Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial

Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation for unresectable malignant distal biliary obstruction: a phase 2 prospective trial - CYCLONE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042767

Enrollment

Registered

2021-01-14

Start date

2021-02-01

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

unresectable malignant distal biliary obstruction

Interventions

EUS-CDS without fistula dilation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Unresectable malignant distal biliary obstruction. 2) Indication for EUS-CDS procedure. 3) One of the following conditions (1), (2), or (3) is met. (1) Total bilirubin >1.5 mg/dL, (2) AST >100 U/L, or (3) ALT >100 U/L. 4) No parenchymal jaundice. 5) No bleeding tendency (platelets >= 50,000, prothrombin (PT) activity time >= 50%). 6) Hemoglobin level >= 8g/dL. 7) Performance status (ECOG): 0, 1, 2. 8) Age: 20 years or older. 9) Patient's written consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1) Judgement unsuitableness by the doctor. 2) Acute cholangitis with moderate or severe in the severity classification.

Design outcomes

Primary

Measure	Time frame
Technical success	—

Countries

Japan

Contacts

Public ContactTakehiko Koga

National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology Division

takehikoga@gmail.com03-3542-2511

Outcome results

None listed

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