Clinical trial NCT05874934: Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String
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
Overall status: UNKNOWN
Phase: NA
Conditions: Perihilar Cholangiocarcinoma
Keywords: Biliary drainage
Intrahepatic plastic stent with retrieval string
Presumed resectable perihilar cholangiocarcinoma
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective pilot study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Severe adverse events between inclusion and exploratory laparotomy
timeFrame: 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:
measure: The separate incidence of preoperative cholangitis between inclusion and exploratory laparotomy
timeFrame: 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
measure: Technical success of intervention
timeFrame: 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
measure: Therapeutic success of intervention within 14 days
timeFrame: 14 days
measure: Number of drainage procedures between inclusion and exploratory laparotomy
timeFrame: 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
measure: Bilirubin levels after 7 and 14 days
timeFrame: 14 days
measure: Cancellation of surgery
timeFrame: 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
measure: Quality of life after 7 days.
timeFrame: 7 days
measure: Quality of life after 28 days.
timeFrame: 28 days
measure: Quality of life after 90 days.
timeFrame: 90 days
measure: Postoperative morbidity
timeFrame: 30 days after surgery
measure: Postoperative mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Rogier P. Voermans
role: PRINCIPAL_INVESTIGATOR
References: