CholangitisNCT03104582
Best Biliary Drainage Option in Advanced Klatskin Tumor
A study testing ERCP Drainage and PTBD Drainage in people with Cholangitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholangitis
- What is being tested?
- ERCP Drainage and PTBD Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2011to 14 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II、III、IV Klatskin tumor patients;
- 18-90 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD
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).
Read the 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.
- Conditions
- Cholangitis
- Being tested
- ERCP Drainage, PTBD Drainage
- Keywords
- ERCP, PTBD, EBD, Cholangitis, Complication, Klatskin tumor
- Medical subject headings
- Cholangitis, Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP DrainageProcedure or surgery
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.
PTBD DrainageProcedure or surgery
When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Biliary drainage 1 | Experimental | Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage Receives: Procedure: ERCP Drainage |
| Biliary drainage 2 | Active comparator | Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage Receives: Procedure: PTBD Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute cholangitis
Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks
Measured: 2 weeks
Secondary outcomes (3)
Abdominal pain
Pain score (scores:1-10)
Measured: 2 weeks
Length of hospital stay
The total time of hospital stay
Measured: 6 months
Overall procedure related complication rate
Pancreatitis, bleeding, perforation, seeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Nov 2011
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Xun Li, M.D., Ph. D., Study director, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104582
- Sponsor's protocol ID
- Biliary drainage in KT
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2017
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32010755
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD
- ClinicalTrials.gov ID
- NCT03104582
- Acronym / sponsor ID
- Biliary drainage in KT
- Conditions
- Cholangitis
- Keywords
- ERCP, PTBD, EBD, Cholangitis, Complication, Klatskin tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliary drainage 1 | Experimental | Procedure: ERCP DrainagePatients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage |
| Biliary drainage 2 | Active comparator | Procedure: PTBD DrainagePatients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type II、III、IV Klatskin tumor patients;
- 18-90 years old
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP DrainageWhen advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent. | Procedure or surgery | Biliary drainage 1 |
| PTBD DrainageWhen advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent. | Procedure or surgery | Biliary drainage 2 |
Primary outcome
Acute cholangitis
Time frame: 2 weeks
Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks
3 secondary outcomes
Abdominal pain
Time frame: 2 weeks
Length of hospital stay
Time frame: 6 months
Overall procedure related complication rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Derived from this study: PubMed 32010755Ba 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xun Li, M.D., Ph. D. study director
Hepatopancreatobiliary Surgery Institute of Gansu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP Drainage and PTBD Drainage in people with Cholangitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute cholangitis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.