Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String (CHORDA-II-p)

May 23, 2023 updated by: Rogier P. Voermans, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Endoscopic Drainage of Presumed Resectable Perihilar Cholangiocarcinoma Using an Intrahepatic Plastic Stent With Retrieval String; a Pilot Study (CHORDA-II-pilot)

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Amsterdam, Netherlands, 1081HV
        • Recruiting
        • Amsterdam UMC
        • Principal Investigator:
          • Rogier P. Voermans, MD PhD
        • Contact:
        • Sub-Investigator:
          • Jeska A. Fritzsche, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intrahepatic plastic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe adverse events between inclusion and exploratory laparotomy
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The separate incidence of preoperative cholangitis between inclusion and exploratory laparotomy
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
Number of patients who experience preoperative cholangitis.
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
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 number of drainage procedures required to achieve technical success.
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
Time Frame: 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.
14 days
Number of drainage procedures between inclusion and exploratory laparotomy
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 total number of drainage procedures that involved (attempted) stent (re-)placement.
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
Time Frame: 14 days
Interval bilirubin decrease at 7 days and 14 days after biliary drainage relative to the bilirubin level at inclusion.
14 days
Cancellation of surgery
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 number of patients with rescheduled or cancelled laparotomy due to severe drainage-related complications.
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.
Time Frame: 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.
7 days
Quality of life after 28 days.
Time Frame: 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.
28 days
Quality of life after 90 days.
Time Frame: 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.
90 days
Postoperative morbidity
Time Frame: 30 days after surgery
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.
30 days after surgery
Postoperative mortality
Time Frame: 30 days after surgery
Number of patients experiencing postoperative mortality
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rogier P. Voermans, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Pending

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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