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Mo1423 Preliminary Data From the First Italian Experience With a New Universal Needle Delivery System for EUS-Guided FNA: a Randomized Clinical Trial Comparing the 25G and 22G Needle in the EUS-FNA of Solid Lesions
Abstracts
Mo1422 Interventional EUS Using the Flexible 19-Gauge EUS-FNA Needle: an International Multicenter Experience in 125 Patients Vivek Kumbhari*1, Irene PeñAs2, Carlos De La Serna2, Alan Tieu1, Manie Juneja3, Fuad Maufa4, Nadim Haddad4, Sandeep Krishnan5, Susana Gonzalez5, Renny Peter6, Payal Saxena1, Christopher J. Dimaio5, Jonathan Buscaglia7, Manuel Perez-Miranda2, Mouen Khashab1 1 Division of Gastroenterology and Hepatology.Department of Medicine., Johns Hopkins Hospital, Baltimore, MD; 2Endoscopy Unit. Department of Gastroenterology, Hospital Universitario Río Hortega, Valladolid, Spain; 3 Division of Geriatric Medicine. Department of Medicine, Georgetown University Medical Center, Washington, DC; 4Division of Gastroenterology and Hepatology. Department of Medicine, Georgetown University Medical Center, Washington, DC; 5Division of Gastroenterology.Department of Medicine., Mount Sinai School of Medicine, New York, NY; 6Department of Internal Medicine, Stony Brook School of Medicine, Stony Brook, NY; 7DIvision of Gastroenterology and Hepatology. Department of Medicine, Stony Brook School of Medicine, Stony Brook, NY Background: The 19g EUS needle is the needle of choice when performing interventional procedures as it allows easy passage of a guidewire and rapid injection of solution. However, due to its rigidity, access with the standard 19-gauge needle is often difficult when the echoendoscope is in a long or angulated position, such as the duodenum. A needle made of nitinol (Expect 19 Flex, Boston Scientific, Natick, MA) has been developed with enhanced flexibility. This needle has been shown to be successful in tissue acquisition through a transduodenal approach though it is not known if it will aid in interventional EUS. Aims: To evaluate the efficacy and safety of the flexible 19-gauge needle in performing interventional EUS procedures. Methods: This was an international multicenter retrospective analysis of consecutive interventional EUS procedures which utilized the flexible 19g needle for a variety of clinical indications. Patient records from five tertiary-care centers (4 US, 1 European) were abstracted and entered into a pre-defined database. Outcomes included needle specific technical success (successful needle puncture and adequate insertion of accessory or solution), procedural technical success, and clinical success at long term follow up. Complications specifically attributable to needle insertion as well as all cause complications were recorded. An analysis was performed to determine if there was any difference in success and complication rates between transgastric and transduodenal access. Results: A total of 125 patients (mean age 66 yrs, 45.6% female) underwent 125 interventional EUS procedures between July 2012 and October 2013 (table 1). Malignant etiology was present in 51.2% of patients and the majority (86%) of the procedures were drainage in nature. EUS-guided biliary drainage (54.4%) was the most common indication followed by pancreatic pseudocyst drainage (23.2%). In the entire cohort, needle specific technical success occurred in 94.4% and procedural technical success occurred in 84.8% of cases. Complications specifically attributable to needle insertion occurred in 10.6% and the overall complication rate was 21.3% (infection being the most common). Clinical success occurred in 75.9% at a mean duration of follow up of 3.5 months. Outcomes by site of needle puncture (table 2): there was no difference in needle specific technical success or clinical success between the transgastric and trasnduodenal route. However, procedural technical success was significantly higher with transgastric access (90.00% vs. 73.8%, pZ0.046). Conclusions: This large multicenter study suggests that the flexible 19g needle was effective for use in interventional EUS procedures with an acceptable complication rate. The flexible nature of the needle allows similar procedural success between transgastric and transduodenal routes.
Characteristics of all the interventional EUS procedures Number, n Age (yr) mean (SD) Female,n(%) Interventional EUS procedure Type, n (%) Biliary obstruction Pancreaticpseudocyst Celiac plexus block/neurolysis Gastric variceal embolization/coiling Gallbladder drainage Fiducial placement Pancreatic duct obstruction Rectal varices Others Site of needle puncture n(%) Gastric Duodenal Esophageal
125 66.4(15.87) 57 (45.6)
68 29 6 5 5 3 1 1 7
(54.4) (23.2) (4.8) (4) (4) (2.4) (0.8) (0.8) (5.6)
70 (56) 42 (33.6) 5 (4)
AB324 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014
Number, n
125
Jejunal Colonic Procedure-related Outcomes Average procedure time (mins) (SD) Average number of passes to gain access (SD) Salvage needle usage (%)
6 (4.8) 2 (1.6) 63.18 (30.31) 1.19 (0.48) 3.20
Outcomes of transgastric versus transduodenal approach Route of Access
Interventional EUS cases Technical Success (needle specific) (%) Technical Success (procedure overall) (%) Clinical Success (%) Complications (needle specific) (%) Complications (overall procedure) (%)
Transgastric n (%) 70 (56)
Transduodenal, n (%) 42 (33.6)
p value
67 (95.71)
40 (95.24)
1.00
63 (90)
31 (73.81)
0.046
47 (75.81) 6 (8.7)
29 (74.36) 6 (14.3)
1.00 0.69
13 (19.12)
12 (29.27)
0.33
Mo1423 Preliminary Data From the First Italian Experience With a New Universal Needle Delivery System for EUS-Guided FNA: a Randomized Clinical Trial Comparing the 25G and 22G Needle in the EUS-FNA of Solid Lesions Silvia Carrara*1, Andrea Anderloni1, Manol Jovani1, Daoud Rahal2, Luca Di Tommaso2, Davide Federico2, Alessandro Repici1 1 Gastroenterology-Digestive Endoscopy Service, Humanitas Research Hospital, Rozzano, Italy; 2Pathology Unit, Humanitas Research Hospital, Rozzano, Italy Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a safe and effective technique for obtaining samples from the GI tumors and lymphnodes. Available needles include 25G, 22G and 19G. A recently developed needle allows for interchangeability of all needle sizes through a universal delivery system (BNX system). Aims: The primary endpoint of this prospective, randomized, clinical trial was the percentage of cases in which an adequate sample was obtained from solid lesions. Secondary aims were the comparison between the 25G and 22G needle (BNX), the ease of needle pass, needle malfunction, number of passes, number of crossovers to the other needle size, major complications. Materials and Methods: Consecutive patients referred for EUS-FNA for solid masses were randomized to the 25G or to the 22G needle arms. Inclusion criteria: EUS appearance of a solid lesions, age O18 yrs, informed consent. EUS was performed with a linear echoendoscope. Once the lesion had been identified and found appropriate for sampling, the patients were randomly selected to the 22G or 25G needle. Crossover to the other size of needle was allowed when the endoscopist experienced difficulties in puncturing the mass, or when the material was not adequate after 2 passes. Results: Forty patients were enrolled from Aug to Nov 2013 (25M; 15F), mean age 68 years (range 36-86): 29 pancreatic masses, 9 lymphnodes and 2 parietal lesions. Twenty patients were randomized to the 22G needle arm: in 6 cases (30%) a crossover to the 25G was done because of the hardness of the tumor. Twenty pts were randomized to the 25G needle arm: in 6 cases (30%) a crossover to the 22G was asked by the pathologist in order to obtain more material for immunohistochemistry (neuroendocrine tumors or metastasis to nodes). The mean of needle passes was 2.2 (1.08 SD) per lesion. In 19 cases the aspirate was both smeared for cytological examination and put into formalin for histology. Final diagnosis was confirmed by surgical resection or radiological follow up. Overall adequacy was 95%. The 2 inadequate FNA (a gastric GIST and a suspected pancreatic serous cystadenoma with pseudo-solid appearance) were done with a 22G needle. Both lesions were hypervascularized. Sensitivity and accuracy were respectively 92% and 93% for the 25G needle and 90% and 90% for the 22G needle. In 2 cases resistance was felt with the 22G needle advancement inside the sheath. No major complications were observed. Conclusions: The new universal needle delivery system showed a high adequacy of the sample. No significant differences were observed between needle sizes.
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Mo1422 Interventional EUS Using the Flexible 19-Gauge EUS-FNA Needle: an International Multicenter Experience in 125 Patients Vivek Kumbhari*1, Irene PeñAs2, Carlos De La Serna2, Alan Tieu1, Manie Juneja3, Fuad Maufa4, Nadim Haddad4, Sandeep Krishnan5, Susana Gonzalez5, Renny Peter6, Payal Saxena1, Christopher J. Dimaio5, Jonathan Buscaglia7, Manuel Perez-Miranda2, Mouen Khashab1 1 Division of Gastroenterology and Hepatology.Department of Medicine., Johns Hopkins Hospital, Baltimore, MD; 2Endoscopy Unit. Department of Gastroenterology, Hospital Universitario Río Hortega, Valladolid, Spain; 3 Division of Geriatric Medicine. Department of Medicine, Georgetown University Medical Center, Washington, DC; 4Division of Gastroenterology and Hepatology. Department of Medicine, Georgetown University Medical Center, Washington, DC; 5Division of Gastroenterology.Department of Medicine., Mount Sinai School of Medicine, New York, NY; 6Department of Internal Medicine, Stony Brook School of Medicine, Stony Brook, NY; 7DIvision of Gastroenterology and Hepatology. Department of Medicine, Stony Brook School of Medicine, Stony Brook, NY Background: The 19g EUS needle is the needle of choice when performing interventional procedures as it allows easy passage of a guidewire and rapid injection of solution. However, due to its rigidity, access with the standard 19-gauge needle is often difficult when the echoendoscope is in a long or angulated position, such as the duodenum. A needle made of nitinol (Expect 19 Flex, Boston Scientific, Natick, MA) has been developed with enhanced flexibility. This needle has been shown to be successful in tissue acquisition through a transduodenal approach though it is not known if it will aid in interventional EUS. Aims: To evaluate the efficacy and safety of the flexible 19-gauge needle in performing interventional EUS procedures. Methods: This was an international multicenter retrospective analysis of consecutive interventional EUS procedures which utilized the flexible 19g needle for a variety of clinical indications. Patient records from five tertiary-care centers (4 US, 1 European) were abstracted and entered into a pre-defined database. Outcomes included needle specific technical success (successful needle puncture and adequate insertion of accessory or solution), procedural technical success, and clinical success at long term follow up. Complications specifically attributable to needle insertion as well as all cause complications were recorded. An analysis was performed to determine if there was any difference in success and complication rates between transgastric and transduodenal access. Results: A total of 125 patients (mean age 66 yrs, 45.6% female) underwent 125 interventional EUS procedures between July 2012 and October 2013 (table 1). Malignant etiology was present in 51.2% of patients and the majority (86%) of the procedures were drainage in nature. EUS-guided biliary drainage (54.4%) was the most common indication followed by pancreatic pseudocyst drainage (23.2%). In the entire cohort, needle specific technical success occurred in 94.4% and procedural technical success occurred in 84.8% of cases. Complications specifically attributable to needle insertion occurred in 10.6% and the overall complication rate was 21.3% (infection being the most common). Clinical success occurred in 75.9% at a mean duration of follow up of 3.5 months. Outcomes by site of needle puncture (table 2): there was no difference in needle specific technical success or clinical success between the transgastric and trasnduodenal route. However, procedural technical success was significantly higher with transgastric access (90.00% vs. 73.8%, pZ0.046). Conclusions: This large multicenter study suggests that the flexible 19g needle was effective for use in interventional EUS procedures with an acceptable complication rate. The flexible nature of the needle allows similar procedural success between transgastric and transduodenal routes.
