Jaundice, ObstructiveNCT03527875
Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice
A study testing PTBD group, ENBD group and EBS group in people with Jaundice, Obstructive and Klatskin Tumor, run by Shanghai Zhongshan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Jaundice, Obstructive, Klatskin Tumor
- What is being tested?
- PTBD group, ENBD group and EBS group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the following four criteria are included into the study:
- Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
- Serum total bilirubin is higher than 51 umol/l;
- Age is older than 18 and younger than 80 years old;
- Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.
Who cannot join
- If any of the following items are met, the subject cannot enter the study.
- Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
- Malignant obstructive jaundice caused by metastatic tumors;
- Pregnancy or lactation women.
Trial locations and contacts
No sites are listed yet.
About this study
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
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).
- Conditions
- Jaundice, Obstructive, Klatskin Tumor
- Being tested
- PTBD group, ENBD group, EBS group
- Medical subject headings
- Jaundice, Obstructive, Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTBD groupProcedure or surgery
Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
ENBD groupProcedure or surgery
Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
EBS groupProcedure or surgery
Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
| Study group | Role | What they receive |
|---|---|---|
| PTBD group | Experimental | Percutaneous Transhepatic Biliary Drainage Receives: Procedure: PTBD group |
| ENBD group | Experimental | Endoscopic Nasobiliary Biliary Drainage Receives: Procedure: ENBD group |
| EBS group | Experimental | Endoscopic Biliary Stenting Receives: Procedure: EBS group |
| Without PBD group | No intervention | receive surgery without PBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate after drainage
Complication rate between PBD (preoperative biliary drainage) and radical surgery
Measured: From PBD to completion of radical surgery, an average of 1 month
Complication rate after radical surgery
Complication rate after radical surgery
Measured: 1 month post operatively
Success rate of PBD
Success rate of different methods of PBD
Measured: Day 1
Secondary outcomes (7)
operative time
duration of radical surgery
Measured: Day 1
Hepatoduodenal edema
Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)
Measured: at time of radical surgery
Perioperative mortality
Mortality between PBD and 4 weeks after surgery
Measured: from PBD to 4 weeks after surgery, an average of 2 month
implantation metastasis
Rate of implantation metastasis
Measured: Day 1
Rate of change in Total bilirubin
Recovery efficiency of liver function
Measured: 2 weeks after PBD
Rate of change in alanine aminotransferase
Recovery efficiency of liver function
Measured: 2 weeks after PBD
Rate of change in aspartate aminotransferase
Recovery efficiency of liver function
Measured: 2 weeks after PBD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study startAug 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, ObstructiveStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527875
- Sponsor's protocol ID
- 2018ZSLC24
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03527875
- Acronym / sponsor ID
- 2018ZSLC24
- Conditions
- Jaundice, Obstructive, Klatskin Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 17 May 2018 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PTBD group | Experimental | Procedure: PTBD groupPercutaneous Transhepatic Biliary Drainage |
| ENBD group | Experimental | Procedure: ENBD groupEndoscopic Nasobiliary Biliary Drainage |
| EBS group | Experimental | Procedure: EBS groupEndoscopic Biliary Stenting |
| Without PBD group | No intervention | –receive surgery without PBD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the following four criteria are included into the study:
Key exclusion criteria (4 listed)
- If any of the following items are met, the subject cannot enter the study.
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 |
|---|---|---|
| PTBD groupPercutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients | Procedure or surgery | PTBD group |
| ENBD groupEndoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients | Procedure or surgery | ENBD group |
| EBS groupEndoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients | Procedure or surgery | EBS group |
Primary outcome
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
Complication rate after radical surgery
Time frame: 1 month post operatively
Complication rate after radical surgery
Success rate of PBD
Time frame: Day 1
Success rate of different methods of PBD
7 secondary outcomes
operative time
Time frame: Day 1
Hepatoduodenal edema
Time frame: at time of radical surgery
Perioperative mortality
Time frame: from PBD to 4 weeks after surgery, an average of 2 month
implantation metastasis
Time frame: Day 1
Rate of change in Total bilirubin
Time frame: 2 weeks after PBD
Rate of change in alanine aminotransferase
Time frame: 2 weeks after PBD
Rate of change in aspartate aminotransferase
Time frame: 2 weeks after PBD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing PTBD group, ENBD group and EBS group in people with Jaundice, Obstructive and Klatskin Tumor, run by Shanghai Zhongshan Hospital.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Houbao Liu, PHD (13818971698, houbaoliu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate after drainage (time frame: From PBD to completion of radical surgery, an average of 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2018.