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Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study

Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study - Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041530
Enrollment
20
Registered
2020-08-25
Start date
2020-08-21
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

extrahepatic cholangiocarcinoma

Interventions

Cholangioscopy-guided mapping biopsy

Sponsors

Sendai City Medical Center, Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Suspected extrahepatic cholangiocarcinoma based on the findings from MDCT. Being resectable from MDCT findings. Written informed consent about participating in the study.

Exclusion criteria

Exclusion criteria: Impossible transpapillary approach using a duodenoscope. Poor general condition (the Eastern Cooperative Oncology Group performance status 3 or 4). Definite inoperable factors, such as distal metastases and peritoneal dissemination detected. Refusal of surgical treatment. Pregnancy.

Design outcomes

Primary

MeasureTime frame
The rate of site-based successful biopsy—

Secondary

MeasureTime frame
Success rate of approaching the target sites The rate of specimen-based successful biopsy Diagnostic accuracy of lateral spread based on the cholangioscopic finding and cholangioscopy-guided mapping biopsy Adverse events—

Countries

Japan

Contacts

Public ContactTakahisa Ogawa

Sendai City Medical Center Department of Gastroenterology

t-ogawa@openhp.or.jp81-22-252-1111

Outcome results

None listed

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