bile duct tumor, jaundice, biliary drainage
Conditions
Interventions
Crossover treatment:
Crossover treatment applies to patients who require a repeat or revision procedure, but in whom the allocated drainage modality is no longer technically feasible. Cross-over trea
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: Changed 17-jun-2014 - Diagnosis or suspicion of perihilar cholangiocarcinoma (pHCCA) - No apparent signs of irresectability on CT-scan and/or MRI, and scheduled to undergo a “curative” liver resection (may need additional lymph node biopsies or a diagnostic laparoscopy to further determine resectability)
Exclusion criteria
Exclusion criteria: - Incomplete recovery from side-effects of any prior stenting attempt - Signs of active cholangitis, defined as Leukocytes ≥ 10 *109/L or antibiotic treatment for a suspicion of cholangitis within the past 5 days - ECOG/WHO score ≥3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined incidence of severe complications related to EBD or PTBD between the initial drainage after treatment allocation (i.e. the index drainage procedure) and the day of explorative laparotomy. A severe complication is defined as any complication related to biliary drainage, requiring an additional invasive or surgical intervention with subsequent prolonged hospital stay or death, or readmission for drainage related morbidity. When explorative laparotomy is cancelled a substitute endpoint will be used in analysis of the primary endpoint: (1) the total number of severe drainage-related complications between randomization and 1 week after biopsy in patients in whom the laparotomy is cancelled due to a diagnosis of distant metastatic disease, or (2) the total number of severe drainage-related complications within 3 months after randomization in patients in whom the laparotomy is cancelled due to physical deterioration. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Technical success of the index drainage procedure; defined as appropriate stent/catheter placement through the stenosis into the segments of the FRL after maximum 2 procedures. - Time (days) from treatment allocation until therapeutic success. - Number of procedures required to achieve therapeutic success. - Adequate biliary drainage for explorative laparotomy; defined as a serum Bilirubin level below 50 μmol/L measured at the day before explorative laparotomy. - Number of drainage interventions; defined as the total number of preoperative biliary drainage procedures that include stent (re-)placement or attempts at stent placement. - Time from drainage until explorative laparotomy; defined as the number of days between inclusion and explorative laparotomy. - All surgical procedures will be scheduled at standardised time intervals to allow analysis of the time to explorative laparotomy. However, some patients may experience a delay in surgery due to organisational issues. Therefore, the number of patients with rescheduled laparotomy for clinical reasons (i.e. the patients physical condition does not allow surgery) will also be an outcome measure. Patients with postponed laparotomies for organisational reasons are not included in this outcome measure. - Quality of Life; assessed using the Short-Form Health Survey (SF-36), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-30), the EORTC QOL module for cholangiocarcinoma and gallbladder cancer (EORTC QLQ-BIL21), and the EuroQol 5D (EQ-5D). - 90-day post-laparotomy mortality. - 90-day post-laparotomy morbidity. - Individual components of the primary endpoint (special interest to incidence of cholangitis) | — |
Contacts
Public ContactT.M. Gulik, van
Academic Medical Center (AMC), Department of Surgery P.O. Box 226600 Meibergdreef 9
Outcome results
None listed