An interventional study of PTBD group and ENBD group in Jaundice, Obstructive and Klatskin Tumor, sponsored by Shanghai Zhongshan Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention
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).
62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.
This study's planned enrollment of 564 is above the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.
Browse Jaundice, Obstructive studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet the following four criteria are included into the study:
Exclusion Criteria:
If any of the following items are met, the subject cannot enter the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percutaneous Transhepatic Biliary Drainage
Procedure: PTBD group
Endoscopic Nasobiliary Biliary Drainage
Procedure: ENBD group
Endoscopic Biliary Stenting
Procedure: EBS group
receive surgery without PBD
Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
Complication rate after drainage
Complication rate between PBD (preoperative biliary drainage) and radical surgery
Time frame: From PBD to completion of radical surgery, an average of 1 month
Complication rate after radical surgery
Complication rate after radical surgery
Time frame: 1 month post operatively
Success rate of PBD
Success rate of different methods of PBD
Time frame: Day 1
operative time
duration of radical surgery
Time frame: Day 1
Hepatoduodenal edema
Degree of hepatoduodenal edema (including no edema, mild edema, moderate edema, and severe edema)
Time frame: at time of radical surgery
Perioperative mortality
Mortality between PBD and 4 weeks after surgery
Time frame: from PBD to 4 weeks after surgery, an average of 2 month
implantation metastasis
Rate of implantation metastasis
Time frame: Day 1
Rate of change in Total bilirubin
Recovery efficiency of liver function
Time frame: 2 weeks after PBD
Rate of change in alanine aminotransferase
Recovery efficiency of liver function
Time frame: 2 weeks after PBD
Rate of change in aspartate aminotransferase
Recovery efficiency of liver function
Time frame: 2 weeks after PBD
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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