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Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice

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ClinicalTrials.gov Identifier: NCT03527875
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).

Condition or disease Intervention/treatment Phase
Jaundice, Obstructive Klatskin Tumor Procedure: PTBD group Procedure: ENBD group Procedure: EBS group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice of Extrahepatic Bile Duct: A Multi-center, Prospective, Open-labeled, Real World Study Based on Electronic Data Capture System
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTBD group
Percutaneous Transhepatic Biliary Drainage
Procedure: PTBD group
Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Experimental: ENBD group
Endoscopic Nasobiliary Biliary Drainage
Procedure: ENBD group
Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

Experimental: EBS group
Endoscopic Biliary Stenting
Procedure: EBS group
Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients

No Intervention: Without PBD group
receive surgery without PBD



Primary Outcome Measures :
  1. Complication rate after drainage [ Time Frame: From PBD to completion of radical surgery, an average of 1 month ]
    Complication rate between PBD (preoperative biliary drainage) and radical surgery

  2. Complication rate after radical surgery [ Time Frame: 1 month post operatively ]
    Complication rate after radical surgery

  3. Success rate of PBD [ Time Frame: Day 1 ]
    Success rate of different methods of PBD


Secondary Outcome Measures :
  1. operative time [ Time Frame: Day 1 ]
    duration of radical surgery

  2. Hepatoduodenal edema [ Time Frame: at time of radical surgery ]
    Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)

  3. Perioperative mortality [ Time Frame: from PBD to 4 weeks after surgery, an average of 2 month ]
    Mortality between PBD and 4 weeks after surgery

  4. implantation metastasis [ Time Frame: Day 1 ]
    Rate of implantation metastasis

  5. Rate of change in Total bilirubin [ Time Frame: 2 weeks after PBD ]
    Recovery efficiency of liver function

  6. Rate of change in alanine aminotransferase [ Time Frame: 2 weeks after PBD ]
    Recovery efficiency of liver function

  7. Rate of change in aspartate aminotransferase [ Time Frame: 2 weeks after PBD ]
    Recovery efficiency of liver function



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet the following four criteria are included into the study:

    1. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
    2. Serum total bilirubin is higher than 51 umol/l;
    3. Age is older than 18 and younger than 80 years old;
    4. Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

Exclusion Criteria:

  • If any of the following items are met, the subject cannot enter the study.

    1. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
    2. Malignant obstructive jaundice caused by metastatic tumors;
    3. Pregnancy or lactation 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): NCT03527875


Contacts
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Contact: Houbao Liu, PHD 13818971698 houbaoliu@aliyun.com

Sponsors and Collaborators
Shanghai Zhongshan Hospital

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03527875     History of Changes
Other Study ID Numbers: 2018ZSLC24
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cholangiocarcinoma
Jaundice
Jaundice, Obstructive
Klatskin Tumor
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms