A randomized controlled tiral of endoscopic ultrasonography-guided hepaticogastrostomy vs. endoscopic retrograde cholangiogram-guided self-expandable metal stent placement for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion

A multicenter, randomized controlled tiral of endoscopic ultrasonography-guided hepaticogastrostomy vs. endoscopic retrograde cholangiogram-guided self-expandable metal stent placement for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion - EUS-HGS vs ERC-BS for distal MBO in pancreatic cancer with duodenal invasion

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000048708

Enrollment

Registered

2022-09-01

Start date

2022-06-01

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 cancer

Interventions

Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) Endoscopic retrograde cholangiography guided biliary SEMS placement (ERC-BS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathological or radiologically diagnosed unresectable pancreatic cancer 2) Distal malignant biliary obstruction 3) Endoscopically diagnosed duodenal invasion (Radiological diagnosis for duodenal invasion is allowed in cases indwelled gastroduodenal stent. Pathological diagnosis are not always required regardless of the status of duodenal stent) 4) First SEMS placement for distal malignant biliary obstruction or first reintervention for the transpapillary-placed SEMS dysfucntion 5) Adequate oral intake 6) Age >= 18 years 7) Expecting survival time over 3 months 8) Patients who provided a written consent

Exclusion criteria

Exclusion criteria: 1) Hilar biliary obstuction 2) Indwelled PTBD 3) Prior history of left hepatic lobectomy 4) Massive ascites requiring palliative paracentesis 5) Surgically altered anatomy other than Billroth 1 reconstruction 6) Indwelled or planning to gastroduodenal stent placement covering duodenal papilla 7) Impossible endoscopic access to the duodenal papilla due to duodenal obstruction 8) Performance status of 3-4 9) Bleeding tendency (platelet count <= 50,000/mm3, prothrombin time <= 70%) 10) Impossible to discontinue or replace antithrombotic/anticoagulant agents 11) Heart failure (NYHA of III-IV) or respiratory failure (PaO2 <= 60Torr) 12) pregnant or may be pregnant female 13) Patients who are judged to be inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame
Early recurrent biliary obstruction rate	—

Secondary

Measure	Time frame
1) Technical success rate 2) Clinical success rate 3) Recurrent biliary obstruction rate 4) Time to recurrent biliary obstruction 5) Adverse event 6) Overall survival after SEMS placement	—

Countries

Japan

Contacts

Public ContactNaminatsu Takahara

The University of Tokyo Hospital Department of Gastroenterology

naminatsu-takahara@g.ecc.u-tokyo.ac.jp03-3815-5411

Outcome results

None listed

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