Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02108145

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hilar Cholangiocarcinoma	Procedure: bilateral metal stent insertion Procedure: unilateral metal stent insertion	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Median survival [up to 1 year]

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.