A Phase 2/3 interventional study of bilateral metal stent insertion and unilateral metal stent insertion in Hilar Cholangiocarcinoma, sponsored by Air Force Military Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by Air Force Military Medical University, China · Phase 2/3, Interventional, and Treatment
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.
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.
88 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.
This study's planned enrollment of 70 is above the median of 55 across 58 interventional studies indexed under Klatskin Tumor.
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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.
unilateral metal stent insertion was performed either left or right hepatic lobe as can be drainage more liver volume
Procedure: unilateral metal stent insertion
percutaneous transhepatic biliary drainage plus bilateral metal stent.The bare stents were used for PTBS
Procedure: bilateral metal stent insertion
Failure to control jaundice or failure to prevent stent occlusion or re-jaundice within three month after stent implantation
Time frame: From stent insertion to three months
Median survival
Time frame: up to 1 year
Stent patency
Stent patency is a secondary endpoint of this study. Cumulative stent patency rate is compared between the two groups.
Time frame: 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
Time frame: 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.
Time frame: 30 days within treatment
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China →