus. Current treatment modalities targeted at achalasia include pharmacological therapy, endoscopic therapy, and surgery. This review focuses on the current therapeutic options and explores the role of peroral endoscopic myotomy in the management armamentarium.

A prospective dual-center proof-of-principle study evaluating the incremental benefit of narrow-band imaging with a fixed zoom function in real-time prediction of polyp histology. Can we resect and discard?

BACKGROUND: Advancements in endoscopic technology have increased the ability to distinguish neoplastic polyps during colonoscopy. If a minimum accuracy can be achieved, then a resect-and-discard model can be implemented, although studies to date have demonstrated limited success, especially in the assessment of serrated polyps. OBJECTIVE: To perform a proof-of-principle study assessing the accuracy of narrow-band imaging with near focus in predicting polyp histology including serrated polyps and to determine whether the minimum requirements can be achieved for a resect-and-discard policy. DESIGN: Dual-center, prospective case series. SETTING: Two tertiary-care referral endoscopic centers in Australia. PATIENTS: Two hundred consecutive patients undergoing colonoscopy for routine indications were recruited. INTERVENTIONS: Any polyps identified were assessed by using standard white light followed by narrow-band imaging with near focus for Kudo pit patterns and modified Sano capillary patterns. Based on this assessment and the macroscopic appearance, the polyp histology was predicted and subsequently compared with histopathology results. MAIN OUTCOME MEASUREMENTS: Correlation in postpolypectomy surveillance intervals between endoscopic and pathologic assessments as well as negative predictive value for rectosigmoid hyperplastic polyps. RESULTS: There was a 96% agreement for surveillance intervals between endoscopic assessment and histology by using the American Society for Gastrointestinal Endoscopy guidelines. There was a 96% negative predictive value in assessing rectosigmoid hyperplastic polyps. LIMITATIONS: Because this was a proof-of-principle study, there was no control arm, and there were small numbers, especially in assessing subgroups. The results have limited generalizability with the training requirements for polyp recognition, with confidence to be determined. CONCLUSION: Narrow-band imaging with near focus can predict polyp histology (including serrated polyps) accurately in the hands of trained endoscopists. Further studies with larger numbers are required to further validate this practice.

Management of pancreatic collections with a novel endoscopically placed fully covered self-expandable metal stent: a national experience (with videos).

BACKGROUND: Recent medical literature on novel lumen-apposing stents for the treatment of pancreatic fluid collections (PFCs) is limited by small numbers, solo operators, and single-center experience. OBJECTIVE: To evaluate a recently developed lumen-apposing, fully covered self-expandable metal stent (FCSEMS) in the management of PFCs. DESIGN: Retrospective case series. SETTING: Thirteen tertiary and private health care centers across Australia. PATIENTS: Forty-seven patients (median age 51 years) who underwent endoscopic management of PFCs. INTERVENTION: Insertion of FCSEMS after PFC puncture under EUS guidance. A subgroup of 9 patients underwent direct endoscopic necrosectomy. MAIN OUTCOME MEASUREMENTS: Technical and clinical success rate, adverse event rate. RESULTS: The technical success rate was 53 of 54 patients (98.1%), and the initial clinical success rate was 36 of 47 (76.6%), which was sustained for more than 6 months in 34 of 36 (94.4%). Early adverse events included 4 cases (7.4%) of stent migration during direct endoscopic necrosectomy, 4 cases (7.4%) of sepsis, 1 case (1.9%) of bleeding, and 1 case (1.9%) of stent migration into the fistula tract. Late adverse events were 6 (11.1%) spontaneous stent migrations, 3 (5.6%) recurrent stent occlusions, 3 (5.6%) tissue ingrowth/overgrowth, and 2 (3.7%) bleeding into PFC. The majority of stents inserted (48 of 54, 88.9%) and removed (31 of 35, 88.6%) in our study were described by the operator as superior to pigtail stents with regard to ease of use. LIMITATIONS: Retrospective study. CONCLUSION: Although FCSEMSs are technically easier to insert and remove compared with traditional pigtail stents, there are significant limitations to the widespread use of FCSEMSs in the management of PFCs. These include cost, adverse events, and lower-than-expected resolution rates.

Outcomes of patients with hepaticojejunostomy anastomotic strictures undergoing endoscopic and percutaneous treatment.

Background and study aims The increase in hepaticojejunostomies has led to an increase in benign strictures of the anastomosis. Double balloon enteroscopy-assisted ERCP (DBE-ERCP) and percutaneous transhepatic biliary drainage (PTBD) are treatment options; however, there is lack of long-term outcomes, with no consensus on management. We performed a retrospective study assessing the outcomes of patients referred for endoscopic management of hepaticojejunostomy anastomotic strictures (HJAS). Patients and methods All consecutive patients at a tertiary institution underwent endoscopic intervention for suspected HJAS between 2009 and 2021 were enrolled. Results Eighty-two subjects underwent DBE-ERCP for suspected HJAS. The technical success rate was 77 % (63/82). HJAS was confirmed in 41 patients. The clinical success rate for DBE-ERCP ± PTBD was 71 % (29/41). DBE-ERCP alone achieved clinical success in 49 % of patients (20/41). PTBD was required in 49 % (20/41). Dual therapy was required in 22 % (9/41). Those with liver transplant had less technical success compared to other surgeries (72.1 % vs 82.1 % P  = 0.29), less clinical success with DBE-ERCP alone (40 % vs 62.5 % P  = 0.16) and required more PTBD (56 % vs 37.5 % P  = 0.25). All those with ischemic biliopathy (n = 9) required PTBD for clinical success, required more DBE-ERCP (4.4 vs 2.0, P = 0.004), more PTBD (4.7 vs 0.3, P  < 0.0001), longer treatment duration (181.6 vs 99.5 days P  = 0.12), and had higher rates of recurrence (55.6 % vs 30.3 % P  = 0.18) compared to those with HJAS alone. Liver transplant was the leading cause of ischemic biliopathy (89 %). The overall adverse event rate was 7 %. Conclusions DBE-ERCP is an effective diagnostic and therapeutic tool in those with altered gastrointestinal anatomy and is associated with low complication rates.

Meta-analysis of narrow-band imaging versus conventional colonoscopy for adenoma detection.

BACKGROUND: At colonoscopy, missed adenomas have been well documented at approximately 22%. The challenge is in reducing this miss rate. Narrow-band imaging (NBI) has been extensively evaluated in prospective, randomized, controlled studies for polyp detection. Sample-size calculations show us that these studies may be underpowered, and hence a meta-analysis is required. OBJECTIVE: Our aim was to determine whether use of NBI enhances the detection of adenomas. DESIGN: Meta-analyses were conducted of 7 studies using NBI for adenoma detection rate. MEDLINE, Embase, PubMed, and Cochrane databases were searched by using a combination of the following terms: "colonoscopy," "NBI," and "electronic chromoendoscopy." PATIENTS: There was a total of 2936 patients in the NBI studies. INTERVENTIONS: Prospective, randomized trials of NBI versus standard white-light colonoscopy (WLC) were conducted. We excluded spray chromoendoscopy studies and studies of inflammatory bowel disease and polyposis syndromes. MAIN OUTCOME MEASUREMENTS: Adenoma and polyp detection rates and the number of polyps and adenomas detected per person. RESULTS: There was no statistically significant difference in the overall adenoma detection rate with the use of NBI or WLC (36% vs 34%; P = .413 [relative risk 1.06; 95% CI, 0.97-1.16]), and there was no statistically significant difference in polyp detection rate by using NBI or WLC (37% vs 35%; P = .289 [relative risk 1.22; 95% CI, 0.85-1.76]). When the number of adenomas and polyps per patient was analyzed, no significant difference was found between NBI and WLC (0.645 vs 0.59; P = .105 and 0.373 vs 0.348; P = .139 [weighted mean difference 0.19; 95% CI, ∞0.06 to 0.44], respectively). LIMITATION: Variability in NBI studies can reduce the accuracy of this analysis. CONCLUSIONS: NBI did not increase adenoma or polyp detection rates.

SINGLE-01: a randomized, controlled trial comparing the efficacy and depth of insertion of single- and double-balloon enteroscopy by using a novel method to determine insertion depth.

BACKGROUND: Single-balloon enteroscopy (SBE) was introduced as an alternative to double-balloon enteroscopy (DBE) for the investigation and management of small-bowel conditions. To date, there is only 1 randomized, controlled trial comparing SBE and DBE in a Western population. OBJECTIVE: To compare the 2 instruments in a Western population to assess for differences in clinical outcomes and insertion depth (ID). A novel method to determine ID by counting folds on withdrawal was used. DESIGN: Multicenter, randomized, controlled trial. SETTING: University hospitals in Melbourne and Sydney, Australia. PATIENTS: Patients with suspected or proven small-bowel disease. INTERVENTIONS: SBE and DBE. MAIN OUTCOME MEASUREMENT: The primary endpoint was diagnostic yield (DY). Secondary endpoints were therapeutic yield (TY), procedure times, and ID. An intention-to-treat analysis was performed. RESULTS: A total of 116 patients were screened, and 107 patients were enrolled between July 2008 and June 2010, in whom 119 procedures were undertaken (53 SBEs and 66 DBEs). DY was 57% for SBE and 53% for DBE (P = .697). TY was 32% for SBE and 26% for DBE (P = .490). The median enteroscopy times were identical for SBE and DBE at 60 minutes. The mean ID by the fold-counting method for antegrade procedures was 201.1 folds for SBE and 258.6 folds for DBE (P = .046). After multiple comparisons adjustment, this difference did not reach statistical significance. Mean IDs by using the visual estimation method for SBE and DBE were, respectively, 72.1 cm and 75.2 cm (P = .835) for retrograde procedures and 203.8 cm and 234.1 cm (P = .176) for antegrade procedures. LIMITATIONS: Unable to reach target sample size, mostly single-center recruitment, novel method to determine ID, which requires further validation. CONCLUSIONS: SBE has DY, TY, and procedure times similar to those of DBE. There were no statistically significant differences in ID between SBE and DBE. By using the fold-counting method for antegrade procedures, the estimated IDs for SBE and DBE were 201.1 folds versus 258.6 folds (P = .046; P = not significant after adjustment for multiple comparisons). ( CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12609000917235.).

A prospective multicenter evaluation of a new side-port endoscopic ultrasound-fine-needle aspiration in solid upper gastrointestinal lesions.

BACKGROUND AND STUDY AIMS: Diagnostic yield of endoscopic ultrasound (EUS)-fine-needle aspiration (FNA) varies depending on the equipment used and the site targeted. Multiple needle passes are usually required to obtain a diagnosis. A new needle incorporating a side-port carries a theoretical advantage regarding acquisition of cytological material. The aim of the study was to demonstrate the safety and efficacy of the Olympus side-port needle in solid upper gastrointestinal indications. PATIENTS AND METHODS: A prospective multicenter evaluation of patients referred for EUS-FNA for solid lesions was performed across six tertiary gastroenterology referral centers in four capital cities in Australia. The main outcome measures include cytological diagnosis, number of needle passes required for diagnosis and complication rates. RESULTS: Thirty patients (17 men; 13 women) with a mean age of 67.5 years were studied. Indications included pancreatic or biliary mass in 24 patients, retroperitoneal or periduodenal mass in 2, enlarged lymph node in 2, a gastric submucosal tumor in 1 and a subcarinal mass in 1. The mean size of the lesions was 3.47 cm (range, 0.5-8 cm). All but one case had a diagnosis made (96.7%). The mean number of passes required to reach a diagnosis was 1.7. In neoplastic lesions the diagnosis was made with a mean of 1.6 passes. No complications were encountered. CONCLUSIONS: The new EUS-FNA needle with side port appears effective and safe in solid upper gastrointestinal EUS-FNA indications.