Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05874934
Status:
RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-02-16
Brief Title:
Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Endoscopic Drainage of Presumed Resectable Perihilar Cholangiocarcinoma Using an Intrahepatic Plastic Stent With Retrieval String a Pilot Study CHORDA-II-pilot
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHORDA-II-p
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 parametersoutcome of the study if applicable
Secondary outcomes technical and therapeutic success of biliary drainage individual components of primary endpoints and quality of life
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 parametersoutcome of the study if applicable
Secondary outcomes technical and therapeutic success of biliary drainage individual components of primary endpoints and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8357001822 | OTHER | CCMO | None |