Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

Hilar Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108145
• Other study ID #: XHDD-004
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2014
• Est. completion date: December 2021

Study information

• Verified date: August 2019
• Source: Fourth Military Medical University
• Contact: Guohong Han, MD,Ph.D
• Phone: 86-29-84771528
• Email: hangh[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 ?????obstruction; 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 ?type 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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hilar Cholangiocarcinoma
• Klatskin Tumor

Intervention

Procedure:
• bilateral metal stent insertion

• unilateral metal stent insertion

Locations

Country	Name	City	State
China	Han Guo Hong	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stent patency	Stent patency is a secondary endpoint of this study. Cumulative stent patency rate is compared between the two groups.	up to 1year
Other	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
Other	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
Primary	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	Median survival		up to 1 year