To explore feasibility and efficacy of endoscopic drainage of patients with presumed perihilar cholangiocarcinoma eligible for major liver resection using a plastic stent with a retrieval string.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: number of severe drainage related complications between
inclusion and exploratory laparotomy. In patients who will not undergo
exploratory laparotomy, the number of drainage-related complications will be
measured until 7 days after the decision to cancel exploratory laparotomy or 90
days after inclusion, whichever comes first.
Secondary outcome
Secondary outcome will include technical and therapeutic success of biliary
drainage, individual components of primary endpoints and quality of life.
Background summary
Pre-operative biliary drainage is advised to treat obstructive jaundice and
optimize the clinical condition of patients with presumed resectable perihilar
cholangiocarcinoma who are expected to be eligible for major liver resection.
However, stent related complications such as cholangitis (37%) and stent
dysfunction (19%) occur frequently. Creating the need for numerous
re-inventions, re-admissions, delay of diagnostic work-up and potential
surgery. Biliary drainage could be optimized by the use of a novel design short
fully covered self-expanding metal stent (FCSEMS) which is currently examined
in the CHORDA-pilot study. However, FCSEMS placement is not feasible in an
considerable number of cases, in these patients the use of a plastic stent with
a retrieval string could be beneficial over standard plastic stent placement,
which makes removal possible although the stent does not reach into the
duodenum.
Study objective
To explore feasibility and efficacy of endoscopic drainage of patients with
presumed perihilar cholangiocarcinoma eligible for major liver resection using
a plastic stent with a retrieval string.
Study design
Prospective cohort pilot study.
Intervention
Endoscopic drainage of the future liver remnant using a plastic biliary stent
with retrieval string (diameter 7 or 10Fr).
Study burden and risks
Because the stent does not bridge the papilla, risk of ascending cholangitis
might be lower. Besides the use of a different stent, patients receive standard
of care. Additionally, patients are requested to fill out questionnaires
concerning their quality of life at baseline, 7 days, 28 days and 90 days after
inclusion.
Boelelaan 1118
Amsterdam 1081 HV
NL
Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients with presumed perihilar cholangiocarcinoma that are judged eligible
for major liver resection and require endoscopic biliary drainage of the future
liver remnant.
Exclusion criteria
- Incompletely recovered from any side effects of previous biliary drainage
procedures
- Any contra-indication for major liver surgery
- Technical contra-indications for endobiliary drainage
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 | NL83570.018.22 |