Metal stents are safe and a feasible for preoperative biliary draqinage for resectable perihilar cholangiocarcinoma
ID
Bron
Verkorte titel
Aandoening
Perihilar cholangiocarcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective of this study is to assess the feasibility of ucSEMS placement in patients with resectable pCCA defined as:
· At least 70% of patients with technical successful ucSEMS placement, that is:
o Placed in the segment(s) to be drained as determined by the multidisciplinary meeting, with a preferred margin of at least 1 cm proximally and distally across the stenosis
o Bilirubin decrease of at least 20% after 7 days
o No need for additional biliary drainage intervention (ERCP and/or PTCD)
Achtergrond van het onderzoek
Biliary drainage in patients with perihilar cholangiocarcinoma is often performed by endoscopic placement of plastic or metal stents. Preoperatively this is mostly limited to plastic stents, but these are known to have limited patency time. The uncovered self-expanding metal stent allows for more rapid biliary decompression and has a reduced occlusion rate when compared to plastic stents. However, there is limited published evidence about the application of ucSEMS in the preoperative setting.
Doel van het onderzoek
Metal stents are safe and a feasible for preoperative biliary draqinage for resectable perihilar cholangiocarcinoma
Onderzoeksopzet
Imaging, ERCP (Intervention), surgery (if performed)
Onderzoeksproduct en/of interventie
ucSEMS placement by ERCP
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• High suspicion of resectable pCCA on imaging (as determined by the multidisciplinary hepatobiliary team, with or without histopathological confirmation) And
• Preoperative endoscopic drainage is indicated (as determined by the multidisciplinary hepatobiliary team) And
• Written informed consent according to ICH/GCP, and national/local regulations. And
• Age > 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Patients who underwent previous drainage procedures by endoscopy with plastic stent placement or percutaneously with an (internalized) biliary catheter; And
• Bismuth type I pCCA (as determined by the multidisciplinary hepatobiliary team); And
• Prior diagnosis of Primary Sclerosing Cholangitis (PSC)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9600 |
| Ander register | METC EMC : MEC-2021-0420 |