No registrations found.
ID
Source
Brief title
Health condition
bile duct tumor, jaundice, biliary drainage
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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)
Background summary
Cholestasis is a significant risk factor in the treatment of patients with suspected hilar cholangiocarcinoma (HCCA) requiring major liver resection. Preoperative biliary drainage (PBD) attenuates the effects of cholestasis caused by the tumor, but there is controversy over the preferred technique of PBD, either via endoscopic biliary drainage (EBD) or using percutaneous transhepatic biliary drainage (PTBD).
The objective of this multi-center randomized controlled trial is to identify a difference in the incidence of drainage related complications between EBD and PTBD for preoperative biliary drainage of HCCA.
Inclusion criteria: Suspicion of resectable HCCA; serum bilirubine >50 µmol/l; inadequate biliary drainage of the future remnant liver.
Main exclusion criteria: Incomplete recovery from side effects of any prior stenting procedure; contraindication for major surgery.
Intervention: Patients will be allocated to undergo either EBD or PTBD.
Primary endpoint: The incidence of severe drainage related complications between the index drainage procedure and explorative laparotomy, defined as any complication requiring an additional invasive intervention or hospital admission.
Secondary endpoints: Technical success of stent insertion; the time from drainage until explorative laparotomy; number of rescheduled laparotomies for clinical reasons; length of hospital stay; number of invasive procedures; post-laparotomy morbidity and mortality; quality of life.
This study is expected to identify PTBD as the preferred technique of preoperative biliary drainage for resectable HCCA on the basis of fewer drainage related complications and consequential better quality of life. Furthermore postoperative mortality and morbidity is expected to decrease with PTBD compared to EBD.
Study objective
This study is expected to identify less complications after percutaneous biliary drainage (PTBD) compared to endoscopic biliary drainage for resectable hilar cholangiocarcinoma.
Study design
Therapeutic success: control ultrasound of the liver 7 days after index drainage procedure and control bilirubin 7 and 14 days after index drainage procedure. Quality of life (EORTC QLQ-30, EORTC QLQ-BIL21, EQ-5D): date of inclusion (baseline), 7, 28 and 90 days after index drainage procedure.
Intervention
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 treatment from EBD to PTBD is protocol mandatory if EBD is unsuccessful to achieve technical success after 2 attempts.
Antibiotics: Standard antibiotic prophylaxes are administered at the start of each biliary drainage procedure, according to local protocol. Prophylactic antibiotic treatments must be similar for endoscopic and percutaneous biliary drainage procedures in each centre. Cholangitis is treated with intravenous
antibiotics, preferably 2 grams ceftriaxone i.v plus gentamicine 5mg/kg, during hospital admission.
P.O. Box 226600
Meibergdreef 9
T.M. Gulik, van
Amsterdam 1100 DD
The Netherlands
Tel +31 20 56 65570
r.j.coelen@amc.uva.nl
P.O. Box 226600
Meibergdreef 9
T.M. Gulik, van
Amsterdam 1100 DD
The Netherlands
Tel +31 20 56 65570
r.j.coelen@amc.uva.nl
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4098 |
| NTR-old | NTR4243 |
| Other | KWF cancer foundation grant : 5925 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |