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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016422
Enrollment
Unknown
Registered
2018-06-01
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor of extrahepatic bile duct

Interventions

Group ENBD:Endoscopic Nasobiliary Drainage
Group PTBD:Percutaneous Transhepatic Biliary Drainage
Group EBS:Endoscopic Biliary Stenting

Sponsors

General surgery department, Zhongshan hospital affiliated Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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 plann for radical surgery; 2) Serum total bilirubin greater than 51 umol/l; 3) Aged 18 to 80 years old; 4) Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

Exclusion criteria

Exclusion criteria: If any of the following items are combined, 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.

Design outcomes

Primary

MeasureTime frame
complication rate of PBD;success rate of PBD;Perioperative complication rate;Liver function recovery efficiency;

Secondary

MeasureTime frame
Implantation metastasis rate;operation time;Bleeding amount of surgery;edema of Hepatoduodenal ligament;mortality of perioperative period;postoperative hospital stay;Total hospitalization costs;Total length of stay in hospital;

Countries

China

Contacts

Public ContactHoubao Liu

General surgery department, Zhongshan hospital affiliated Fudan University

houbaoliu@aliyun.com+86 15901669460

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026