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Multicenter retrospective study for clinical findings in early diagnosis of pancreatic cancer Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma; A multicenter comparative study of video analysis

Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma; A multicenter comparative study of video analysis - Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000044789
Enrollment
60
Registered
2021-07-08
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma ten millimeter or less in diameter High-grade Pancreatic intraepithelial neoplasia (PanIN)

Interventions

None listed

Sponsors

Oita San-ai Medical Center
Lead Sponsor
Department of Gastroenterology and Hepatology, Kindai University Department of Gastroenterology, Tenri Hospital Department of Gastroenterology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with lesions which were histopathologically diagnosed from resected specimen of pancreas as high-grade PanIN without invasive cancer. 2. Patietnts with invasive PDAC 10mm or less in diameter (10mm-PDAC); whose diameter was calculated on histopathological specimen. 3. Patients with lesions which were strongly suspected as a high-grade PanIN lesion but with no evidence of high-grade PanIN or PDAC were also enrolled. In particular, the lesions that histopathologically diagnosed from resected specimen with no evidence of high-grade PanIN, or these with negative results on pancreatic juice cytology at least once and no change on various imaging modalities during more than 3 years follow-up period were defined as non-malignant lesions.

Exclusion criteria

Exclusion criteria: Patients with high-grade intraductal papillary mucinous neoplasm (IPMN), intraductal papillary mucinous carcinoma, and 10mm-PDAC which was treated by preoperative chemotherapy were excluded. In all lesions, the cases with technical difficulties with processing movie files were also excluded.

Design outcomes

Primary

MeasureTime frame
Primary outcome is clarifying characteristic EUS-signs in diagnosis of high-grade PanIN, 10mm-PDAC, and non-malignant pancreatic duct irregularity.

Secondary

MeasureTime frame
Secondary outcome is to evaluate diagnostic performance of EUS-signs. In addition, intra- and inter-observer agreement of EUS-signs was also analyzed in blind review sessions.

Countries

Japan

Contacts

Public ContactRyota Sagami

Oita San-ai Medical Center Department of Gastroenterolgoy

sagami1985@yahoo.co.jp097-541-1311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026