Endoscopic drainage of presumed resectable perihilar cholangiocarcinoma using a intrahepatic plastic stent with retrieval string; a pilot study (CHORDA-II-pilot)

Recruiting

• Conditions: bile duct cancer; 10019815; Cholangiocarcinoma

• Registration Number: NL-OMON53365
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients with presumed perihilar cholangiocarcinoma that are judged eligible
for major liver resection and require endoscopic biliary drainage of the future
liver remnant.

Exclusion Criteria

- Incompletely recovered from any side effects of previous biliary drainage
procedures
- Any contra-indication for major liver surgery
- Technical contra-indications for endobiliary drainage

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: number of severe drainage related complications between<br /><br>inclusion and exploratory laparotomy. In patients who will not undergo<br /><br>exploratory laparotomy, the number of drainage-related complications will be<br /><br>measured until 7 days after the decision to cancel exploratory laparotomy or 90<br /><br>days after inclusion, whichever comes first. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome will include technical and therapeutic success of biliary<br /><br>drainage, individual components of primary endpoints and quality of life.</p><br>