JRCT ID: jRCT1032220253
Registered date:08/08/2022
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
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Pancreatic cancer |
Date of first enrollment | 08/08/2022 |
Target sample size | 80 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | EUS-HGS or ERC-BS for distal malignant biliary obstruction in pancreatic cancer complicated with duodenal invasion |
Outcome(s)
Primary Outcome | Early recurrent biliary obstrucrion rate |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Nakai Yousuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Naminatsu Takahara |
Address | 7-3-1, Hongo Bunkyo-ku, Tokyo, Japan Tokyo Japan 113-8655 |
Telephone | +81-3-3815-5411 |
naminatsu-takahara@g.ecc.u-tokyo.ac.jp | |
Affiliation | The University of Tokyo Hospital |
Scientific contact | |
Name | Yousuke Nakai |
Address | 7-3-1, Hongo Bunkyo-ku, Tokyo, Japan Tokyo Japan 113-8655 |
Telephone | +81-3-3815-5411 |
ynakai-tky@umin.ac.jp | |
Affiliation | The University of Tokyo Hospital |