Pancreatic cancer
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Early recurrent biliary obstrucrion rate | — |
Secondary
| Measure | Time 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
The University of Tokyo Hospital