Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial

doi:10.1016/j.cgh.2017.07.010

Clinical Gastroenterology and Hepatology

Volume 16, Issue 8, August 2018, Pages 1314-1321

https://doi.org/10.1016/j.cgh.2017.07.010 Get rights and content

Background & Aims

Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. We conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with pancreatic and nonpancreatic masses.

Methods

We performed a prospective single-blind study at 5 tertiary care centers in China. The study comprised 408 patients undergoing EUS for a solid mass (>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity, from December 2014 through January 2016. Patients were randomly assigned to groups (1:1) for assessment by FNA (n = 190) or FNB (n = 187). After lesions were identified by EUS, samples were collected in a total of 4 passes by each needle. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as pancreatic and nonpancreatic masses. The secondary endpoint was the quality of histologic specimen.

Results

Findings from FNB analysis were accurate for 91.44% of all cases, compared with 80.00% for all FNA cases, based on final patient diagnoses (P = .0015). In patients with pancreatic masses (n = 249), findings from histologic analysis of FNBs were accurate for 92.68% of the cases, compared with 81.75% for FNAs (P = .0099). In cytology analysis of pancreatic masses, samples collected by FNB accurately identified 88.62% of all pancreatic lesions, whereas samples collected by FNA accurately identified 79.37% (P = .00468). Analyses of samples of nonpancreatic masses collected by FNA versus FNB produced similar diagnostic yields.

Conclusions

In a prospective study of patients with pancreatic masses, we found EUS-guided FNB samples to produce more accurate diagnoses than samples collected by EUS-guided FNA samples. No difference in diagnostic yield was seen between EUS-FNA and EUS-FNB for nonpancreatic masses. Clinical Trials.gov no: NCT02327065.

Section snippets

Study Design

This multicenter prospective single-blind and randomized controlled trial was conducted at 5 tertiary-care medical centers in China: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan; Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing; Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai; Sun Yat-sen University Cancer Center, Guangzhou; and the First

Patient Characteristics

In total, 190 patients in the FNA group and 187 in the FNB group were prospectively analyzed (Figure 1). The mean age in the FNA group was 58.3 years versus 58.3 years in the FNB group. Most of the patients were men in both groups (Table 1).

The final diagnoses were based on evaluating EUS specimen, surgical pathology, and clinical courses within 48 weeks follow-up time (Table 1). For those who died during follow-up because of disease deterioration, the follow-up time was the number of weeks

Discussion

ProCore FNB needle with a side hole is designed to obtain a core specimen and hence aims to improve histologic analysis1, 15 and ultimately the diagnostic yield. However, previous prospective, randomized controlled trials comparing the ProCore FNB and standard FNA needles failed to show significant benefits of ProCore FNB in evaluating pancreatic lesions. Notably, a study of 116 cases suggested that overall accuracy of the 2 techniques in patients with solid pancreatic masses was comparable,

Acknowledgments

The authors thank the staff at the Endoscopy Unit of Tongji Hospital for their contributions. They also thank all study statisticians from the Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China who contributed to data analysis. They are grateful for Dr Shou Jiang Tang (University of Mississippi Medical Center) for providing a critical review of the manuscript and the editorial assistance with

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: Conflicts of interest The authors disclose no conflicts.

: Funding This work was supported in part by grants of the National Natural Science Foundation of China (81372352, 81471612) and Innovation Research–Translational Medicine Grants of Huazhong University of Science and Technology (No. 01-18-540028).

^a: These authors contributed equally to this manuscript.

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Original articlePancreas, biliary tract, and liverAnalysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial

Background & Aims

Methods

Results

Conclusions

Section snippets

Study Design

Patient Characteristics

Discussion

Acknowledgments

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Comparison of 22-gauge aspiration needle with 22-gauge biopsy needle in endoscopic ultrasonography-guided subepithelial tumor sampling

Scand J Gastroenterol

Original article
Pancreas, biliary tract, and liver
Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial