Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Percutaneous Bilateral Versus Unilateral Metal Stent Placement for Hilar Cholangiocarcinoma : A Prospective Open-label Randomized Controlled Trial

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC). A majority of the CCA (50-70%) was presented in the area of the biliary duct bifurcation. Recent retrospective study included heterogeneous group of malignant diseases demonstrate that draining more than 50% of was associated with a longer median survival.

However, in recent European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma (HCCA), whether we should deployment bilateral or unilateral metal stent for patients with HCCA was not clearly recommended due to the absence of randomized controlled trials.

Study Overview

• Status: Unknown
• Conditions: Hilar Cholangiocarcinoma
• Intervention / Treatment: Procedure: unilateral metal stent insertion; Procedure: bilateral metal stent insertion

Detailed Description

Patients with advanced hilar obstruction (Bismuth III and IV), PTBS had a higher success rate of cholestasis palliation and a low rate of post cholangitis when compared with endoscopic retrograde cholangiopancreatography(ERCP). The advantage of percutaneous approach is the precise lobar selection for drainage and this approach should yield a lower rate of cholangitis.

Guideline recommendation European Society of Gastrointestinal Endoscopy (ESGE) biliary stenting clinical guideline and Asia-Pacific consensus recommendations the goal of palliative stenting of HCCA is drainage of adequate liver volume (50% or more), irrespective of unilateral, bilateral, or multi-segmental stenting was based on heterogeneous group of malignancy by ERCP in retrospective study.There are no randomized clinical trials compared with these two internal biliary drainage methods in HCCA using metal stent.

The aim of the present study was to compare the effect and safety of bilateral versus unilateral stenting in patients with HCCA.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Guohong Han, MD,Ph.D; Phone Number: 86-29-84771528; Email: hangh@fmmu.edu.cn
• Study Contact Backup: Name: MingWu Li, MD; Email: lmw_jack@china.com.cn

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Han Guo Hong
      • Contact: guohong han, M.D.; Phone Number: +86-29-8253904 +86-29-84771537; Email: hangh2009@gmail.com
      • Sub-Investigator: mingwu Li, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Written informed consent; Jaundice duo to biliary obstruction; The diagnosis is based on typical features on MRI and magnetic resonance cholangiopancreatography or histologic and cytologic confirmation is established by percutaneous biopsy (X ray-guided) or exploratory laparotomy; Bismuth type Ⅱ、Ⅲ、Ⅳobstruction; Performance status (eastern cooperative oncology group, ECOG) 0-2; All patients were considered unsuitable or refuse for resection on the basis of general medical condition and/or tumor extent.

Exclusion Criteria:

Refuse to participate and provide informed consent; Bismuth Ⅰtype obstruction; Performance status (eastern cooperative oncology group, ECOG) 3-4. Portal Vein involvement; Prior history of stent; Concomitant renal insufficiency; Severe cardiopulmonary diseases; Uncontrolled systemic infection or sepsis; Accompany other malignancy or serious medical illness which may reduce the life expectancy.

Contraindications for PTBS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: unilateral metal stent insertion; unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume	Procedure: unilateral metal stent insertion
Experimental: bilateral metal stent insertion; percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS	Procedure: bilateral metal stent insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure to control jaundice or failure to prevent stent occlusion or re-jaundice within three month after stent implantation	From stent insertion to three months

Secondary Outcome Measures

Outcome Measure	Time Frame
Median survival	up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent patency	Stent patency is a secondary endpoint of this study. Cumulative stent patency rate is compared between the two groups.	up to 1year
Early major complications	Early major complications is a secondary endpoint of this study.Early major complications rate is compared between the two groups	30 days within treatment
30-day mortality	30-day mortality is a secondary endpoint of this study. 30-day mortality rate is compared between the two groups.	30 days within treatment

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Guohong Han, MD,Ph.D, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: cholangiocarcinoma; metal stent; jaundice; PTBS
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: XHDD-004