Modification in 26-gauge Needle
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ABSTRACT:
SUBMITTER: Nahata V
PROVIDER: S-EPMC8061639 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and Objectives: Endoscopic ultrasound (EUS) fine needle biopsy (FNB) needles were designed to improve histologic yield, while maintaining the flexibility to permit ease of use. However, the diagnostic benefit of EUS-FNB needles as compared to the conventional fine needle aspiration (FNA) needles remains unclear. This study aimed to identify the diagnostic accuracy of combined needle use of a new 20-gauge ProCore FNB needle and a 25-gauge FNA needle. Methods: For this study, cases were selected in which both the 20-gauge ProCore FNB needle and the 25-gauge FNA needle were used during a single EUS procedure for sampling of a solid pancreatic mass, lymph node, or submucosal mass. Tissue acquisition was performed in the course of the ASPRO trial, a multicenter randomized study comparing the diagnostic value of 20-gauge ProCore FNB and 25-gauge FNA needles (ClinicalTrials.gov: NCT02167074). The protocol allowed additional sampling with the nonassigned needle, at the discretion of an endosonographer. Results: Of all 615 patients who were randomized for the ASPRO study, 74 were sampled with both needle types. In these combined needle cases, FNA was used first in 24 and ProCore FNB in 50 cases. Target lesions encompassed 39 solid pancreatic lesions, 18 submucosal masses, and 17 lymph nodes. Most pancreatic lesions were located in the head (25/39), lymph nodes were mainly located in the abdomen (15/18), and submucosal lesions were located in the stomach (8/20), esophagus (4/20), small intestines (3/20), and rectum (3/20). The main reason to use ProCore in addition to FNA was to collect more tissue for ancillary testing (79%). FNA was generally used in addition to ProCore to allow for on-site pathological assessment (76%). The regimen of FNA followed by ProCore resulted in 100% accuracy, while for ProCore followed by FNA, 88% was reached (P = 0.086). The type of target lesion, either pancreatic or nonpancreatic, did not affect the diagnostic accuracy of the two sampling regimens (odds ratio 1.2, 95% confidence interval 0.22–6.61, P = 0.834). Conclusion: FNA followed by ProCore FNB provides for a 100% diagnostic accuracy and tends to outperform ProCore FNB followed by FNA. Accuracy rates were independent of the type of target lesion.
| S-EPMC5569758 | biostudies-literature
Project description:To compare the aspiration needle (AN) and core biopsy needle (PC) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of abdominal masses.Consecutive patients referred for EUS-FNA were included in this prospective single-center trial. Each patient underwent a puncture of the lesion with both standard 22-gauge (G) AN (Echo Tip Ultra; Cook Medical, Bloomington, Indiana, United States) and the novel 22G PC (EchoTip ProCore; Cook Medical, Bloomington, Indiana, United States) in a randomized fashion; histology was attempted in the PC group only. The main study endpoint was the overall diagnostic accuracy, including the contribution of histology to the final diagnosis. Secondary outcome measures included material adequacy, number of needle passes, and complications.Fifty six consecutive patients (29 men; mean age 68 years) with pancreatic lesions (n = 38), lymphadenopathy (n = 13), submucosal tumors (n = 4), or others lesions (n = 1) underwent EUS-FNA using both of the needles in a randomized order. AN and PC reached similar overall results for diagnostic accuracy (AN: 88.9 vs PC: 96.1, P = 0.25), specimen adequacy (AN: 96.4% vs PC: 91.1%, P = 0.38), mean number of passes (AN: 1.5 vs PC: 1.7, P = 0.14), mean cellularity score (AN: 1.7 vs PC: 1.1, P = 0.058), and complications (none). A diagnosis on the basis of histology was achieved in the PC group in 36 (64.3%) patients, and in 2 of those as the sole modality. In patients with available histology the mean cellularity score was higher for AN (AN: 1.7 vs PC: 1.0, P = 0.034); no other differences were of statistical significance.Both needles achieved high overall diagnostic yields and similar performance characteristics for cytological diagnosis; histological analysis was only possible in 2/3 of cases with the new needle.
