Diagnostic yield of EUS-guided through-the-needle microforceps biopsy versus EUS-FNA of pancreatic cystic lesions: a systematic review and meta-analysis.
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ABSTRACT: Background and study aims Accurate diagnosis and risk stratification of pancreatic cysts (PCs) is challenging. The aim of this study was to perform a systematic review and meta-analysis to assess the feasibility, safety, and diagnostic yield of endoscopic ultrasound-guided through-the-needle biopsy (TTNB) versus fine-needle aspiration (FNA) in PCs. Methods Comprehensive search of databases (PubMed, EMBASE, Cochrane, Web of Science) for relevant studies on TTNB of PCs (from inception to June 2019). The primary outcome was to compare the pooled diagnostic yield and concordance rate with surgical pathology of TTNB histology and FNA cytology of PCs. The secondary outcome was to estimate the safety profile of TTNB. Results: Eight studies (426 patients) were included. The diagnostic yield was significantly higher with TTNB over FNA for a specific cyst type (OR: 9.4; 95 % CI: [5.7-15.4]; I 2 = 48) or a mucinous cyst (MC) (OR: 3.9; 95 % CI: [2.0-7.4], I 2 = 72 %). The concordance rate with surgical pathology was significantly higher with TTNB over FNA for a specific cyst type (OR: 13.5; 95 % CI: [3.5-52.3]; I 2 = 48), for a MC (OR: 8.9; 95 % [CI: 1.9-40.8]; I 2 = 29), and for MC histologic severity (OR: 10.4; 95 % CI: [2.9-36.9]; I 2 = 0). The pooled sensitivity and specificity of TTNB for MCs were 90.1 % (95 % CI: [78.4-97.6]; I 2 = 36.5 %) and 94 % (95 % CI: [81.5-99.7]; I 2 = 0), respectively. The pooled adverse event rate was 7.0 % (95 % CI: [2.3-14.1]; I 2 = 82.9). Conclusions TTNB is safe, has a high sensitivity and specificity for MCs and may be superior to FNA cytology in risk-stratifying MCs and providing a specific cyst diagnosis.
Project description:Background and aimsDifferentiating pancreatic cystic lesions remains a challenge when the current technique of EUS-guided FNA is used. Recently, a miniaturized biopsy forceps with an outer diameter of 0.8 mm has been developed, thus allowing it to be passed through the bore of a standard 19-gauge FNA needle to acquire tissue.MethodsThis study consisted of a retrospective review of all cases of EUS-guided through-the-needle forceps biopsy technique (TTNFB) performed for pancreatic cystic lesions at a single academic tertiary care center over a 12-month period. Technical success was defined as acquisition of adequate tissue for formal histologic analysis. Safety was assessed through the monitoring and recording of periprocedural and postprocedural adverse events.ResultsThe technical success of EUS-guided TTNFB was 87% (13/15). EUS-guided TTNFB with histologic analysis yielded pancreatic cyst diagnoses in 11 of 15 (73%) patients, compared with 0 of 15 (0%) patients with the use of EUS-FNA and cytologic analysis (P < .001). Of the 15 cystic lesions, 8 were diagnosed as intrapapillary mucinous neoplasm based on EUS-TTNFB.ConclusionThis TTNFB technique has the potential to improve the diagnostic yield of EUS-FNA for pancreatic cystic neoplasms.
Project description:Background and study aimDue to the scarcity of specific data on endoscopic ultrasound (EUS)-guided fine-needle biopsies (SharkCore) FNB in the evaluation of pancreatic lesions, we performed a prospective study of the diagnostic performance of EUS SharkCore FNB in patients with pancreatic lesions. The aim of this study was to evaluate the diagnostic accuracy.Patients and methodsSingle-center prospective study of 41 consecutive patients referred for EUS-FNB from October 2015 to April 2016 at our center. EUS-FNB was obtained in a predefined setting regarding the procedure and pathological evaluation. Data regarding demographics, lesion, technical parameters, and diagnostic accuracy were obtained.ResultsThe study included 41 consecutive patients (22 males (54 %); median age 68 years). The average size of the lesions was 28 mm (median: 30 mm). A diagnostic specimen was identified in 40 (98 %) cases during microscopy with an average of 2.4 passes. The route was trans-duodenal in 20 cases (49 %). The histological diagnosis of the specimens was malignant in 29 cases (71 %), benign in 8 (20 %), suspicious in 2 (5 %), atypical in 1 (2 %) and in 1 (2 %) no material for microscopic evaluation was obtained. This led to a diagnostic accuracy of 93 %, sensitivity of 91 % and a specificity of 100 %. 2 cases (5 %) of self-limiting bleeding were observed. The diagnosis at follow up was malignant in 32 (78 %) of the patients.ConclusionsEUS-FNB of pancreatic mass lesions with the SharkCore needle produced specimens with a diagnostic accuracy of 93 %. The procedure was safe and easy to perform, and these data support the use of EUS-FNB in a routine setting.
