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Best Biliary Drainage Option in Advanced Klatskin Tumor

Primary Purpose

Cholangitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERCP Drainage
PTBD Drainage
Sponsored by
Hepatopancreatobiliary Surgery Institute of Gansu Province
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangitis focused on measuring ERCP, PTBD, EBD, Cholangitis, Complication, Klatskin tumor

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biliary drainage 1

Biliary drainage 2

Arm Description

Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage

Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage

Outcomes

Primary Outcome Measures

Acute cholangitis
Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks

Secondary Outcome Measures

Abdominal pain
Pain score (scores:1-10)
Length of hospital stay
The total time of hospital stay
Overall procedure related complication rate
Pancreatitis, bleeding, perforation, seeding

Full Information

First Posted
March 25, 2017
Last Updated
July 10, 2019
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
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1. Study Identification

Unique Protocol Identification Number
NCT03104582
Brief Title
Best Biliary Drainage Option in Advanced Klatskin Tumor
Official Title
Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2011 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangitis
Keywords
ERCP, PTBD, EBD, Cholangitis, Complication, Klatskin tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biliary drainage 1
Arm Type
Experimental
Arm Description
Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage
Arm Title
Biliary drainage 2
Arm Type
Active Comparator
Arm Description
Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage
Intervention Type
Procedure
Intervention Name(s)
ERCP Drainage
Intervention Description
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.
Intervention Type
Procedure
Intervention Name(s)
PTBD Drainage
Intervention Description
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.
Primary Outcome Measure Information:
Title
Acute cholangitis
Description
Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Abdominal pain
Description
Pain score (scores:1-10)
Time Frame
2 weeks
Title
Length of hospital stay
Description
The total time of hospital stay
Time Frame
6 months
Title
Overall procedure related complication rate
Description
Pancreatitis, bleeding, perforation, seeding
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Li, M.D., Ph. D.
Organizational Affiliation
Hepatopancreatobiliary Surgery Institute of Gansu Province
Official's Role
Study Director
Facility Information:
Facility Name
Hepatopancreatobiliary Surgery Institute of Gansu Province
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32010755
Citation
Ba Y, Yue P, Leung JW, Wang H, Lin Y, Bai B, Zhu X, Zhang L, Zhu K, Wang W, Meng W, Zhou W, Liu Y, Li X. Percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma. Endosc Int Open. 2020 Feb;8(2):E203-E210. doi: 10.1055/a-0990-9114. Epub 2020 Jan 22.
Results Reference
derived

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Best Biliary Drainage Option in Advanced Klatskin Tumor

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