| S-EPMC5075557 | biostudies-literature
Project description:BACKGROUND:Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. Authors believe a smaller gauge needle may lead to less intravascular uptake and less pain. Theoretically, there is less chance for a smaller gauge needle to encounter a blood vessel during an injection compared to a larger gauge needle. Studies have also shown smaller gauge needle to cause less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception. METHODS:This was a prospective single blind randomized clinical trial performed at outpatient spine practice locations of two academic institutions. One hundred sixty-two consecutive patients undergoing lumbosacral transforaminal epidural injections from February 2018 to June 2019 were recruited and randomized to each arm of the study - 84 patients were randomized to the 22-gauge needle arm and 78 patients to 25-gauge arm. Each transforaminal injection level was considered a separate incidence, hence total number of incidence was 249 (136 in 22-gauge arm and 113 in 25-gauge arm). The primary outcome measure was intravascular uptake during live fluoroscopy and/or blood aspiration. The secondary outcome measure was patient reported pain during the procedure on the numerical rating scale. RESULTS:Fisher exact test was used to detect differences between 2 groups in regards to intravascular uptake and paired t-tests were used to detect differences in pain scores. The incidence of intravascular uptake for a 22-gauge needle was 5.9% (95% confidence interval: 1.9 to 9.8%) and for a 25-gauge needle, 7.1% (95% confidence interval: 2.4 to 11.8%) [p?=?0.701]. Average numerical rating scale scores during the initial needle entry for 22-gauge and 25-gauge needle was 3.46 (95% confidence interval: 2.94 to 3.98) and 3.13 (95% confidence interval: 2.57 to 3.69) respectively [p?=?0.375]. CONCLUSIONS:The study showed no statistically significant difference in intravascular uptake or pain perception between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injections. TRIAL REGISTRATION:ClinicalTrials.gov NCT04350307. Registered 4/17/2020. (Retrospectively registered).
| S-EPMC7469311 | biostudies-literature
Project description:The purpose of the study was to report our initial experience with the transconjunctival Intrascleral Intraocular Lens (SFIOL) fixation with modified Yamane's double-needle technique and flanged haptics.This was a prospective interventional study that enrolled 31 consecutive patients undergoing SFIOL with the modified Yamane's technique. All patients underwent comprehensive evaluation including uncorrected and best-corrected vision, intraocular pressure, ultrasound biomicroscopy, endothelial cell density, and macular thickness using optical coherence tomography (OCT). We excluded patients with visually significant coexistent pathology such as corneal scars, macular pathology, and glaucoma.The mean age of subjects was 57 ± 16.9 years and 23 were men (74%). Surgery was performed for aphakia following complicated cataract surgery in 10 eyes (32%), with lensectomy for subluxated/dislocated cataract in 6 eyes (19%), and with IOL explantation for subluxated/dislocated IOL in 15 eyes (48%). There were no intraoperative complications. Uncorrected visual acuity improved from median of 1.48 logarithm of minimum angle of resolution (logMAR) units (interquartile range [IQR] = 1.3-2 logMAR) at baseline to 0.3 logMAR (IQR = 0.2-0.4 logMAR) at 6 weeks (P < 0.001) which was maintained at 6 months. There were no significant changes in endothelial cell density (P = 0.34) and OCT-based macular thickness (P = 0.31) at 6 months. Two eyes had slight IOL decentration.Our initial experience suggests that the Yamane's technique for SFIOL is a simple procedure with a short-learning curve and is independent of scleral flaps, tunnels, sutures, and fibrin glue. Using widely available 27-gauge needle instead of 30-gauge thin wall needle as originally described by Yamane makes it possible for the use of various three-piece IOLs available globally. Further studies are required for widespread acceptance of this technique.
