NCT05874934

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

February 16, 2023

Last Update Submit

May 23, 2023

Conditions

Perihilar Cholangiocarcinoma

Keywords

Biliary drainageIntrahepatic plastic stent with retrieval stringPresumed resectable perihilar cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Secondary Outcomes (11)

  • The separate incidence of preoperative cholangitis between inclusion and exploratory laparotomy

    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

    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

    14 days

  • Number of drainage procedures between inclusion and exploratory laparotomy

    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

    14 days

  • +6 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Intrahepatic plastic biliary stent with retrieval string

Device: Intrahepatic biliary stent with retrieval string

Interventions

Intrahepatic biliary stent with retrieval stringDEVICE

Plastic biliary stent with 3-0 nylon (ethilon) thread tied to the distal end of the stent through the existing sidehole.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older.
  • Capable of providing written and oral informed consent.
  • Presumed perihilar cholangiocarcinoma.
  • Biliary obstruction in the future liver remnant.
  • Drainage naïve patients: total bilirubin \>50 umol/L
  • Patients with previous endobiliary drainage procedures: persistently rising total bilirubin \>50 umol/L (i.e. no stent placed or insufficient draining stent) or persistent biliary dilatation in the future liver remnant on imaging (i.e. previous stent placed in contralateral side of the liver).

You may not qualify if:

  • Incompletely recovered from any side effects of previous biliary drainage procedures. Patients are required to be off antibiotic treatment for at least 5 days.
  • Any contra-indication for major liver surgery (e.g. ECOG/WHO score ≥3).
  • Technical contra-indications for endobiliary drainage (e.g. previous gastrojejunostomy).
  • Distance between stricture and sphincter less than 2 cm.
  • Refusal to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, 1081HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Rogier P. Voermans

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeska A. Fritzsche, MD

CONTACT

+20 444 0613j.a.fritzsche@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2023

First Posted

May 25, 2023

Study Start

March 1, 2023

Primary Completion

February 29, 2024

Study Completion

May 31, 2024

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

NL(1)