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

NCT ID: NCT05874934

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-05-31

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.

Conditions

Perihilar Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Intrahepatic plastic biliary stent with retrieval string

Group Type: EXPERIMENTAL

Intrahepatic biliary stent with retrieval string

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Rogier P. Voermans

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rogier P. Voermans

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Amsterdam UMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jeska A. Fritzsche, MD

Role: CONTACT

j.a.fritzsche@amsterdamumc.nl

+20 444 0613

Facility Contacts

Jeska A. Fritzsche, MD

Role: primary

j.a.fritzsche@amsterdamumc.nl

+20 444 0613

Other Identifiers

NL83570.018.22

Identifier Type: OTHER

Identifier Source: secondary_id

2021.0249

Identifier Type: -

Identifier Source: org_study_id