Project description:Background and objectivesSeveral types of needles are available for EUS-guided tissue sampling of pancreatic lesions. Whereas fine-needle aspiration (FNA) needles typically provide cytological samples, fine-needle biopsy (FNB) needles are designed to obtain microcores with preserved tissue architecture. The aim of this study was to compare tissue amount and diagnostic yield between a modified Franseen-type FNB needle (TopGain; Medi-Globe GmbH, Grassau, Germany) and a standard FNA needle.MethodsWe performed a prospective, multicenter randomized controlled study between June 2020 and September 2021, including patients with a solid pancreatic lesion referred for EUS-guided tissue sampling at 3 centers in Denmark. The patients were randomized 1:1 to either FNA needle or the novel FNB needle. Primary outcomes included the number of obtained tissue microcores and total and diagnostic tissue area.ResultsSixty-four patients were included. The median number of tissue microcores procured per pass was significantly higher in the FNB group compared with FNA (3 vs. 2, P < 0.001). Similarly, the mean total tissue area (2.74 vs. 0.44 mm2, P < 0.001) and mean diagnostic tissue area (1.74 vs. 0.28 mm2, P < 0.001) were more than 6-fold larger in the FNB samples compared with FNA. The median number of passes needed for a diagnostic sample was 1 for the FNB needle and 2 for FNA needle (P = 0.12). The novel FNB needle provided a higher percentage of samples of excellent quality (P = 0.002).ConclusionsThe novel Franseen-type FNB needle seems to be significantly superior to a conventional FNA needle. The results of this study underline excellent performance of crown-cut needles.
Project description:Background and study aims Given variable diagnostic yield of endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) for pancreatic cystic lesions (PCLs), a through-the-needle (TTN) microforceps biopsy device passed through a 19-gauge FNA needle has been devised to improve tissue sampling. This was a systematic review and meta-analysis to evaluate the feasibility, diagnostic yield, and safety of EUS-guided TTN microforceps biopsy for diagnosis of PCLs. Methods Individualized searches were developed in accordance with PRISMA and MOOSE guidelines. This was a cumulative meta-analysis performed by calculating pooled proportions with rates estimated using random effects models. Measured outcomes included pooled technical success, diagnostic yield, accuracy, and procedure-associated adverse events (AEs) as well as comparison to conventional FNA. Results Eleven studies (n = 518 patients; mean age 64.13 ± 5.83 years; 58.19 % female) were included. Mean PCL size was 33.39 ± 3.72 mm with the pancreatic head/uncinate (35.50 %) being the most common location. A mean of 2.47 ± 0.92 forceps passes were performed with a mean of 2.79 ± 0.81 microbiopsies obtained per lesion. Pooled technical success was 97.12 % (95 % CI, 93.73-98.71; I 2 = 34.49) with a diagnostic yield of 79.60 % (95 % CI, 72.62-85.16; I 2 = 56.00), and accuracy of 82.76 % [(95 % CI, 77.80-86.80; I 2 = 0.00). The pooled serious adverse event rate was 1.08 % (95 % CI, 0.43-2.69; I 2 = 0.00). Compared to conventional FNA, TTN microforceps biopsy resulted in significant improvement in diagnostic yield [OR 4.79 (95 % CI: 1.52-15.06; P = 0.007)] and diagnostic accuracy [OR 8.69 (95 % CI, 1.12-67.12; P = 0.038)], respectively. Conclusions EUS-guided TTN microforceps biopsy appears to be safe and effective for diagnosis of PCLs with improvement in diagnostic yield and accuracy when compared to FNA alone.
Project description:Background and aimsAlthough conventional EUS-guided FNA (EUS-FNA) has previously been considered first-line for sampling subepithelial lesions (SELs), variable accuracy has resulted in increased use of fine-needle biopsy (FNB) sampling to improve diagnostic yield. The primary aim of this study was to compare FNA versus FNB sampling for the diagnosis of SELs.MethodsThis was a multicenter, retrospective study to evaluate the outcomes of EUS-FNA and EUS-guided FNB sampling (EUS-FNB) of SELs over a 3-year period. Demographics, lesion characteristics, sensitivity, specificity, accuracy, number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell block accuracy, and adverse events were analyzed. Subgroup analyses were performed comparing FNA versus FNB sampling by location and diagnostic yield with or without ROSE. Multivariable logistic regression was also performed.ResultsTwo hundred twenty-nine patients with SELs (115 FNA and 114 FNB sampling) underwent EUS-guided sampling. Mean patient age was 60.86 ± 12.84 years. Most lesions were gastric in location (75.55%) and from the fourth layer (71.18%). Cell block for FNB sampling required fewer passes to achieve conclusive diagnosis (2.94 ± 1.09 vs 3.55 ± 1.55; P = .003). The number of passes was not different for ROSE adequacy (P = .167). Immunohistochemistry was more able to be successfully performed in more FNB sampling samples (69.30% vs 40.00%; P < .001). Overall, sensitivity and accuracy were superior for FNB sampling versus FNA (79.41% vs 51.92% [P = .001] and 88.03% vs 77.19% [P = .030], respectively). On subgroup analysis, sensitivity and accuracy of FNB sampling alone was superior to FNA + ROSE (79.03% vs 46.67% [P = .001] and 87.25% vs 68.00% [P = .024], respectively). There was no significant difference in diagnostic yield of FNB sampling alone versus FNB sampling + ROSE (P > .05). Multivariate analysis showed no predictors associated with accuracy. One minor adverse event was reported in the FNA group.ConclusionsEUS-FNB was superior to EUS-FNA in the diagnosis of SELs. EUS-FNB was also superior to EUS-FNA alone and EUS-FNA + ROSE. These results suggest EUS-FNB should be considered a first-line modality and may suggest a reduced role for ROSE in the diagnosis of SELs. However, a large randomized controlled trial is required to confirm our findings.
Project description:BackgroundLinear endoscopic ultrasonography (EUS) allows the visualization, identification, and characterization of the extent of lesions of the gastrointestinal (GI) tract and adjacent structures. EUS-guided fine-needle aspiration (EUS-FNA) facilitates a more accurate diagnosis of mediastinal, intra-abdominal, and pancreatic lesions through the collection of the cytological material under direct visualization. Recent reports suggest that histological samples can be obtained by EUS-FNA with a reverse, bevel-tipped needle (the ProCore needle) to collect the core samples (fine needle biopsy, FNB), thereby adding a new dimension to the diagnostic usefulness of this technique. Certain neoplasms, such as lymphoma and stromal tumors, can be assessed by EUS-FNB to confirm the diagnosis. Here, we aimed to carry out a prospective, multicenter, single-blind, randomized, controlled trial to compare EUS-FNB and EUS-FNA.Methods/designA total of 408 patients will be enrolled from five endoscopic centers. Patients will be divided into two groups: (1) group A, which is the EUS regular needle group (EUS-FNA) and (2) group B, which is the EUS ProCore needle group (EUS-FNB). Patients in group A will be examined with a 22G EchoTip Ultra needle, and patients in group B, with a 22G EchoTip ProCore needle. For all included patients, four EUS-guided passes will be made in each lesion. In the first and second pass, a slow-pull suction method of the stylet will be done. The third and fourth pass will use manual suction of 5 cc. The primary objective is to compare the diagnostic yield of malignancy by EUS-FNA versus EUS-FNB.DiscussionThe trial will compare samples obtained by EUS-FNA versus EUS-FNB for the diagnostic yield of solid lesions. The efficacy of these two sampling methods will be assessed on various lesions, which may provide insights into developing practice guidelines for their future indications.Trial registrationClinical Trials.gov, NCT02327065 .
Project description:Pancreatic cancer has one of the worst prognoses among all malignancies and few available treatment options. Patient-derived xenografts can be used to develop personalized therapy for pancreatic cancer. Endoscopic ultrasound fine-needle aspiration (EUS-FNA) may provide a powerful alternative to surgery for obtaining sufficient tissue for the establishment of patient-derived xenografts. In this study, EUS-FNA samples were obtained for 30 patients referred to the Ottawa Hospital, Ottawa, Ontario, Canada. These samples were used for xenotransplantation in NOD-SCID mice and for genetic analyses. The gene expression of pancreatic-cancer-relevant genes in xenograft tumors was examined by immunohistochemistry. Targeted sequencing of both the patient-derived tumors and xenograft tumors was performed. The xenografts' susceptibility to oncolytic virus infection was studied by infecting xenograft-derived cells with VSV∆51-GFP. The xenograft take rate was found to be 75.9% for passage 1 and 100% for passage 2. Eighty percent of patient tumor samples were successfully sequenced to a high depth for 42 cancer genes. Xenograft histological characteristics and marker expression were maintained between passages. All tested xenograft samples were susceptible to oncoviral infection. We found that EUS-FNA is an accessible, minimally invasive technique that can be used to acquire adequate pancreatic cancer tissue for the generation of patient-derived xenografts and for genetic sequencing.