| S-EPMC5742981 | biostudies-literature
Project description:ObjectiveTo investigate the effects of needle infusion on preventing wound leakage and hypotony in sutureless vitrectomy.MethodsWe retrospectively reviewed 230 consecutive eyes of 23-gauge pars plana vitrectomy with or without needle infusion, and further measured the wound leakage and intraocular pressure (IOP) without using a suture.ResultsIn the eyes with primary needle infusion inserted before infusion cannula removal, IOP was stable during and after infusion cannula removal. No suture was needed in the procedure. Postoperative hypotony did not occurred in all eyes with needle infusion either.ConclusionNeedle infusion inserted before infusion cannula removal can avoid using sutures and prevent hypotony intraoperatively and postoperatively.
| S-EPMC4694452 | biostudies-literature
Project description:BACKGROUND AND OBJECTIVES:Previous limited experiences have reported the 19-gauge flexible needle to be highly effective in performing endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for transduodenal lesions. We designed a large multicenter prospective study with the aim at evaluating the performance of this newly developed needle. PATIENTS AND METHODS:Consecutive patients with solid lesions who needed to undergo EUS sampling from the duodenum were enrolled in 6 tertiary care referral centers. Puncture of the lesion was performed with the 19-gauge flexible needle (Expect™ and Slimline Expect™ 19 Flex). The feasibility, procurement yield, and diagnostic accuracy were evaluated. RESULTS:Totally, 246 patients (144 males, mean age 65.1 ± 12.7 years) with solid lesions (203 cases) or enlarged lymph nodes (43 cases) were enrolled, with a mean size of 32.6 ± 12.2 mm. The procedure was technically feasible in 228 patients, with an overall procurement yield of 76.8%. Two centers had suboptimal procurement yields (66.7% and 64.2%). Major complications occurred in six cases: two of bleeding, two of mild acute pancreatitis, one perforation requiring surgery, and one duodenal hematoma. Considering malignant versus nonmalignant disease, the sensitivity, specificity, positive/negative likelihood ratios, and diagnostic accuracy were 70.7% (95% confidence interval [CI]: 64.3-76.6), 100% (95% CI: 79.6-100), 35.3 (95% CI: 2.3-549.8)/0.3 (95% CI: 0.2-0.4), and 73.6% (95% CI: 67.6-79). On multivariate analysis, the only determinant of successful EUS-FNB was the center in which the procedure was performed. CONCLUSIONS:Our results suggest that the use of the 19-gauge flexible needle cannot be widely advocated and its implementation should receive local validation after careful evaluation of both the technical success rates and diagnostic yield.
| S-EPMC5752763 | biostudies-literature
Project description:Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure originally performed using a 22-gauge (22G) needle. A recently introduced 21-gauge (21G) needle may improve the diagnostic yield and sample adequacy of EBUS-TBNA, but prior smaller studies have shown conflicting results. To our knowledge, this is the largest study undertaken to date to determine whether the 21G needle adds diagnostic benefit.We retrospectively evaluated the results of 1,299 patients from the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation (AQuIRE) Diagnostic Registry who underwent EBUS-TBNA between February 2009 and September 2010 at six centers throughout the United States. Data collection included patient demographics, sample adequacy, and diagnostic yield. Analysis consisted of univariate and multivariate hierarchical logistic regression comparing diagnostic yield and sample adequacy of EBUS-TBNA specimens by needle gauge.A total of 1,235 patients met inclusion criteria. Sample adequacy was obtained in 94.9% of the 22G needle group and in 94.6% of the 21G needle group (P = .81). A diagnosis was made in 51.4% of the 22G and 51.3% of the 21G groups (P = .98). Multivariate hierarchical logistic regression showed no statistical difference in sample adequacy or diagnostic yield between the two groups. The presence of rapid onsite cytologic evaluation was associated with significantly fewer needle passes per procedure when using the 21G needle (P < .001).There is no difference in specimen adequacy or diagnostic yield between the 21G and 22G needle groups. EBUS-TBNA in conjunction with rapid onsite cytologic evaluation and a 21G needle is associated with fewer needle passes compared with a 22G needle.
