Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

NCT ID: NCT02108145

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Hilar Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

unilateral metal stent insertion

unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume

Group Type: ACTIVE_COMPARATOR

unilateral metal stent insertion

Intervention Type: PROCEDURE

bilateral metal stent insertion

percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS

Group Type: EXPERIMENTAL

bilateral metal stent insertion

Intervention Type: PROCEDURE

Interventions

bilateral metal stent insertion

Intervention Type: PROCEDURE

unilateral metal stent insertion

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Guohong Han

Head of Department of Digestive Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guohong Han, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

Han Guo Hong

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guohong Han, MD,Ph.D

Role: CONTACT

hangh@fmmu.edu.cn

86-29-84771528

MingWu Li, MD

Role: CONTACT

lmw_jack@china.com.cn

Facility Contacts

guohong han, M.D.

Role: primary

hangh2009@gmail.com

+86-29-84771537 ext. +86-29-8253904

Other Identifiers

XHDD-004

Identifier Type: -

Identifier Source: org_study_id