Young Sik Woo1, Kwang Hyuck Lee2,3, Dong Hyo Noh4, Joo Kyung Park2, Kyu Taek Lee2, Jong Kyun Lee2, Kee-Taek Jang5. 1. a Department of Internal Medicine , Kangnam Sacred Heart Hospital, Hallym University College of Medicine , Seoul , Republic of Korea. 2. b Department of Medicine , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea. 3. c Department of Health Sciences and Technology , SAIHST, Sungkyunkwan University , Seoul , Republic of Korea. 4. d Department of Internal Medicine , Eulji University Hospital, Eulji University College of Medicine , Daejeon , Republic of Korea. 5. e Department of Pathology , Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Republic of Korea.
Abstract
BACKGROUND/ OBJECTIVES: No comparative study of 22-gauge biopsy needles (PC22) and 25-gauge biopsy needles (PC25) has been conducted. We prospectively compared the diagnostic accuracy of PC22 and PC25 in patients with pancreatic and peripancreatic solid masses. METHODS: We conducted a randomized noninferiority clinical study from January 2013 to May 2014 at Samsung Medical Center. A cytological and histological specimen of each pass was analyzed separately by an experienced pathologist. The primary outcome was to assess the diagnostic accuracy using the PC22 or PC25. Secondary outcomes included the optimal number of passes for adequate diagnosis, core specimen yield, sample adequacy, and complication rates. RESULTS:Diagnostic accuracy of combining cytology with histology in three cumulative passes was 97.1% (100/103) for the PC22 and 91.3% (94/103) for the PC25 group. Thus, noninferiority of PC25 to PC22 was not shown with a 10% noninferiority margin (difference, -5.8%; 95% CI, -12.1 to -0.5%). In a pairwise comparison with each needle type, two passes was non-inferior to three passes in the PC22 (96.1% vs. 97.1%; difference, -0.97%; 95% CI -6.63 to 4.69%) but noninferiority of two passes to three passes was not shown in the PC25 group (87.4% vs. 91.3%; difference, -3.88%; 95% CI, -13.5 to 5.7%). CONCLUSIONS: Non-inferiority of PC25 to PC22 diagnostic accuracy was not observed for solid pancreatic or peripancreatic masses without on-site cytology. PC22 may be a more ideal device because only two PC22 needle passes was sufficient to establish an adequate diagnosis, whereas PC25 required three or more needle passes.
RCT Entities:
BACKGROUND/ OBJECTIVES: No comparative study of 22-gauge biopsy needles (PC22) and 25-gauge biopsy needles (PC25) has been conducted. We prospectively compared the diagnostic accuracy of PC22 and PC25 in patients with pancreatic and peripancreatic solid masses. METHODS: We conducted a randomized noninferiority clinical study from January 2013 to May 2014 at Samsung Medical Center. A cytological and histological specimen of each pass was analyzed separately by an experienced pathologist. The primary outcome was to assess the diagnostic accuracy using the PC22 or PC25. Secondary outcomes included the optimal number of passes for adequate diagnosis, core specimen yield, sample adequacy, and complication rates. RESULTS: Diagnostic accuracy of combining cytology with histology in three cumulative passes was 97.1% (100/103) for the PC22 and 91.3% (94/103) for the PC25 group. Thus, noninferiority of PC25 to PC22 was not shown with a 10% noninferiority margin (difference, -5.8%; 95% CI, -12.1 to -0.5%). In a pairwise comparison with each needle type, two passes was non-inferior to three passes in the PC22 (96.1% vs. 97.1%; difference, -0.97%; 95% CI -6.63 to 4.69%) but noninferiority of two passes to three passes was not shown in the PC25 group (87.4% vs. 91.3%; difference, -3.88%; 95% CI, -13.5 to 5.7%). CONCLUSIONS: Non-inferiority of PC25 to PC22 diagnostic accuracy was not observed for solid pancreatic or peripancreatic masses without on-site cytology. PC22 may be a more ideal device because only two PC22 needle passes was sufficient to establish an adequate diagnosis, whereas PC25 required three or more needle passes.
Authors: Hannah M Schutz; Rutger Quispel; Bart J Veldt; Frank M M Smedts; Marie-Paule G F Anten; Klaas J Hoogduin; Pieter Honkoop; Francien H van Nederveen; Lieke Hol; Mike Kliffen; Claire E Fitzpatrick; Nicole S Erler; Marco J Bruno; Lydi M J W van Driel Journal: Endosc Int Open Date: 2022-04-14
Authors: Samuel Han; Furqan Bhullar; Omar Alaber; Ayesha Kamal; Puanani Hopson; Kavin Kanthasamy; Sarah Coughlin; Livia Archibugi; Nikhil Thiruvengadam; Christopher Moreau; David Jin; Pedram Paragomi; Francisco Valverde-López; Sajan Nagpal; Cemal Yazici; Georgios Papchristou; Peter J Lee; Venkata Akshintala Journal: Endosc Int Open Date: 2021-05-27