To evaluate safety and efficacy of endobiliary RFA as a treatment for biliary SEMS occlusion caused by tissue ingrowth.
ID
Source
Brief title
Condition
- Other condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Health condition
pancreascarcinoom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biliary patency, defined as the time period between study intervention and
biliary re-obstruction.
Secondary outcome
technical success; clinical success; complications; hospitalisation; median
survival
Background summary
Patients with unresectable malignant bile duct obstruction with a life
expectancy longer than 3 months are usually treated with self-expandable metal
stents (SEMSs) to ensure continued biliary drainage. However patency of these
stents is limited due to stent occlusion, which is mainly caused by tissue
ingrowth. This complication requires re-intervention in the majority of cases,
which consists of insertion of an additional biliary stent (stent-in-stent) or
percutaneous biliary drainage. Endobiliary applied radiofrequency ablation
(RFA) is a relatively new endoscopic technique that might be used to clear
biliary SEMS that are occlude by tissue ingrowth.
Study objective
To evaluate safety and efficacy of endobiliary RFA as a treatment for biliary
SEMS occlusion caused by tissue ingrowth.
Study design
Multicenter non-randomized prospective open-label feasibility study
Intervention
Application of endobiliary RFA with the HabibTM EndoHPB device at the site of
biliary obstruction during 2 minutes at a power setting of 7 Watt.
Study burden and risks
Very few complications should be expected with regards to the insertion of the
EndoHPB catheter over a guidewire into the CBD, which should be no different
compared to other standard catheters used during endoscopic retrograde
cholangiopancreatography (ERCP). On activation of EndoHPB, the luminal use of
RFA is intended to produce local coagulative necrosis of the tissue that
occludes the biliary SEMS. Potential complications associated with the local
application of heat include damage to surrounding healthy tissue leading to
perforation, biliary leak or abscess formation. These complications have not
been found in previous clinical studies and risks are minimized by using the
power settings determined in an in vivo porcine model.
Patients may experience the study follow-up calls as a burden. A potential
benefit of endobiliary RFA may be a prolonged biliary patency, which could
eventually be reflected in better quality of life and a low number of long-term
complications.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
• Patients with unresectable malignant common bile duct obstruction caused by pancreatic head carcinoma or distal cholangiocarcinoma who have been treated previously with a biliary uncovered SEMS
• Recurrent biliary obstruction caused by SEMS occlusion due to tissue ingrowth, requiring treatment
• A clinical diagnosis of obstructive jaundice in combination with a bilirubin level of >40 µmol/L and
Exclusion criteria
• Patients with a (malignant) biliary obstruction due to other causes than pancreatic head cancer or cholangiocarcinoma
• Evidence of new additional more proximally located biliary strictures
• Clinical suspicion of cholangitis, defined as biliary obstruction in combination with fever (temperature >= 38,5°C)
• Presence of a plastic stent in the common bile duct.
• Patients who are unable to undergo ERCP due to their medical condition
• Patients suffering form concurrent gastric outlet obstruction
• Patients with a cardiac pacemaker
• Patients with a WHO performance score of 4
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL43040.018.12 |
| OMON | NL-OMON20857 |