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Endoscopy 2021; 53(11): 1132-1140
DOI: 10.1055/a-1311-9927
Original article

Fine-needle aspiration of pancreatic cystic lesions: a randomized study with long-term follow-up comparing standard and flexible needles

Mohammad Al-Haddad  ‡   *
1   Division of Gastroenterology and Hepatology, Indiana University, Indianapolis, Indiana, USA
,
Michael B. Wallace  ‡   *
2   Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
,
William Brugge
3   Division of Gastroenterology, Massachusetts General Hospital, Boston Massachusetts, USA
,
Sundeep Lakhtakia
4   Asian Institute of Gastroenterology, Hyderabad, India
,
Zhao-Shen Li
5   Changhai Hospital, Shanghai, China
,
Amrita Sethi
6   Division of Digestive and Liver Diseases, Columbia Presbyterian, New York, New York, USA
,
Douglas Pleskow 
7   Division of Gastroenterology, Beth Israel Deaconess Hospital, Boston, Massachusetts, USA
,
Cuong C. Nguyen
8   Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
,
Rahul Pannala
8   Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
,
John DeWitt
1   Division of Gastroenterology and Hepatology, Indiana University, Indianapolis, Indiana, USA
,
Massimo Raimondo
2   Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
,
Timothy A. Woodward
2   Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
,
Mohan J. Ramchandani 
4   Asian Institute of Gastroenterology, Hyderabad, India
,
Zhendong Jin
5   Changhai Hospital, Shanghai, China
,
Can Xu
5   Changhai Hospital, Shanghai, China
,
Douglas O. Faigel
8   Division of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
› Author AffiliationsTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT01711294 Type of study: Randomized controlled trial
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Comments on: “Fine-needle aspiration of pancreatic cystic lesions: a randomized study with long-term follow-up comparing standard and flexible needles”Endoscopy 2021; 53(09): 987-987
DOI: 10.1055/a-1425-5322

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Author commentary on Mohammad Al-Haddad et al.Endoscopy 2021; 53(11): v54-v54
DOI: 10.1055/a-1352-1503

Abstract

Background Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, with the majority having a low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of three FNA needles on diagnostic accuracy, clinical management, and the ability to accrue fluid for tumor markers.

Methods A multicenter prospective trial randomized 250 patients with PCLs ≥ 13 mm 2:1:1 to 19G Flex, 19G, and 22G needles with crossover for repeated FNA procedures. Diagnostic accuracy was established at 2-year follow-up, with the final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review.

Results Enrolled patients (36 % symptomatic) had PCLs in the head (44 %), body (28 %), and tail (26 %). Percentage of cyst volume aspirated was 78 % (72 % – 84 %) for 19G Flex, 74 % (64 % – 84 %) for 22G, and 73 % (63 % – 83 %) for 19G (P = 0.84). Successful FNA was significantly higher for 19G Flex (89 % [82 % – 94 %]) and 22G (82 % [70 % – 90 %]) compared with 19G (75 % [63 % – 85 %]) (P = 0.02). Repeated FNA was required more frequently in head/uncinate lesions than in body and tail (P < 0.01). Diagnostic accuracy of the cyst aspirate was 84 % (73 % – 91 %) against histopathology at 2-year follow-up (n = 79), and 77 % (70 % – 83 %) against consensus diagnosis among nonsurgical cases (n = 171). Related serious adverse events occurred in 1.2 % (0.2 % – 3.5 %) of patients.

Conclusions Our study results demonstrate a statistically significant difference among the three needles in the overall success rate for aspiration, but not in the percentage of cyst volume aspirated. Flexible needles may be particularly valuable in sampling cystic PCLs in the pancreatic head/uncinate process.

* Equal first authors


Fig.1s, Table 1s–4s



Publication History

Received: 31 July 2020

Accepted: 16 November 2020

Accepted Manuscript online:
16 November 2020

Article published online:
04 February 2021

© 2020. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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