Percutaneous Bilateral Versus Unilateral Metal Stent for Hilar Cholangiocarcinoma

NCT02108145 | Unknown Phase 2

• 1 other identifier: XHDD-004
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hilar Cholangiocarcinoma

Keywords

cholangiocarcinoma; jaundice; metal stent; PTBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Median survival

  up to 1 year

Other Outcomes (3)

• Stent patency

  up to 1year

• Early major complications

  30 days within treatment

• 30-day mortality

  30 days within treatment

Study Arms (2)

unilateral metal stent insertion

ACTIVE COMPARATOR

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

Procedure: unilateral metal stent insertion

bilateral metal stent insertion

EXPERIMENTAL

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

Procedure: bilateral metal stent insertion

Interventions

bilateral metal stent insertion PROCEDURE

bilateral metal stent insertion

unilateral metal stent insertion PROCEDURE

unilateral metal stent insertion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Han Guo Hong

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor; Cholangiocarcinoma; Jaundice

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Guohong Han, MD,Ph.D

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohong Han, MD,Ph.D

CONTACT

86-29-84771528; hangh@fmmu.edu.cn

MingWu Li, MD

CONTACT

lmw_jack@china.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Digestive Interventional Radiology

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 9, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 1, 2019

Record last verified: 2019-08

Locations

CN (1)