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

A randmised controlled tiral of endoscopic sonography-guided hepatic gastrostomy 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-jRCT1032220253
Enrollment
80
Registered
2022-08-08
Start date
2022-08-08
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

EUS-HGS or ERC-BS for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion

Sponsors

Takahara Naminatsu
Lead Sponsor

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 with SEMS for recurrent biliary obstruction. 5) Adequate oral intake 6) Expecting survival time over 3 months

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 6) Indwelled gastrodeudonal stent covering duodenal papilla 7) Impossible endoscopic access to the duodenal papilla due to duodenal stenosis 8) Performance status of 3-4 9) Bleeding tendency (platelet count lower than 50,000/mm3, prothrombin time lower than 70%) 10) Impossible to discontinue or replace antithrombotic/anticoagulant agents 11) Heart failure (NYHA of III-IV) or respiratory failure (PaO2 lower than 60Torr) 12) Pregnant or at risk of becoming pregnant

Design outcomes

Primary

MeasureTime frame
Early recurrent biliary obstrucrion rate

Secondary

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

Contacts

Public ContactKohei Kurihara

The University of Tokyo Hospital

kurikuri.marron07@gmail.com+81-3-3815-5411

Outcome results

None listed

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