The aim is to evaluate whether the use of eRFA prior to stenting prolongs stent patency in patients with biliary obstruction due to inoperable perihilar cholangocarcinoma.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the time to biliary obstruction.
Secondary outcome
Secondary endpoints include technical and functional success, the effect on
quality of life, overall survival, adverse events, number of re-interventions,
time to re-interventions, need for external drains, and evaluation of the
effect of repeated eRFA on stent patency.
Background summary
At time of diagnosis, only about 15-20% of the patients with cholangiocarcinoma
qualify for curative resection. Consequently, the majority of patients need
optimal palliative care. Due to tumour growth in the bile ducts almost all
patients with perihilar cholangiocarcinoma develop bile duct obstruction in the
course of their disease. Palliative treatment consists of placement of biliary
stents to relieve this obstruction in combination with systemic therapy.
However, stent patency is known to be short due to ingrowth of the tumour. This
leads to recurrent cholangitis, sepsis, re-interventions and admissions, delay
or cancellation of chemotherapy, permanent external drainage catheters, and, if
adequate drainage cannot be achieved, death. The use of endobiliary
radiofrequency ablation (eRFA) has been described as a promising adjuvant
therapy to prolong stent patency and subsequent survival and quality of life.
Study objective
The aim is to evaluate whether the use of eRFA prior to stenting prolongs stent
patency in patients with biliary obstruction due to inoperable perihilar
cholangocarcinoma.
Study design
A multicentre, parallel group, open label, randomized controlled trial.
Intervention
eRFA prior to placement of an uncovered self-expanding metal stent (or plastic
stent in case not feasible) compared with stent placement only.
Study burden and risks
It is hypothesized that eRFA leads to increased stent patency, less
re-interventions, less (permanent) external drains, and consequently increased
quality of life and survival. Adverse events (2-6%) have been reported after
eRFA, however according to meta-analysis only temporary abdominal discomfort
(31 vs 20%) seems to occur significantly more often in patients who underwent
eRFA prior to stenting compared with stent placement only. Patients are
requested to fill out questionnaires concerning their quality of life at
baseline, 1 month, and every 3 months after intervention. Conform standard of
care a telephonic or consult at the outpatient clinic in combination with
laboratory tests will be performed at baseline, and 2 weeks, 1 month and every
3 months after intervention.
Boelelaan 1118
Amsterdam 1081 HV
NL
Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older.
- Capable of providing written and oral informed consent.
- Histological or cytological proof of perihilar cholangiocarcinoma
(adenocarcinoma).
- Perihilar biliary obstruction with indication for drainage with uSEMS.*
- Advanced (no candidate for surgical resection) due to metastases, vascular or
lymph node (N2). involvement on imaging or during staging laparoscopy according
to multidisciplinary team (MDT).
*Only patients with pCCA are eligible however in case of reasonable doubt
between intrahepatic CCA with a perihilar biliary obstruction or massforming
pCCA, patients can be included.
Exclusion criteria
- Patients who potentially qualify for curative resection of pCCA.
- pCCA eligible for liver transplantation.
- Life-expectancy less than 3 months.
- ERCP and PTC technically not feasible.
- Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below
40*10E9/L).
- Ongoing cholangitis or liver abscess. Patients are required to be off
antibiotic treatment for cholangitis and/or liver abscess at least 7 days.
- Any condition that is unstable or that could jeopardize the safety of the
subject and their compliance in the study.
- Patients who are pregnant or breastfeeding.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL76591.029.22 |