Perihilar cholangiocarcinoma
Conditions
Interventions
ucSEMS placement by ERCP
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: oPlaced 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 oBilirubin decrease of at least 20% after 7 days oNo need for additional biliary drainage intervention (ERCP and/or PTCD) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to assess the safety of ucSEMS placement in patients with resectable pCCA by using the following parameters: · A maximum of 50% of patients with severe post-procedural complications. Complications are defined and subcategorized as: o Endoscopic (ucSEMS placement) ? Moderate or severe post-ERCP pancreatitis: defined as (i) new or worsened abdominal pain; (ii) new or prolonged hospitalization for at least two days; and (iii) serum amylase or lipase > threefold upper limit of normal, measured >24h after the procedure, according to the Atlanta Revised Criteria (17) ? Cholangitis, which was defined as both fever (i.e. body temperature >38.5°C) and leucocytosis (i.e. =10 *109/L) without clinical or radiological evidence of acute cholecystitis, requiring prolonged antibiotics and re-intervention ? Radiologic evidence of cholecystitis, elevation in temperature more than 38.5°C and Leukocytes =10*109/L, and requirement of percutaneous drainage or emergency cholecystectomy. ? Major Bleeding: defined as a hemoglobin drop of >3g/dl requiring any re-intervention (endoscopic, angiographic, surgical) ? Perforation: defined as evidence of air or luminal contents outside the gastro-intestinal tract together with clinical symptoms, requiring percutaneous drainage or surgery o Stent-related (after placement) ? Stent dislocation ? Stent occlusion ? Bile leakage requiring re-intervention (percutaneous, endoscopic, or surgical) ? Intra-abdominal abscess requiring drainage · Technical success of stent removal, defined as successful removal during surgery by the surgeon on a range from 0 – 10 and duration of removal · Accuracy of extent of the tumor on CT, MRCP and ERCP in comparison with pathological resection specimens. | — |
Contacts
Public ContactDavid de Jong
Erasmus University MC
Outcome results
None listed