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NCT Number: NCT03104582

Best Biliary Drainage Option in Advanced Klatskin Tumor

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).

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Key information

Conditions

Cholangitis Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases Carcinoma Cholangiocarcinoma Digestive System Diseases Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP Drainage

Procedure

When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.

PTBD Drainage

Procedure

When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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