Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 40 for:    "Klatskin tumor"

Best Biliary Drainage Option in Advanced Klatskin Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03104582
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary:
To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).

Condition or disease Intervention/treatment Phase
Cholangitis Procedure: ERCP Drainage Procedure: PTBD Drainage Not Applicable

Detailed Description:
Operative treatment combined with preoperative biliary drainage (PBD) has been established as a safe management strategy for KT. Preoperative cholangitis was an independent risk factor for patients undergoing resection for KT. However, controversy exists regarding the preferred technique for PBD.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor:ERCP or PTBD
Actual Study Start Date : November 1, 2011
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biliary drainage 1
Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage
Procedure: ERCP Drainage
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.

Active Comparator: Biliary drainage 2
Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage
Procedure: PTBD Drainage
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.




Primary Outcome Measures :
  1. Acute cholangitis [ Time Frame: 2 weeks ]
    Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks


Secondary Outcome Measures :
  1. Abdominal pain [ Time Frame: 2 weeks ]
    Pain score (scores:1-10)

  2. Length of hospital stay [ Time Frame: 6 months ]
    The total time of hospital stay

  3. Overall procedure related complication rate [ Time Frame: 6 months ]
    Pancreatitis, bleeding, perforation, seeding



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II、III、IV Klatskin tumor patients;
  • 18-90 years old

Exclusion Criteria:

  • Unwillingness or inability to consent for the study;
  • Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count(<50×109 / L) or using anti-coagulation drugs;
  • Previous endoscopic sphincterectomy (EST) or endoscopic papillary balloon dilatation (EPBD);
  • Any type of GI reconstruction;
  • Combined with Mirizzi syndrome and intrahepatic bile duct stones;
  • Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock;
  • Biliary-duodenal fistula;
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104582


Locations
Layout table for location information
China, Gansu
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, China, 730000
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
Layout table for investigator information
Study Director: Xun Li, M.D., Ph. D. Hepatopancreatobiliary Surgery Institute of Gansu Province

Layout table for additonal information
Responsible Party: Wenbo Meng, M.D., Ph. D,, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT03104582     History of Changes
Other Study ID Numbers: Biliary drainage in KT
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province:
ERCP
PTBD
EBD
Cholangitis
Complication
Klatskin tumor

Additional relevant MeSH terms:
Layout table for MeSH terms
Klatskin Tumor
Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms