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Randomized Trial Comparing Franseen Needle Versus Trident Needle and Three-Point Needle in EUS-FNB for Solid Pancreatic Lesions (Fantathtic Study)

Randomized trial in EUS-FNB for solid pancreatic lesions (Fantathtic Study)

192

From February to October 2023, 192 patients were enrolled, and 185 of them were included in the final analysis (63 in Conventional needle group and 122 in Novel needle group) . The mean age was 71.5 years (SD 10.6), and 85 (44%) patients were male. The average mass size was 29.2 mm (SD 14.7).

The enrollment pace exceeded the initial expectations. Regarding the number of patients registered at each institution, Nagoya University Hospital contributed 66 patients, accounting for approximately one-third of the total, while all other participating institutions registered at least five patients each. Of the 192 patients enrolled, 65 were randomized to the conventional needle group and 127 to the novel needle group. Subsequently, two patients were excluded from the conventional needle group (one diagnosed with a cystic lesion by EUS and one who withdrew consent), and five patients were excluded from the novel needle group (one in whom the scope could not pass the duodenum due to stenosis and was switched to puncture of a liver metastasis, two in whom the procedure could not be performed due to poor sedation, and two who withdrew consent). Ultimately, 185 patients (63 in the conventional needle group and 122 in the novel needle group) were included in the final analysis.

Adverse events were observed in two patients (1.6%) in the novel needle group (Group N). One patient developed hyperamylasemia, and the other experienced mild postprocedural abdominal pain; both resolved with conservative treatment. No adverse events were observed in the conventional needle group (Group C). Equipment-related issues occurred in six cases (3.2%), consisting of three cases of needle bending, two cases of needle-lock system malfunction, and one case in which the needle could not be advanced out of the scope. Needle-lock malfunctions occurred once in each group, while needle bending was observed in one case in the conventional needle group and two cases in the novel needle group. The case in which the needle could not be advanced was also due to needle bending, and all three of these cases involved the 3-point needle.

The tissue-collection rates were 96.8% for the conventional needle and 92.6% for the novel FNB needles. The novel needles presented slightly lower tissue-collection rates, although this difference was not statistically significant. Furthermore, this difference was -4.2% (90% confidence interval: -9.53-1.12), which did not indicate noninferiority. However, the novel needles significantly outperformed the conventional needles in terms of initial puncture success and overall puncture performance. No significant differences were found in histological diagnosis, tissue volume, or adverse events between the groups.

Both the novel FNB needles and the conventional Franseen needle demonstrated high tissue-collection rates, with no significant differences in diagnostic performance or specimen volume. While noninferiority of the novel FNB needles was not established, they significantly improved puncture success and performance. This improvement could be particularly advantageous for nonexpert endoscopists and in complex cases.

Nov. 01, 2025

May. 20, 2025

https://pubmed.ncbi.nlm.nih.gov/40120866/

No

NA

https://jrct.mhlw.go.jp/latest-detail/jRCT1042220099

Ishikawa Takuya

Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya

ishitaku@med.nagoya-u.ac.jp

Ishikawa Takuya

Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya

+81-52-744-2602

ishitaku@med.nagoya-u.ac.jp

Complete

Nov. 25, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

diagnostic purpose

(1) Patients with solid pancreatic lesions not less than 10 mm on CT or MRI which require histological diagnosis by EUS-FNB.
(2) Patients over 20 years old at the time of enrollment.
(3) Preservation of bone marrow function at the time of diagnosis.
(4) Patients in which antithrombotic drugs are not used within one week or can be withdrawn or replaced.
(5) Provision of written consent to participate in the study.

(1) Uncontrollable infection including active tuberculosis
(2) Serious adverse events
(3) Severe mental disorder
(4) Judgement as being ineligible by the principal or subinvestigator.

Both

Solid pancreatic lesions not less than 10 mm

Subjects will be randomly assigned to a conventional needle group or a new needle group for the needle used during EUS-FNB.
Conventional needle group: 22G Franseen needle (Acquire TM) will be used. New needle group: 22G Trident needle (Trident TM) or 3-Point needle (TopGain TM) will be used. Since it is expected that some facilities will have difficulty employing both needles, one of the needles will be used in the new needle group, and in facilities where both needles can be used, they will be used alternatively.

Pancreas

Histological tissue collection rate

Histological tissue collection rate among new needles
Histological diagnostic ability
Puncture success rate at first shot
Evaluation of the easiness of the puncture
Adverse events
Comparison of core tissue length and area

+81-52-744-2479

Nov. 11, 2022

none