| S-EPMC4694078 | biostudies-other
Project description:BACKGROUND Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has been used for detecting pancreatic cancer. We aimed to compare the diagnostic yield of both 22-gauge and 25-gauge EUS-FNA for the detection of pancreatic cancer. MATERIAL AND METHODS We searched the electronic databases including PubMed, EMBASE, Web of Science, Scopus, and Cochrane Library up to June 13, 2017. Two reviewers independently screened studies and extracted data. RESULTS We analyzed data from 1824 patients from 16 included studies. The estimated pooled data for the 22-gauge needles reported sensitivity was 0.89 (0.83-0.93), specificity was 1.00 (0.74-1.00), positive LR was 485.28 (2.55-92 000) and negative LR was 0.11 (0.07-0.17). Results for the 25-gauge needles showed the pooled sensitivity, specificity, positive and negative LR was 0.90 (0.86-0.93), 0.99 (0.89-1.00), 59.53 (7.99-443.66), and 0.10 (0.07-0.14), respectively. The 25-gauge needle had significantly higher pooled sensitivity than the 22-gauge needle (0.90 vs. 0.87, ?²=5.26, P=0.02) while there was no difference in the pooled specificity (0.96 vs. 0.98, ?²=2.12, P=0.15). The quality of most studies was assessed favorable using QUADAS-2 (quality assessment of diagnostic accuracy studies-2). CONCLUSIONS Our findings revealed that the 25-gauge EUS-FNA used for pancreatic lesions could have a higher diagnostic yield than using 22-gauge EUS-FNA. Nevertheless, well-designed prospective studies recruiting more patients are needed.
| S-EPMC6257123 | biostudies-literature
Project description:Background and study aims ?EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs. Patients and methods ?All adult patients referred for EUS evaluation of upper gastrointestinal SETs ??15?mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group.?Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment. Results ?A total of 56 patients (31 male (55.37?%); mean age, 67.41?±?12.70 years) were randomized to either EUS-FNB (n?=?26) or SINK (n?=?30). Technical success was 96.15?% and 96.66?%, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78?%). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76?% vs. 89.28?%, respectively; P ?=?0.278). The rate of adverse events (none severe) was also comparable (7.69?% vs. 10?%, respectively; P?=? 1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group. Conclusion ?EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding.
| S-EPMC7035036 | biostudies-literature
Project description:BACKGROUND:Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) may facilitate tissue acquisition for a definitive diagnosis of gastrointestinal subepithelial tumors (SETs). This study aimed to determine the diagnostic yield of EUS-FNB using a novel 20-gauge ProCore needle with a coiled sheath in tissue sampling of gastrointestinal SETs. METHODS:Between July 2016 and February 2017, 39 patients with gastrointestinal SETs were prospectively recruited from six university hospitals in Korea. Hypoechoic SETs ?2 cm in size and originating from the submucosal and/or muscularis propria layer under EUS were eligible. This study was registered on ClinicalTrials.gov (NCT02884154). RESULTS:A total of 36 patients were included in the final analyses. EUS-FNB was diagnostic in 88.9% of SETs. Tissue adequacy was judged as optimal in 97.2% of FNB specimens according to on-site visual evaluation by endosonographers, and in 88.9% of specimens according to pathologists. A macroscopically optimal core sample was obtained with two needle passes in 94.4% of cases. Technical failure rate was encountered in two cases (5.6%) after two needle passes. There were two cases (5.6%) of bleeding, which was managed endoscopically. CONCLUSIONS:EUS-FNB using a 20-gauge ProCore needle is a technically feasible and effective modality for histopathologic diagnosis of gastrointestinal SETs, providing adequate core samples with fewer needle passes; ClinicalTrials.gov number, NCT02884154.
| S-EPMC6194594 | biostudies-literature