An interventional study of Intrahepatic biliary stent with retrieval string in Perihilar Cholangiocarcinoma, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
Prospective pilot study to assess the feasibility and efficacy of intrahepatic plastic biliary stents with a retrieval string in patients with presumed resectable perihilar cholangiocarcinoma requiring biliary drainage of the future liver remnant.
Background: 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-interventions, re-admissions, delay of diagnostic work-up and potential surgery. Biliary drainage could be optimized by the use of a navel 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.
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 population: Patients with presumed perihilar cholangiocarcinoma that are judged eligible for major liver resection and require endoscopic biliary drainage of the future liver remnant.
lntervention: Endoscopic drainage of the future liver remnant using a plastic biliary stent with retrieval string (diameter 7 or 1 0Fr).
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 study parameters/outcome of the study (if applicable):
Secondary outcomes: technical and therapeutic success of biliary drainage, individual components of primary endpoints and quality of life.
86 studies on the registry are indexed under Klatskin Tumor; 26 are open to participants now.
This study's enrollment of 40 is below the median of 56 across 57 interventional studies indexed under Klatskin Tumor.
Browse Klatskin Tumor studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Intrahepatic plastic biliary stent with retrieval string
Device: Intrahepatic biliary stent with retrieval string
Plastic biliary stent with 3-0 nylon (ethilon) thread tied to the distal end of the stent through the existing sidehole.
Severe adverse events between inclusion and exploratory laparotomy
Number of severe drainage related complications between inclusion and exploratory laparotomy. Severe complications are defined as any complication leading to additional invasive interventions, (extended) hospitalization, or death.
Time frame: Between inclusion and surgery. 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
The separate incidence of preoperative cholangitis between inclusion and exploratory laparotomy
Number of patients who experience preoperative cholangitis.
Time frame: Between inclusion and surgery. 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
Technical success of intervention
The number of drainage procedures required to achieve technical success.
Time frame: Between inclusion and surgery. 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
Therapeutic success of intervention within 14 days
The number of patients who with therapeutic success, defined as normal caliber bile ducts in the future liver remnant on ultrasound examination and a decrease in total bilirubin concentration of at least 20% at day 7 relative to the concentration at baseline.
Time frame: 14 days
Number of drainage procedures between inclusion and exploratory laparotomy
The total number of drainage procedures that involved (attempted) stent (re-)placement.
Time frame: Between inclusion and surgery. 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
Bilirubin levels after 7 and 14 days
Interval bilirubin decrease at 7 days and 14 days after biliary drainage relative to the bilirubin level at inclusion.
Time frame: 14 days
Cancellation of surgery
The number of patients with rescheduled or cancelled laparotomy due to severe drainage-related complications.
Time frame: Between inclusion and surgery. 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
Quality of life after 7 days.
EORTC Quality of Life Questionnaire 30 (EORTC QLQ-30), the EORTC QLQ module for CCA and gallbladder cancer (EORTC QLQ-BIL21), and the EuroQol 5D (EQ-5D-5L). Scoring according to module, higher score means better outcome.
Time frame: 7 days
Quality of life after 28 days.
EORTC Quality of Life Questionnaire (EORTC QLQ-30 incl BIL-21 module and EQ-5D-5L). Scoring according to module, higher score means better outcome.
Time frame: 28 days
Quality of life after 90 days.
EORTC Quality of Life Questionnaire (EORTC QLQ-30 incl BIL-21 module and EQ-5D-5L). Scoring according to module, higher score means better outcome.
Time frame: 90 days
Postoperative morbidity
EORTC Quality of Life Questionnaire (EORTC QLQ-30 incl BIL-21 module and EQ-5D-5L). Scoring according to module, higher score means better outcome.
Time frame: 30 days after surgery
Postoperative mortality
Number of patients experiencing postoperative mortality
Time frame: 30 days after surgery
Plan to share: Undecided — Pending
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)