Characteristics of all the interventional EUS procedures Number, n Age (yr) mean (SD) Female,n(%) Interventional EUS procedure Type, n (%) Biliary obstruction Pancreaticpseudocyst Celiac plexus block/neurolysis Gastric variceal embolization/coiling Gallbladder drainage Fiducial placement Pancreatic duct obstruction Rectal varices Others Site of needle puncture n(%) Gastric Duodenal Esophageal
125 66.4(15.87) 57 (45.6)
68 29 6 5 5 3 1 1 7
(54.4) (23.2) (4.8) (4) (4) (2.4) (0.8) (0.8) (5.6)
70 (56) 42 (33.6) 5 (4)
AB324 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014
Number, n
125
Jejunal Colonic Procedure-related Outcomes Average procedure time (mins) (SD) Average number of passes to gain access (SD) Salvage needle usage (%)
6 (4.8) 2 (1.6) 63.18 (30.31) 1.19 (0.48) 3.20
Outcomes of transgastric versus transduodenal approach Route of Access
Interventional EUS cases Technical Success (needle specific) (%) Technical Success (procedure overall) (%) Clinical Success (%) Complications (needle specific) (%) Complications (overall procedure) (%)
Transgastric n (%) 70 (56)
Transduodenal, n (%) 42 (33.6)
p value
67 (95.71)
40 (95.24)
1.00
63 (90)
31 (73.81)
0.046
47 (75.81) 6 (8.7)
29 (74.36) 6 (14.3)
1.00 0.69
13 (19.12)
12 (29.27)
0.33
Mo1423 Preliminary Data From the First Italian Experience With a New Universal Needle Delivery System for EUS-Guided FNA: a Randomized Clinical Trial Comparing the 25G and 22G Needle in the EUS-FNA of Solid Lesions Silvia Carrara*1, Andrea Anderloni1, Manol Jovani1, Daoud Rahal2, Luca Di Tommaso2, Davide Federico2, Alessandro Repici1 1 Gastroenterology-Digestive Endoscopy Service, Humanitas Research Hospital, Rozzano, Italy; 2Pathology Unit, Humanitas Research Hospital, Rozzano, Italy Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a safe and effective technique for obtaining samples from the GI tumors and lymphnodes. Available needles include 25G, 22G and 19G. A recently developed needle allows for interchangeability of all needle sizes through a universal delivery system (BNX system). Aims: The primary endpoint of this prospective, randomized, clinical trial was the percentage of cases in which an adequate sample was obtained from solid lesions. Secondary aims were the comparison between the 25G and 22G needle (BNX), the ease of needle pass, needle malfunction, number of passes, number of crossovers to the other needle size, major complications. Materials and Methods: Consecutive patients referred for EUS-FNA for solid masses were randomized to the 25G or to the 22G needle arms. Inclusion criteria: EUS appearance of a solid lesions, age O18 yrs, informed consent. EUS was performed with a linear echoendoscope. Once the lesion had been identified and found appropriate for sampling, the patients were randomly selected to the 22G or 25G needle. Crossover to the other size of needle was allowed when the endoscopist experienced difficulties in puncturing the mass, or when the material was not adequate after 2 passes. Results: Forty patients were enrolled from Aug to Nov 2013 (25M; 15F), mean age 68 years (range 36-86): 29 pancreatic masses, 9 lymphnodes and 2 parietal lesions. Twenty patients were randomized to the 22G needle arm: in 6 cases (30%) a crossover to the 25G was done because of the hardness of the tumor. Twenty pts were randomized to the 25G needle arm: in 6 cases (30%) a crossover to the 22G was asked by the pathologist in order to obtain more material for immunohistochemistry (neuroendocrine tumors or metastasis to nodes). The mean of needle passes was 2.2 (1.08 SD) per lesion. In 19 cases the aspirate was both smeared for cytological examination and put into formalin for histology. Final diagnosis was confirmed by surgical resection or radiological follow up. Overall adequacy was 95%. The 2 inadequate FNA (a gastric GIST and a suspected pancreatic serous cystadenoma with pseudo-solid appearance) were done with a 22G needle. Both lesions were hypervascularized. Sensitivity and accuracy were respectively 92% and 93% for the 25G needle and 90% and 90% for the 22G needle. In 2 cases resistance was felt with the 22G needle advancement inside the sheath. No major complications were observed. Conclusions: The new universal needle delivery system showed a high adequacy of the sample. No significant differences were observed between needle sizes.
www.giejournal.org