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

Primary Purpose

Perihilar Cholangiocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intrahepatic biliary stent with retrieval string
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perihilar Cholangiocarcinoma focused on measuring Biliary drainage, Intrahepatic plastic stent with retrieval string, Presumed resectable perihilar cholangiocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amsterdam UMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Intrahepatic plastic biliary stent with retrieval string

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The separate incidence of preoperative cholangitis between inclusion and exploratory laparotomy
Number of patients who experience preoperative cholangitis.
Technical success of intervention
The number of drainage procedures required to achieve technical success.
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.
Number of drainage procedures between inclusion and exploratory laparotomy
The total number of drainage procedures that involved (attempted) stent (re-)placement.
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.
Cancellation of surgery
The number of patients with rescheduled or cancelled laparotomy due to severe drainage-related complications.
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.
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.
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.
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.
Postoperative mortality
Number of patients experiencing postoperative mortality

Full Information

First Posted
February 16, 2023
Last Updated
May 23, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05874934
Brief Title
Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String
Acronym
CHORDA-II-p
Official Title
Endoscopic Drainage of Presumed Resectable Perihilar Cholangiocarcinoma Using an Intrahepatic Plastic Stent With Retrieval String; a Pilot Study (CHORDA-II-pilot)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perihilar Cholangiocarcinoma
Keywords
Biliary drainage, Intrahepatic plastic stent with retrieval string, Presumed resectable perihilar cholangiocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intrahepatic plastic biliary stent with retrieval string
Intervention Type
Device
Intervention Name(s)
Intrahepatic biliary stent with retrieval string
Intervention Description
Plastic biliary stent with 3-0 nylon (ethilon) thread tied to the distal end of the stent through the existing sidehole.
Primary Outcome Measure Information:
Title
Severe adverse events between inclusion and exploratory laparotomy
Description
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
Secondary Outcome Measure Information:
Title
The separate incidence of preoperative cholangitis between inclusion and exploratory laparotomy
Description
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
Title
Technical success of intervention
Description
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
Title
Therapeutic success of intervention within 14 days
Description
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
Title
Number of drainage procedures between inclusion and exploratory laparotomy
Description
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
Title
Bilirubin levels after 7 and 14 days
Description
Interval bilirubin decrease at 7 days and 14 days after biliary drainage relative to the bilirubin level at inclusion.
Time Frame
14 days
Title
Cancellation of surgery
Description
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
Title
Quality of life after 7 days.
Description
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
Title
Quality of life after 28 days.
Description
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
Title
Quality of life after 90 days.
Description
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
Title
Postoperative morbidity
Description
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
Title
Postoperative mortality
Description
Number of patients experiencing postoperative mortality
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeska A. Fritzsche, MD
Phone
+20 444 0613
Email
j.a.fritzsche@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogier P. Voermans
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeska A. Fritzsche, MD
Phone
+20 444 0613
Email
j.a.fritzsche@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Rogier P. Voermans, MD PhD
First Name & Middle Initial & Last Name & Degree
Jeska A. Fritzsche, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Pending

Learn more about this trial

Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String

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