Preoperative endoscopic versus percutaneous biliary drainage in potentially resectable perihilar cholangiocarcinoma: DRAINAGE Trial

Completed

• Conditions: Klatskin tumor; perihilar bile duct tumor; Perihilar cholangiocarcinoma; 10019654

• Registration Number: NL-OMON41627
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

• Diagnosis of perihilar cholangiocarcinoma
• No apparent signs of irresectability on CT-scan and/or MRI, and scheduled to undergo a *curative* liver resection (may need additional lymph node biopsies or a diagnostic laparoscopy to further determine resectability);
• Inadequate preoperative biliary drainage.
For drainage naïve patients this is defined as:
* Serum bilirubin level >= 50 µmol/l;
For drainage non-naïve patients this is defined as:
* Persistent hyperbilirubinemia
* or inadequate drainage of the future remnant liver (stent positioned in contra-lateral side)
• Both the endoscopic and the percutaneous drainage methods are technically feasible.

Exclusion Criteria

• Incomplete recovery from side-effects of any prior stenting attempt, including signs of active cholangitis.
• ECOG/WHO score >=3
• Any other contraindication for major liver surgery
• No informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of drainage related complications between treatment allocation and<br /><br>explorative laparotomy. Complications in this composite endpoint are consist of:<br /><br>- Stent dysfunction<br /><br>- Cholangitis<br /><br>- Acute cholecystitis<br /><br>- Acute pancreatitis<br /><br>- Hemorrhage<br /><br>- Perforation<br /><br>- Portal vein thrombosis<br /><br>- Dehydration</p><br>